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NCT05931848: METCOHEP
Otago Home-Based Exercise Program in Community-Dwelling Older Women (METCOHEP Study)
NA trial testing Warm-up and Cool-down Program in Balance Impairment in 76 participants. Terminated before completion.
17 June 2024
Quick facts
| Lead sponsor | Istanbul Arel University |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 76 |
| Start date | 17 July 2023 |
| Primary completion | 17 June 2024 |
| Estimated completion | 17 June 2024 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Warm-up and Cool-down Program
- Strengthening Exercises
- Balance Exercises
- Otago Home Exercise Program
Conditions studied
- Balance Impairment — all drugs for Balance Impairment →
- Risk of Falling — all drugs for Risk of Falling →
Sponsor
Istanbul Arel University
Who can join
65 and older, female only, with Balance Impairment or Risk of Falling. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05931848 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istanbul Arel University
- Last refreshed: 1 May 2025
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