Clinical trial NCT05931848: Otago Home-Based Exercise Program in Community-Dwelling Older Women (METCOHEP Study)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Balance Impairment
Risk of Falling
Keywords: community-dwelling older women
Otago exercises
physical performance
balance
social participation
randomized controlled trial
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
name: Istanbul Aydın University
name: Kadikoy Municipality Social Life Center
First posted: 2023-07-05
Enrollment: 76
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: clinical research/randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 4-meter Walk Test
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: 5 Times Sit and Stand Test
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: One Foot Balance Test
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Tandem Balance Test
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Semi-tandem Balance Test
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Timed Get Up and Go Test
timeFrame: Change from initial of the treatment at 16 weeks of treatment
Secondary outcomes:
measure: Fear of falling (Activity-Specific Balance Confidence Scale)
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Hand grip strength (Jamar)
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Quadriceps isometric strength (Microfet)
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Fall rating (How many times have you fallen in the last 6 months? Have you been injured after falling?)
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Participation (World Health Organization Quality of Life Scale Elderly Module-WHOQL-OLD)
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Satisfaction with Life (Satisfaction with Life Scale)
timeFrame: Change from initial of the treatment at 16 weeks of treatment
measure: Loneliness (UCLA Loneliness Scale- Short Form)
timeFrame: Change from initial of the treatment at 16 weeks of treatment
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Arel University
state: Zeytinburnu
Study officials:
affiliation: Istanbul Arel University
name: Nazlı Güngör, PT, MSc
role: PRINCIPAL_INVESTIGATOR
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