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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03886805
Other study ID # U1111-1229-1346
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 30, 2019
Est. completion date March 5, 2020

Study information

Verified date July 2021
Source University of Pernambuco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study analyzed the effect of different modalities of dual-task training in the improvement of gait biomechanics, postural balance, falls episodes, executive functioning, and quality of life in community-dwelling older adults. Half of the participants have undertaken a dual-task protocol training with progression from variable-priority to fixed-priority instructions, while the other half have undertaken a dual-task protocol training under variable-priority instructions.


Description:

Although dual-task training for improving postural balance is an emerging interest area, the effects of dual tasks and dual-task training on static and dynamic postural stability remain unclear. Even though variable (alternating) instructional priority dual-task training has been shown higher effect than fixed (concurrent) priority dual-task training approach to improving the balance impairments, we must consider in everyday pragmatic situations, motor, and cognitive tasks are often demanded simultaneously and this requires an individual's attention toward an external source of attention while performing a primary task. Then, our rationale for this study is older adults who underwent a training protocol composed of a dual task with variable and fixed instructional priority will achieve better improvements regarding the studied variables in comparison to the group who will be submitted a protocol composed only by dual-task with variable priority training. Therefore, this protocol for a six-month, double-blind, randomized controlled trial with six-month follow-up post-training analyzed whether examine whether a dual-task protocol training with progression from variable priority to fixed priority instructions is effective in improvement of gait biomechanics, postural balance, falls episodes, executive functioning and quality of life in community-dwelling older adults.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 5, 2020
Est. primary completion date March 5, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion criteria: - Participants of both sexes - Age between 60 and 80 years old - Participants with a score greater or equal to 52 (up to a maximum of 56) in the Berg Balance Scale - Participants with a score greater or equal to 24 (up to a maximum of 30) in the Mini-mental State Exam - Participants who are able to walk uninterruptedly for a distance of 10-meter at a self-selected velocity of at least 1.0 m/s without the need from another person, cane or walker Exclusion criteria: - Self-report of two or more falls in the last 12 months - Any contraindication to balance postural training - Any contraindication to cognitive exercise training - With self-report of two or more falls in the last 12 months - Who is participating or have participated, in the last 6 months, in any regular and structured physical exercise program, for 3 or more times per week - Any chronic health condition, including cardiovascular disease, respiratory disease, stroke, active cancer, neurological or neuromuscular conditions whose exercise is contraindicated - Any upper or lower limb fracture in the last 6 months - Evidence of any surgical procedures in the knees, ankles, and hips or muscle damage in the last 6 months - Uncontrolled diabetes. - No able to speak and understand the Portuguese language - Refusal to give informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Dual task with variable- and fixed-priority instructions
The participants were asked to perform dual-task activities focused, interchangeable or simultaneously, on balance (motor tasks) and on cognitive tasks performance, according to the instructional priority established by the physical therapist.
Dual-task with variable-priority instructions
The participants were asked to spend half the session focused on balance (motor tasks) and half the session focused on cognitive tasks performance, according to the instructional priority established by the physical therapist.

Locations

Country Name City State
Brazil Francis Trombini de Souza Petrolina Pernambucano

Sponsors (2)

Lead Sponsor Collaborator
University of Pernambuco Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gait spatiotemporal variables These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously). Post-randomization at week 12
Primary Gait spatiotemporal variables These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously). Post-randomization at week 24
Primary Gait spatiotemporal variables These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously). Post-intervention at week 12
Primary Gait spatiotemporal variables These variables will be acquired by a couple of inertial sensors attached on participant's feet during walking on a 30-meter flat and level corridor under a single-task (only gait), dual-task under variable- (gait alternating with a cognitive task) and fixed-priority (gait and cognitive task performing simultaneously). Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task These biomechanical variable acquired during gait under single task will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task These biomechanical variable acquired during gait under single task will be assessed by an inertial sensor fixed on the participant's waist. Post-radomization at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task These biomechanical variable acquired during gait under single task will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during gait under single task These biomechanical variable acquired during gait under single task will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction These biomechanical variable acquired during gait under dual-task with variable-priority instruction will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction These biomechanical variable acquired during gait under dual-task with variable-priority instruction will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction These biomechanical variable acquired during gait under dual-task with variable-priority instruction will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with variable-priority instruction These biomechanical variable acquired during gait under dual-task with variable-priority instruction will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction These biomechanical variable acquired during gait under dual-task with fixed-priority instruction will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction These biomechanical variable acquired during gait under dual-task with fixed-priority instruction will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction These biomechanical variable acquired during gait under dual-task with fixed-priority instruction will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during gait under dual-task with fixed-priority instruction These biomechanical variable acquired during gait under dual-task with fixed-priority instruction will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test. These biomechanical variable acquired during conventional timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test. These biomechanical variable acquired during conventional timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test. These biomechanical variable acquired during conventional timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during conventional timed up and go test. These biomechanical variable acquired during conventional timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test. These biomechanical variable acquired during manual timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test. These biomechanical variable acquired during manual timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test. These biomechanical variable acquired during manual timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during manual timed up and go test. These biomechanical variable acquired during manual timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test. These biomechanical variable acquired during cognitive timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test. These biomechanical variable acquired during cognitive timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test. These biomechanical variable acquired during cognitive timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during cognitive timed up and go test. These biomechanical variable acquired during cognitive timed up and go test will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture These biomechanical variable acquired during performing the Stroop test in quasi-static standing posture will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture These biomechanical variable acquired during performing the Stroop test in quasi-static standing posture will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture These biomechanical variable acquired during performing the Stroop test in quasi-static standing posture will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Stroop test in quasi-static standing posture These biomechanical variable acquired during performing the Stroop test in quasi-static standing posture will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB). These biomechanical variable acquired during performing the Clinical Test of Sensory Interaction and Balance (CTSIB) will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB). These biomechanical variable acquired during performing the Clinical Test of Sensory Interaction and Balance (CTSIB) will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB). These biomechanical variable acquired during performing the Clinical Test of Sensory Interaction and Balance (CTSIB) will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity and displacement of the body center of mass during performing the Clinical Test of Sensory Interaction and Balance (CTSIB). These biomechanical variable acquired during performing the Clinical Test of Sensory Interaction and Balance (CTSIB) will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test. These biomechanical variable acquired during performing the Anterior Functional Reach test will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test. These biomechanical variable acquired during performing the Anterior Functional Reach test will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test. These biomechanical variable acquired during performing the Anterior Functional Reach test will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Anterior Functional Reach test. These biomechanical variable acquired during performing the Anterior Functional Reach test will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair. These biomechanical variable acquired during performing the Five Times Sit-to-stand test from a chair will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair. These biomechanical variable acquired during performing the Five Times Sit-to-stand test from a chair will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair. These biomechanical variable acquired during performing the Five Times Sit-to-stand test from a chair will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Five Times Sit-to-stand test from a chair. These biomechanical variable acquired during performing the Five Times Sit-to-stand test from a chair will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor. These biomechanical variable acquired during performing the Sitting-rising test from the floor will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor. These biomechanical variable acquired during performing the Sitting-rising test from the floor will be assessed by an inertial sensor fixed on the participant's waist. Post-randomization at week 24
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor. These biomechanical variable acquired during performing the Sitting-rising test from the floor will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 12
Secondary Tri-axial acceleration, angular velocity, and displacement of the body center of mass during performing the Sitting-rising test from the floor. These biomechanical variable acquired during performing the Sitting-rising test from the floor will be assessed by an inertial sensor fixed on the participant's waist. Post-intervention at week 24
Secondary Timed Up and Go conventional (TUG conventional) Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair. Post-randomization at week 12
Secondary Timed Up and Go conventional (TUG conventional) Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair. Post-randomization at week 24
Secondary Timed Up and Go conventional (TUG conventional) Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair. Post-intervention at week 12
Secondary Timed Up and Go conventional (TUG conventional) Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair. Post-intervention at week 24
Secondary Timed Up and Go manual (TUG manual) Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair, while the participant carries a dish with a cup on it. Post-randomization at week 12
Secondary Timed Up and Go manual (TUG manual) Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair, while the participant carries a dish with a cup on it. Post-randomization at week 24
Secondary Timed Up and Go manual (TUG manual) Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair, while the participant carries a dish with a cup on it. Post-intervention at week 12
Secondary Timed Up and Go manual (TUG manual) Test of basic mobility skills analyzed during rising from a chair, walking, turning the obstacle, and sitting again on the chair, while the participant carries a dish with a cup on it. Post-intervention at week 24
Secondary Timed Up and Go cognitive (TUG cognitive) Test the basic mobility skills analyzed during raising from a chair, walking, bypassing the obstacle, and sitting back in the chair while the participant performs a concurrent cognitive task (solving mathematical subtraction operations). Post-randomization at week 12
Secondary Timed Up and Go cognitive (TUG cognitive) Test the basic mobility skills analyzed during raising from a chair, walking, bypassing the obstacle, and sitting back in the chair while the participant performs a concurrent cognitive task (solving mathematical subtraction operations). Post-randomization at week 24
Secondary Timed Up and Go cognitive (TUG cognitive) Test the basic mobility skills analyzed during raising from a chair, walking, bypassing the obstacle, and sitting back in the chair while the participant performs a concurrent cognitive task (solving mathematical subtraction operations). Post-intervention at week 12
Secondary Timed Up and Go cognitive (TUG cognitive) Test the basic mobility skills analyzed during raising from a chair, walking, bypassing the obstacle, and sitting back in the chair while the participant performs a concurrent cognitive task (solving mathematical subtraction operations). Post-intervention at week 24
Secondary Postural Balance Test (PBT) The Postural Balance Test evaluate the static and dynamic balance, in order to verify the typology of motor regulation, i.e. the exteroceptive or visual (six items) and interoceptive or vestibular (eight items), besides the general - proprioceptive information - of the movements. Post-randomization at week 12
Secondary Postural Balance Test (PBT) The Postural Balance Test evaluate the static and dynamic balance, in order to verify the typology of motor regulation, i.e. the exteroceptive or visual (six items) and interoceptive or vestibular (eight items), besides the general - proprioceptive information - of the movements. Post-randomization at week 24
Secondary Postural Balance Test (PBT) The Postural Balance Test evaluate the static and dynamic balance, in order to verify the typology of motor regulation, i.e. the exteroceptive or visual (six items) and interoceptive or vestibular (eight items), besides the general - proprioceptive information - of the movements. Post-intervention at week 12
Secondary Postural Balance Test (PBT) The Postural Balance Test evaluate the static and dynamic balance, in order to verify the typology of motor regulation, i.e. the exteroceptive or visual (six items) and interoceptive or vestibular (eight items), besides the general - proprioceptive information - of the movements. Post-intervention at week 24
Secondary Clinical Test of Sensory Interaction and Balance (CTSIB) This test will be used to assess the sensory integration on postural balance during standing on a stable and unstable surface with eyes open and closed. Post-randomization at week 12
Secondary Clinical Test of Sensory Interaction and Balance (CTSIB) This test will be used to assess the sensory integration on postural balance during standing on a stable and unstable surface with eyes open and closed. Post-randomization at week 24
Secondary Clinical Test of Sensory Interaction and Balance (CTSIB) This test will be used to assess the sensory integration on postural balance during standing on a stable and unstable surface with eyes open and closed. Post-intervention at week 12
Secondary Clinical Test of Sensory Interaction and Balance (CTSIB) This test will be used to assess the sensory integration on postural balance during standing on a stable and unstable surface with eyes open and closed. Post-intervention at week 24
Secondary Stroop test in sit posture This test will be used to measure a participant's selective attention capacity and skills, as well as his/her processing speed ability in sit posture Post-randomization at week 12
Secondary Stroop test in sit posture This test will be used to measure a participant's selective attention capacity and skills, as well as his/her processing speed ability in sit posture Post-randomization at week 24
Secondary Stroop test in sit posture This test will be used to measure a participant's selective attention capacity and skills, as well as his/her processing speed ability in sit posture Post-intervention at week 12
Secondary Stroop test in a quasi-static standing posture This test will be used to measure a participant's selective attention capacity and skills, as well as his/her processing speed ability in quasi-static standing posture. Post-intervention at week 24
Secondary Trail making test (TMT) Trail making test will be used to assess the participants executive abilities, which requires a variety of mental abilities including letter and number recognition mental flexibility, visual scanning, and motor function of upper limbs Post-randomization at week 12
Secondary Trail making test (TMT) Trail making test will be used to assess the participants executive abilities, which requires a variety of mental abilities including letter and number recognition mental flexibility, visual scanning, and motor function of upper limbs Post-randomization at week 24
Secondary Trail making test (TMT) Trail making test will be used to assess the participants executive abilities, which requires a variety of mental abilities including letter and number recognition mental flexibility, visual scanning, and motor function of upper limbs Post-intervention at week 12
Secondary Trail making test (TMT) Trail making test will be used to assess the participants executive abilities, which requires a variety of mental abilities including letter and number recognition mental flexibility, visual scanning, and motor function of upper limbs Post-intervention at week 24
Secondary Five Times Sit-to-Stand test from a chair The functional performance of the lower limbs taken to lifting and sitting on a chair for five times. The time will be measured by a stopwatch Post-randomization at week 12
Secondary Five Times Sit-to-Stand test from a chair The functional performance of the lower limbs taken to lifting and sitting on a chair for five times. The time will be measured by a stopwatch Post-randomization at week 24
Secondary Five Times Sit-to-Stand test from a chair The functional performance of the lower limbs taken to lifting and sitting on a chair for five times. The time will be measured by a stopwatch Post-intervention at week 12
Secondary Five Times Sit-to-Stand test from a chair The functional performance of the lower limbs taken to lifting and sitting on a chair for five times. The time will be measured by a stopwatch Post-intervention at week 24
Secondary Sitting-and-rising test from the floor Sitting-and-rising test from the floor will be used to quantify how many supports (hands and/or knees or, still, hands on the knees or legs) the individual uses to sit and lift from the floor. Post-randomization at week 12
Secondary Sitting-and-rising test from the floor Sitting-and-rising test from the floor will be used to quantify how many supports (hands and/or knees or, still, hands on the knees or legs) the individual uses to sit and lift from the floor. Post-randomization at week 24
Secondary Sitting-and-rising test from the floor Sitting-and-rising test from the floor will be used to quantify how many supports (hands and/or knees or, still, hands on the knees or legs) the individual uses to sit and lift from the floor. Post-intervention at week 12
Secondary Sitting-and-rising test from the floor Sitting-and-rising test from the floor will be used to quantify how many supports (hands and/or knees or, still, hands on the knees or legs) the individual uses to sit and lift from the floor. Post-intervention at week 24
Secondary Anterior functional reach test Anterior functional reach test will be used to determine how far the participants are able to move forward within their stability limit. It is widely used to identify the risk of falling in older adults Post-randomization at week 12
Secondary Anterior functional reach test Anterior functional reach test will be used to determine how far the participants are able to move forward within their stability limit. It is widely used to identify the risk of falling in older adults Post-randomization at week 24
Secondary Anterior functional reach test Anterior functional reach test will be used to determine how far the participants are able to move forward within their stability limit. It is widely used to identify the risk of falling in older adults Post-intervention at week 12
Secondary Anterior functional reach test Anterior functional reach test will be used to determine how far the participants are able to move forward within their stability limit. It is widely used to identify the risk of falling in older adults Post-intervention at week 24
Secondary Falls Efficacy Scale-International (FES-I) The 16-item Falls Efficacy Scale-International will be used to measure the participant's fear of falling (the concerns about falling). The sum of all 16 items is considered to compute a total score. The higher the total score achieved by the participant, the higher the concerns about falling. Post-randomization at week 12
Secondary Falls Efficacy Scale-International (FES-I) The 16-item Falls Efficacy Scale-International will be used to measure the participant's fear of falling (the concerns about falling). The sum of all 16 items is considered to compute a total score. The higher the total score achieved by the participant, the higher the concerns about falling. Post-randomization at week 24
Secondary Falls Efficacy Scale-International (FES-I) The 16-item Falls Efficacy Scale-International will be used to measure the participant's fear of falling (the concerns about falling). The sum of all 16 items is considered to compute a total score. The higher the total score achieved by the participant, the higher the concerns about falling. Post-intervention at week 12
Secondary Falls Efficacy Scale-International (FES-I) The 16-item Falls Efficacy Scale-International will be used to measure the participant's fear of falling (the concerns about falling). The sum of all 16 items is considered to compute a total score. The higher the total score achieved by the participant, the higher the concerns about falling. Post-intervention at week 24
Secondary Activities-specific Balance Confidence (ABC Scale) The 16-item Activities-specific Balance Confidence Scale will be used to measure the level of balance confidence of the individual during the accomplishment in performing daily activities. The higher the total score achieved by the participant, the higher the level of balance confidence and functioning in daily activities Post-randomization at week 12
Secondary Activities-specific Balance Confidence (ABC Scale) The 16-item Activities-specific Balance Confidence Scale will be used to measure the level of balance confidence of the individual during the accomplishment in performing daily activities. The higher the total score achieved by the participant, the higher the level of balance confidence and functioning in daily activities Post-randomization at week 24
Secondary Activities-specific Balance Confidence (ABC Scale) The 16-item Activities-specific Balance Confidence Scale will be used to measure the level of balance confidence of the individual during the accomplishment in performing daily activities. The higher the total score achieved by the participant, the higher the level of balance confidence and functioning in daily activities Post-intervention at week 12
Secondary Activities-specific Balance Confidence (ABC Scale) The 16-item Activities-specific Balance Confidence Scale will be used to measure the level of balance confidence of the individual during the accomplishment in performing daily activities. The higher the total score achieved by the participant, the higher the level of balance confidence and functioning in daily activities Post-intervention at week 24
Secondary Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Medical Outcomes Study 36-Item Short-Form Health Survey will be used to evaluate the quality of life of the participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability Post-randomization at week 12
Secondary Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Medical Outcomes Study 36-Item Short-Form Health Survey will be used to evaluate the quality of life of the participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability Post-randomization at week 24
Secondary Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Medical Outcomes Study 36-Item Short-Form Health Survey will be used to evaluate the quality of life of the participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability Post-intervention at week 12
Secondary Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Medical Outcomes Study 36-Item Short-Form Health Survey will be used to evaluate the quality of life of the participants. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability Post-intervention at week 24
Secondary Short form of the Geriatric Depression Scale (GDS-15) This 15-item instrument will be used to evaluate the suggestive depression symptoms in the participants. Its items require a yes/no response. Answers indicating depression are in bold and italicized; score one point for each one selected. Each answer "yes" marked with X in questions 3, 4, 6, 8, 9, 10, 12, 14 and 15 or answer "no" noted in questions 1, 5, 7, 11 and 13, computes 1 point. A score of 0 to 5 is normal. A score greater than 5 indicates depression Post-randomization at week 12
Secondary Short form of the Geriatric Depression Scale (GDS-15) This 15-item instrument will be used to evaluate the suggestive depression symptoms in the participants. Its items require a yes/no response. Answers indicating depression are in bold and italicized; score one point for each one selected. Each answer "yes" marked with X in questions 3, 4, 6, 8, 9, 10, 12, 14 and 15 or answer "no" noted in questions 1, 5, 7, 11 and 13, computes 1 point. A score of 0 to 5 is normal. A score greater than 5 indicates depression Post-randomization at week 24
Secondary Short form of the Geriatric Depression Scale (GDS-15) This 15-item instrument will be used to evaluate the suggestive depression symptoms in the participants. Its items require a yes/no response. Answers indicating depression are in bold and italicized; score one point for each one selected. Each answer "yes" marked with X in questions 3, 4, 6, 8, 9, 10, 12, 14 and 15 or answer "no" noted in questions 1, 5, 7, 11 and 13, computes 1 point. A score of 0 to 5 is normal. A score greater than 5 indicates depression Post-intervention at week 12
Secondary Short form of the Geriatric Depression Scale (GDS-15) This 15-item instrument will be used to evaluate the suggestive depression symptoms in the participants. Its items require a yes/no response. Answers indicating depression are in bold and italicized; score one point for each one selected. Each answer "yes" marked with X in questions 3, 4, 6, 8, 9, 10, 12, 14 and 15 or answer "no" noted in questions 1, 5, 7, 11 and 13, computes 1 point. A score of 0 to 5 is normal. A score greater than 5 indicates depression Post-intervention at week 24
Secondary The falls events Fall events will be evaluated through a falls diary, delivered monthly by each participant. The participants should note in this diary the day and the fall causes and circumstances. Post-randomization at week 12
Secondary The falls events Fall events will be evaluated through a falls diary, delivered monthly by each participant. The participants should note in this diary the day and the fall causes and circumstances. Post-randomization at week 24
Secondary The falls events Fall events will be evaluated through a falls diary, delivered monthly by each participant. The participants should note in this diary the day and the fall causes and circumstances. Post-intervention at week 12
Secondary The falls events Fall events will be evaluated through a falls diary, delivered monthly by each participant. The participants should note in this diary the day and the fall causes and circumstances. Post-intervention at week 24
See also
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