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

NCT05931848 | Terminated

• 1 other identifier: METCOHEP
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Balance Impairment; Risk of Falling

Keywords

community-dwelling older women; Otago exercises; physical performance; balance; social participation; randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• 4-meter Walk Test

  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.

  Change from initial of the treatment at 16 weeks of treatment

• 5 Times Sit and Stand Test

  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.

  Change from initial of the treatment at 16 weeks of treatment

• One Foot Balance Test

  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.

  Change from initial of the treatment at 16 weeks of treatment

• Tandem Balance Test

  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.

  Change from initial of the treatment at 16 weeks of treatment

• Semi-tandem Balance Test

  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.

  Change from initial of the treatment at 16 weeks of treatment

• Timed Get Up and Go Test

  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).

  Change from initial of the treatment at 16 weeks of treatment

Secondary Outcomes (7)

• Fear of falling (Activity-Specific Balance Confidence Scale)

  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

• Quadriceps isometric strength (Microfet)

  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 Arms (2)

Otago exercise group

EXPERIMENTAL

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.

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

control group

NO INTERVENTION

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.

Interventions

Warm-up and Cool-down Program OTHER

Each exercise in the warm-up and cool-down protocols consisting of active movements and static stretching exercises will be performed as 1 set and 10 repetitions. Active movements will be performed for 10 seconds. The detailed protocol is shown below. Neck flexion/extension/lateral flexion Circles made with the head chin-tuck Backward bilateral shoulder circumduction Shoulder external rotation with hands clasped at neck Circles with wrists clasped clockwise and counterclockwise Reciprocal upper extremity flexion-extension cat-camel Trunk lateral flexion with hands clasped overhead Trunk rotation in both directions Ankle dorsi/plantar flexion with knee extension Static Stretching Exercises Neck lateral flexor stretch Posterior capsule stretching Hands clasped trunk flexion lateral Trunk lateral flexion with hands clasped Trunk rotation in both directions Knee extensor and ankle plantar flexor stretching by reaching for toes

Otago exercise group

Strengthening Exercises OTHER

The progression of the strengthening program will be achieved by gradually changing the number of repetitions, sets, resistance and the number of exercises. 1-6 Weeks Upper extremity strengthening in unilateral PNF D2 pattern, Scapulothoracic strengthening with shoulder extension in elbow extension, Scapulothoracic strengthening with shoulder extension in elbow flexion, hip flexor strengthening, Hip abductor strengthening in knee flexion, when sit on the chair fingertip ups and downs 7-12 Weeks Added exercises Scapular adductor strengthening with shoulders in horizontal abduction position, Shoulder adductor strengthening in elbow extension with trunk lateral flexion in arms overhead position, hip abductor strengthening 13-16 Weeks Added exercises Shoulder abductor/flexor strengthening in the scapular plane, Elbow flexor strengthening, Upper extremity strengthening in unilateral PNF D2 pattern with trunk rotation, Taking a lateral step in a mini-squat position

Otago exercise group

Balance Exercises OTHER

Balance exercises will be applied following the strengthening exercises. The exercises will be gradually made more difficult. Participants will be encouraged to complete the balance exercises by standing next to the grab bar and with as little support as possible. 1-6. Week Rising and falling on the heels Hands at waist trunk extension hip abduction 6-9. Week Hip abduction and extension without lowering the foot to the ground, respectively 5 sec stop on tiptoe 5 seconds standing on one leg 10-12. Week Abduction, extension, and flexion of the hips without lowering the foot to the ground, respectively. 5 sec stop on tiptoe 10 sec stop on tiptoe 5 seconds standing on one leg 10 seconds standing on one leg 13-16. Week Abduction, extension, and flexion of the hips without lowering the foot to the ground, respectively. 10 sec stop on tiptoe 15 sec stop on tiptoe 10 seconds standing on one leg 15 seconds standing on one leg

Otago exercise group

Otago Home Exercise Program OTHER

The exercises included in the Otago Home Exercise Program will be taught to the participants after the group exercise session held at the Social Life Center. At the same time, home exercise training will be supported by brochures and videos. In addition to the exercises in the program, participants will be asked to do 30 minutes of moderate-intensity walking 2 days a week. Participants will be asked to record the exercises they did during the week in the exercise diary given to them. Balance Exercises 1. Knee bend (half squat) 2. Walking backwards 3. Walk and turn around 4. Sideways walking 5. Tandem stance 6. Tandem walking 7. Standing on one leg 8. Walking on the heel 9. Toe walking 10. Tandem walking backwards 11. Sit down 12. Going up and down stairs Strengthening Exercises 1\. Knee extension 2. Knee flexion 3. Hip abduction 4. Ankle plantar flexion 5. Ankle dorsiflexion

Otago exercise group

Eligibility Criteria

• Age: 65 Years+
• Gender Eligibility Details: Only community-dwelling older women will be recruited in this study.
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Arel University: lead
• Istanbul University - Cerrahpasa: collaborator
• Istanbul Aydın University: collaborator
• Kadikoy Municipality Social Life Center: collaborator

Study Sites (1)

Istanbul Arel University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (21)

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• Deones VL, Wiley SC, Worrell T. Assessment of quadriceps muscle performance by a hand-held dynamometer and an isokinetic dynamometer. J Orthop Sports Phys Ther. 1994 Dec;20(6):296-301. doi: 10.2519/jospt.1994.20.6.296.

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• Eckstrom E, Neukam S, Kalin L, Wright J. Physical Activity and Healthy Aging. Clin Geriatr Med. 2020 Nov;36(4):671-683. doi: 10.1016/j.cger.2020.06.009. Epub 2020 Aug 19.

  PMID: 33010902 RESULT

• Subias-Perie J, Navarrete-Villanueva D, Gomez-Cabello A, Vicente-Rodriguez G, Casajus JA. Health economic evaluation of exercise interventions in people over 60 years old: A systematic review. Exp Gerontol. 2022 May;161:111713. doi: 10.1016/j.exger.2022.111713. Epub 2022 Jan 29.

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• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

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• Karapolat H, Eyigor S, Kirazli Y, Celebisoy N, Bilgen C, Kirazli T. Reliability, validity, and sensitivity to change of Turkish Activities-specific Balance Confidence Scale in patients with unilateral peripheral vestibular disease. Int J Rehabil Res. 2010 Mar;33(1):12-8. doi: 10.1097/mrr.0b013e32832c0d72.

  PMID: 20183891 RESULT

• Kyrdalen IL, Moen K, Roysland AS, Helbostad JL. The Otago Exercise Program performed as group training versus home training in fall-prone older people: a randomized controlled Trial. Physiother Res Int. 2014 Jun;19(2):108-16. doi: 10.1002/pri.1571. Epub 2013 Dec 11.

  PMID: 24339273 RESULT

• Kocic M, Stojanovic Z, Nikolic D, Lazovic M, Grbic R, Dimitrijevic L, Milenkovic M. The effectiveness of group Otago exercise program on physical function in nursing home residents older than 65years: A randomized controlled trial. Arch Gerontol Geriatr. 2018 Mar-Apr;75:112-118. doi: 10.1016/j.archger.2017.12.001. Epub 2017 Dec 10.

  PMID: 29241091 RESULT

• Latham NK, Bennett DA, Stretton CM, Anderson CS. Systematic review of progressive resistance strength training in older adults. J Gerontol A Biol Sci Med Sci. 2004 Jan;59(1):48-61. doi: 10.1093/gerona/59.1.m48.

  PMID: 14718486 RESULT

• Lord SR, Delbaere K, Sturnieks DL. Aging. Handb Clin Neurol. 2018;159:157-171. doi: 10.1016/B978-0-444-63916-5.00010-0.

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• Makanae Y, Fujita S. Role of Exercise and Nutrition in the Prevention of Sarcopenia. J Nutr Sci Vitaminol (Tokyo). 2015;61 Suppl:S125-7. doi: 10.3177/jnsv.61.S125.

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• Michikawa T, Nishiwaki Y, Takebayashi T, Toyama Y. One-leg standing test for elderly populations. J Orthop Sci. 2009 Sep;14(5):675-85. doi: 10.1007/s00776-009-1371-6. Epub 2009 Oct 3.

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• Papa EV, Dong X, Hassan M. Resistance training for activity limitations in older adults with skeletal muscle function deficits: a systematic review. Clin Interv Aging. 2017 Jun 13;12:955-961. doi: 10.2147/CIA.S104674. eCollection 2017.

  PMID: 28670114 RESULT

• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

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• Rodrigues F, Domingos C, Monteiro D, Morouco P. A Review on Aging, Sarcopenia, Falls, and Resistance Training in Community-Dwelling Older Adults. Int J Environ Res Public Health. 2022 Jan 13;19(2):874. doi: 10.3390/ijerph19020874.

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• Shubert TE. Evidence-based exercise prescription for balance and falls prevention: a current review of the literature. J Geriatr Phys Ther. 2011 Jul-Sep;34(3):100-8. doi: 10.1519/JPT.0b013e31822938ac.

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• Thomas S, Mackintosh S, Halbert J. Does the 'Otago exercise programme' reduce mortality and falls in older adults?: a systematic review and meta-analysis. Age Ageing. 2010 Nov;39(6):681-7. doi: 10.1093/ageing/afq102. Epub 2010 Sep 4.

  PMID: 20817938 RESULT

• Unver B, Baris RH, Yuksel E, Cekmece S, Kalkan S, Karatosun V. Reliability of 4-meter and 10-meter walk tests after lower extremity surgery. Disabil Rehabil. 2017 Dec;39(25):2572-2576. doi: 10.1080/09638288.2016.1236153. Epub 2016 Oct 11.

  PMID: 27728985 RESULT

• Yang Y, Wang K, Liu H, Qu J, Wang Y, Chen P, Zhang T, Luo J. The impact of Otago exercise programme on the prevention of falls in older adult: A systematic review. Front Public Health. 2022 Oct 20;10:953593. doi: 10.3389/fpubh.2022.953593. eCollection 2022.

  PMID: 36339194 RESULT

MeSH Terms

Interventions

Warm-Up Exercise

Intervention Hierarchy (Ancestors)

Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Nazlı Güngör, PT, MSc

  Istanbul Arel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences

Model Details: clinical research/randomized controlled trial

Study Record Dates

• First Submitted: May 20, 2023
• First Posted: July 5, 2023
• Study Start: July 17, 2023
• Primary Completion: June 17, 2024
• Study Completion: June 17, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)