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Clinical Trials/NCT05931848
NCT05931848
Terminated
Not Applicable

Effects of Group Based Multimodal Exercise Training Combined With Otago Home-Based Exercise Program on Physical Performance, Balance, and Social Participation in Community-Dwelling Older Women (METCOHEP Study)

Istanbul Arel University1 site in 1 country76 target enrollmentJuly 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Balance Impairment
Sponsor
Istanbul Arel University
Enrollment
76
Locations
1
Primary Endpoint
Tandem Balance Test
Status
Terminated
Last Updated
last year

Overview

Brief Summary

The aim of this study is to investigate the effect of group-based multimodal exercise training combined with Otago home-based exercise program on physical performance, balance and social participation in community-dwelling older women.

Hypotheses:

H0: Group-based multimodal exercise training combined with Otago home-based exercise program in community-dwelling older women has no effect on physical performance, balance and social participation.

H1: Group-based multimodal exercise training combined with Otago home-based exercise program in community-dwelling older women has positive effects on physical performance, balance and social participation.

Within the scope of the study, the exercise program will be carried out 3 days a week and for 16 weeks;

  • One day a week under the supervision of a physiotherapist, in the form of group exercise training in the center
  • Two days a week, the Otago Home Exercise Program will be conducted non-supervised at the participants' homes.

Within the scope of group exercise training, it is planned to implement a program of approximately 45-60 minutes, including warm-up, strengthening, balance and cool-down exercises. The control group will not be included in any exercise application, if they wish, they can be recruited in the same program after 16 weeks. In addition, all participants will be given a training in which they will be informed about the risk of falling. There will be 2 evaluations at the beginning of the study and at the end of the 16-week program. Within the scope of the study, participants' balance, walking speed, muscle strength, fear of falling, participation, life satisfaction and loneliness parameters will be evaluated.

At the end of this study, the change in balance, walking speed, muscle strength, fear of falling, participation, life satisfaction and loneliness in community-dwelling older women will be evaluated by applying the group-based multimodal exercise training combined with Otago home-based exercise program including strengthening and balance exercises. The original aspect of this study is the presentation of the results to be obtained by combining the effect of group exercise that creates opportunities for social interaction with the structure of the home based Otago exercise program that ensures its sustainability in the home environment.

Detailed Description

Within the scope of the program, which will last for 16 weeks, 3 days a week, a total of 48 sessions will be held. The program will be held one day a week with a maximum of 8 participants, under the supervision of a physiotherapist, in the Kadıköy Municipality Social Life House, in the form of group exercise training, and two days a week at the participants' homes, with the implementation of the Otago Home Exercise Program unattended. Participants will be informed that the program should be implemented on non-consecutive days. All warm-up and strengthening exercises will be applied in combination with breathing. While the home exercise program is being taught to the patients, information will be given about the situations where the exercise is contraindicated and should be stopped. Within the scope of group exercise training, it is planned to implement a structured program of approximately 45-60 minutes, including warm-up, strengthening, balance and cooling exercises. The control group will not be included in any exercise application, and they will be informed that they can participate in the same program after 16 weeks if they prefer. At the same time, a one-session training will be given to all participants in the application and control groups at the Kadıköy Municipality Social Life House, where information about the factors that increase the risk of falling and house arrangements will be provided.

Registry
clinicaltrials.gov
Start Date
July 17, 2023
End Date
June 17, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Istanbul Arel University
Responsible Party
Principal Investigator
Principal Investigator

NAZLI GÜNGÖR

Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences

Istanbul Arel University

Eligibility Criteria

Inclusion Criteria

  • 65 years and older and female gender,
  • No cognitive deficit (Montreal Cognitive Assessment (MoCA) score above 21),
  • Able to walk without using assistive devices
  • those people who can speak and understand Turkish is planned to include in the study.

Exclusion Criteria

  • Patients with unstable cardiovascular disease (unstable angina pectoris, critical aortic stenosis, uncontrolled atrial or ventricular arrhythmia, 3rd degree atrioventricular block, etc.)
  • Having a history of fracture in the upper and/or lower extremity up to 1 year ago,
  • Neurological, pulmonary, cardiovascular, rheumatological and musculoskeletal diseases that prevent participation in exercise,
  • Have a clinical diagnosis that will affect the nervous system, vestibular system or visual balance
  • Those with malignancies affecting the lower extremity,
  • Those who cannot communicate
  • people who participate in physical exercise programs such as pilates, tai-chi, fitness for more than 60 minutes a week is planned not to include in the study.

Outcomes

Primary Outcomes

Tandem Balance Test

Time Frame: Change from initial of the treatment at 16 weeks of treatment

Tandem Balance Test: The elder will be asked to stand for 10 seconds with one foot in front of the other. Right leg first and left leg first will be measured separately. This measurement will be utilized to obtain Brief Physical Performance Scale scoring.

Semi-tandem Balance Test

Time Frame: Change from initial of the treatment at 16 weeks of treatment

Semi-Tandem Balance Test: The elder will be asked to stand for 10 seconds with the heel of one foot beside the other's big toe. Right leg first and the left leg first will be measured separately. This measurement will be utilized to obtain Brief Physical Performance Scale scoring.

Timed Get Up and Go Test

Time Frame: Change from initial of the treatment at 16 weeks of treatment

Timed Get Up and Go Test In the timed get up and go test, a point was marked 3 m from the chair where the participant was sitting. The participant will be asked to get up from the chair and walk 3 m and return to sit on the chair again, and the time to complete the test will be measured with a stopwatch. Times of fourteen seconds or more will be considered as a high risk of falling (Podsiadlo, 1991).

4-meter Walk Test

Time Frame: Change from initial of the treatment at 16 weeks of treatment

4 meter Walk Test: The person will be asked to walk the 4-meter distance at his normal speed as in his daily life, and the walking time of the 4-meter distance will be recorded in seconds. This measurement will be utilized to obtain Brief Physical Performance Scale scoring.

5 Times Sit and Stand Test

Time Frame: Change from initial of the treatment at 16 weeks of treatment

5 times sit and stand test: The patient sits with his arms crossed over his shoulders and his back against a chair. With the "Start" command, the patient is expected to stand up and sit up quickly five times from the standard chair. The elapsed time will be measured with a stopwatch and recorded in seconds. This measurement will be utilized to obtain Brief Physical Performance Scale scoring.

One Foot Balance Test

Time Frame: Change from initial of the treatment at 16 weeks of treatment

Single Leg Balance Test: the participant will be asked to stand on one leg while the knee is in 90° flexion. The stopwatch will be recorded time in seconds. The test will be terminated if the elder's upper foot touches the ground. Separate measurements are made for both extremities. This measurement will be utilized to obtain Brief Physical Performance Scale scoring.

Secondary Outcomes

  • Fear of falling (Activity-Specific Balance Confidence Scale)(Change from initial of the treatment at 16 weeks of treatment)
  • Quadriceps isometric strength (Microfet)(Change from initial of the treatment at 16 weeks of treatment)
  • Hand grip strength (Jamar)(Change from initial of the treatment at 16 weeks of treatment)
  • Loneliness (UCLA Loneliness Scale- Short Form)(Change from initial of the treatment at 16 weeks of treatment)
  • Satisfaction with Life (Satisfaction with Life Scale)(Change from initial of the treatment at 16 weeks of treatment)
  • Fall rating (How many times have you fallen in the last 6 months? Have you been injured after falling?)(Change from initial of the treatment at 16 weeks of treatment)
  • Participation (World Health Organization Quality of Life Scale Elderly Module-WHOQL-OLD)(Change from initial of the treatment at 16 weeks of treatment)

Study Sites (1)

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