Older People Gait: Physiomechanics and Functionality

Old Age; Debility Clinical Trial

Official title:

Evaluation of the Effects of Coordination, Strength and Cardiorespiratory Endurance Training on Physical Fitness, Kinematic and Physiomechanics Parameters of Gait and Indicators Associated With the Quality of Life in Older People

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04348539
• Other study ID #: GaitOlderpeople
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: March 2022

Study information

• Verified date: April 2021
• Source: Federal University of Rio Grande do Sul
• Contact: Leonardo Alexandre Peyré-Tartaruga, PhD
• Phone: +555133085818
• Email: leonardo.tartaruga[@]ufrgs.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of study is to investigate gait in active elderly people regarding the kinematic parameters of gait, indicators of physical fitness and quality of life.

Description:

Objective: Evaluate and compare the effects of different types of training (balance training, strength training, cardiorespiratory endurance training); in the older people in the variables of physical fitness (dynamic balance, static balance, rate of strength production, flexibility and cardiorespiratory endurance), physiomechanics of gait (length and frequency of stride, time of contact and balance, energy conversion, mechanical work , transport cost, dynamic stability and mechanical efficiency of walking at different speeds), indicators associated with quality of life (depressive symptoms, health-related quality of life, fear of falling). Experimental Design: study experimental randomized. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Porto Alegre, Rio Grande do Sul, Brazil. Participants: older people from the community of both sexes, aged 60 or over, sedentary. Interventions: In this research, three groups of older people will receive intervention during 4 months of different types of training (balance training, strength training, cardiorespiratory endurance training); and a control group, who will receive educational lectures on health, walking and aging. The training programs will have a duration of 4 months and will be periodized so that the duration of the sessions is same between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by exercise time. The training programs will have a frequency of two sessions per week and a duration of 45 minutes. In order to evaluate the effects of the training, evaluations will be performed before and after the training period. Outcomes: the results will be related to the variables physical fitness, physiomechanics of gait, and indicators associated with quality of live. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05, and Bonferroni post-hoc to identify the differences between the means in all variables. Expected Results: The investigators believe that the better the level of physical fitness, the less likely it is that the elderly will enter into a frame of disability or fragility, especially improving physical fitness when compared to the control group. In addition, strategies to protect the elderly can be formulated through physical programs aimed at preventing the functional capacity and quality of life of the elderly. It is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social and environmental.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

Inclusion Criteria:

• volunteers
• aged over 60 years
• both sexes
• not performing regular physical activity with professional monitoring

Exclusion Criteria:

• not participate in all stages of the evaluation
• severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
• stroke or other associated neurological diseases; insanity;
• prostheses in the lower limbs;
• without ambulation conditions.

Related Conditions & MeSH terms

• Old Age; Debility

Intervention

Other:
• Balance training
32 sessions will be held twice a week, with each session taking an average of 45 minutes

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

GONÇALVES, A. K.; et al. Postural balance program: variables related to falls in elderly. Journal of Physical Education, v. 28, 2017

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic characteristics	Anamnesis with basic information about age, sex, marital status, education, occupation, housing, occurrence of diseases, use of medication.	Change from baseline at 16 weeks
Other	Cognitive function	Montreal Cognitive Assessment (MoCA), Portuguese version, evaluates 8 domains of cognitive functioning: attention and concentration, executive functions, memory, language, visuoconstructive abilities, conceptual thinking, calculations and guidance. The total score is 30 points; a value = 26 is considered normal.	Change from baseline at 16 weeks
Other	Lower limb flexibility	Lower limb flexibility: sit and reach test. The individual sits in the chair with his leg extended, slowly leans forward, trying to touch his toes. A measurement is made from the toes to the fingertips.	Change from baseline at 16 weeks
Primary	Dynamic Balance	Dynamic balance: Timed Get Up and Go test (distance of 3 meters), which give the time (seconds) that the individual takes to complete the path of the test as fast as possible (without running).	Change from baseline at 16 weeks
Primary	Strength	Lower limb strength: Test to get up and sit on the chair. The individual sits on the chair, with his arms crossed over his chest and at the signal starts the repetitions of getting up and sitting down for a total of 30 seconds. The number of repetitions the subject is able to perform is added.	Change from baseline at 16 weeks
Primary	Cardiorespiratory endurance	cardiorespiratory endurance: 6-minute test. The individual will walk in a 30 meters course for 6 minutes as fast as he can, without running, resulting in the distance covered in that interval.	Change from baseline at 16 weeks
Primary	Static balance	Static balance: force platform by means of the displacement rate of the centre of mass in the anteroposterior (Fx), medium-lateral (Fy) and vertical (Fz) axes. The older people must climb on the platform and unite their feet, keeping their gaze in a fixed linear point, the test will last for 30 seconds, it will be registered with the eyes open and closed	Change from baseline at 16 weeks
Secondary	Locomotor Rehabilitation Index	Locomotor Rehabilitation Index: method of determining how close is the self-selected walking speed compared to the Optimum Speed. The results is given in percent, and when Locomotor Rehabilitation Index value is closer to 100 percent, it indicates that the participants are closer to their theoretical optimal walking speed.	Change from baseline at 16 weeks
Secondary	Self-selected walking speed	Self-selected walking speed: This outcome will be measure in test of walking treadmill	Change from baseline at 16 weeks
Secondary	Anthropometric data - Body mass	Body mass: measure in kilograms before and after interventions.	Change from baseline at 16 weeks
Secondary	Depressive symptoms	Geriatric Depression Scale protocol: consists of 15 questions in which participants are asked to answer yes or no in reference to how they felt over the past week (for instance, "Do the patient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.	Change from baseline at 16 weeks
Secondary	Health-related quality of life: Medical Outcomes Study 36 - Item Short Form Health Survey	Medical Outcomes Study 36 - Item Short Form Health Survey: multidimensional questionnaire, formed by 36 items that encompass eight domains (functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health). The maximum score for each domain is 100, with the total sum being a maximum of 150, with zero being "worst" and 150 "best health status".	Change from baseline at 16 weeks
Secondary	Fear of falling	Falls Efficacy Scale - International: questions about the concern with the possibility of falling when performing 16 activities, with respective scores from one to four. The total score can vary from 16 (no concern) to 64 (extreme concern).	Change from baseline at 16 weeks
Secondary	Anthropometric data - Height	Height: measure in meters before and after interventions.	Change from baseline at 16 weeks
Secondary	Anthropometric data - Body Mass Index	Body Mass Index: Weight and height will be combined to report the body mass index in kg/m2.	Change from baseline at 16 weeks
Secondary	Spatial Parameter - Stride length	This outcome is measure by stride length in meters.	Change from baseline at 16 weeks
Secondary	Temporal Parameter - Swing time, contact time, time of balance	Swing time in seconds, contact time in seconds, time of balance in seconds. The percentage of contact time will be calculated to measure the duty factor in percentual. The swing and contact time in seconds will be aggregated to distance in meters to arrive at frequency (in Hetz).	Change from baseline at 16 weeks
Secondary	Parameters of Pendular Mechanism - Internal Work	The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The internal work is the mechanical energy fluctuations of the movement of limbs relative to the center of body mass (Wint, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.	Change from baseline at 16 weeks
Secondary	Parameters of Pendular Mechanism - external work	The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The external work is energy fluctuations of the center of body mass with respect to the external environment or surroundings (Wext, in Joules). This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.	Change from baseline at 16 weeks
Secondary	Parameters of Pendular Mechanism: total mechanical work	The transduction between the potential and kinetic mechanical energies of the center of body mass (called the "inverted pendulum" mechanism). The total mechanical work (Wtot =internal Work + External Work) produced by a body during activity. These outcomes are measured by composite for:(external, internal mechanical work, in Joules).	Change from baseline at 16 weeks
Secondary	Parameters of Pendular Mechanism: Recovery	The mechanical energy exchange of the center of mass is quantified by the calculation of the percentage of reconversion of mechanical energy, called Recovery (R), which counts the form that the mechanical energy is saved through the pendulum mechanism of the locomotion. This outcome will be measured through the registered image movement analysis using the three-dimensional motion analysis system VICON of the walking test on the treadmill.	Change from baseline at 16 weeks