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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02621697
Other study ID # UFTM 2015
Secondary ID
Status Completed
Phase N/A
First received August 14, 2015
Last updated December 2, 2015
Start date February 2014
Est. completion date July 2015

Study information

Verified date December 2015
Source Universidade Federal do Triangulo Mineiro
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

Objectives: To evaluate the effects of eight weeks of cognitive motor training (dual task) in the risk of falls, balance, independence in basic activities of daily living (BADL) and handgrip in institutionalized elderly.

Methods: The sample was divided in two groups: double task group (DTG), consists of five elderly, undergoing a training consists of motor and cognitive activities and control group (CG) consists of four seniors who underwent conventional kinesiotherapeutic training, based on global stretching and strengthening exercises, both held in 16 sessions.


Description:

Experimental, prospective and quantitative study, whose sample was selected for convenience in a long-term care institution for the elderly (LTCF) in the city of Uberaba - MG. The volunteers were divided into two groups, named dual task group (DTG) consists of five seniors, and control group (CG) consists of four elderly. All participants of both groups answered a questionnaire with sociodemographic and economic characteristics of the sample. Participants underwent a pre- and post evaluation containing vital signs parameters (blood pressure, respiratory rate and heart rate), anthropometric data (weight and height) and different tests to evaluate the balance, functional mobility, risk of falls, muscle strength and independence to carry out basic activities of daily living. The performed tests were Timed Up and Go (TUG) conventional, motor TUG and TUG cognitive, beyond Romberg test and Sensitized Romberg, Berg Balance Scale, and modified Katz scale (with maintenance of the six original activities of the scale, but with simulation to the performance of each task, measuring the spent time).


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date July 2015
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Years to 80 Years
Eligibility Inclusion criteria:

- individuals over the age of 60,

- minimum score of 18 points on the Mini-Mental State Examination (MMSE),

- individuals classified as sedentary according the International Physical Activity Questionnaire (short version IPAQ-),

- literate and visual acuity preserved or corrected.

Exclusion criteria:

- Individuals unable to remain standing upright

- individuals dependent from auxiliary device to walk

- those who performed another type of physical therapy intervention concomitantly

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Cognitive motor training
Initially an intervention consisting of double duty activities (motor-cognitive) and the control group will be subjected to a conventional treatment based on stretching and strengthening will be held.
kinesiotherapeutic conventional treatment
Standardized global stretching and strengthening with squat exercise, plantar flexion in foot and elbow flexion supporting body weight in the hands arranged on the wall

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Federal do Triangulo Mineiro

Outcome

Type Measure Description Time frame Safety issue
Primary Risk of falls Measured by the following tests: TUG, motor TUG, cognitive TUG, Romberg and sensitized Romberg (all measured in seconds) 8 weeks of training Yes
Secondary Independence to carry out basic activities of daily living Through the modified Katz scale: the simulation of the activities originally present in the Katz scale was performed by the participants, and the time taken to their execution was recorded. 8 weeks of training Yes
Secondary Muscle strength Through dynamometry 8 weeks of training Yes
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