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Otago Home-Based Exercise Program in Community-Dwelling Older Women (METCOHEP Study)

I

Istanbul Arel University

Status

Terminated

Conditions

Risk of Falling
Balance Impairment

Treatments

Other: Balance Exercises
Other: Warm-up and Cool-down Program
Other: Otago Home Exercise Program
Other: Strengthening Exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT05931848
METCOHEP

Details and patient eligibility

About

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.

Full 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.

Enrollment

76 patients

Sex

Female

Ages

65+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

76 participants in 2 patient groups

Otago exercise group
Experimental group
Description:
The treatment 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 per group, under the supervision of a physiotherapist, in the Kadikoy Municipality Social Life Center, 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 non-supervised. 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 cool-down exercises.
Treatment:
Other: Otago Home Exercise Program
Other: Strengthening Exercises
Other: Warm-up and Cool-down Program
Other: Balance Exercises
control group
No Intervention group
Description:
The control group will not be included in any exercise program, 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 of intervention and control groups at the Kadıköy Municipality Social Life Center, where information about the factors that increase the risk of falling and house arrangements will be provided.

Trial contacts and locations

1

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Central trial contact

Nazlı Güngör, PT, MSc

Data sourced from clinicaltrials.gov

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