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Completed

NCT Number: NCT05290571

Modified Otago Exercise Program on Balance Performance

Fall is a common problem encountered by elderlies. In Hong Kong, the prevalence rate of falls among elderlies aged above 65 years old ranged from 18%-29%, standing at approximately one-fifths of the total elderly population. Falls pose huge threats to the physical and psychosocial health of the elderlies as they are often accompanied by serious injuries such as bone fracture and post-fall syndrome, decreased confidence in walking, and social exclusion.

Otago Exercise Program (OEP) was a tailor-made home-based fall prevention program of community-dwelling elderlies. It comprises of 3 main components: 5 lower limb strengthening, 12 balance retraining and walking exercises. Regarding on its effectiveness, multiple studies revealed that OEP and modified version of OEP (mOEP) brought significant improvements on perceived, static and dynamic balance, lower limb strength, quality of life and functional capacity of healthy elderlies and those with various health conditions such as chronic illnesses, osteoarthritis, stroke and hemiplegia.

The delivery method of OEP and mOEP has been limited to have elderlies following the instructions and illustrations of a printed booklet. Currently, there are only two proposed effective forms of mOEP: video-instructed and Exergames. Our study attempts to establish a new home-based exercise option incorporating mOEP with video, music and lyrics. It helps to increase the exercise motivation of elderlies, hence their physical performance.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tung Wah College

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elderlies in community dwellings aged 55 or above
  • Communicable & able to follow command
  • Self-reported sufficient visual & auditory ability to follow the actions in video
  • HK-MoCA 5-Min Protocol: No cognitive impairment
  • Able to access electronic devices, such as smartphones, computers, televisions with network, Digital Video Disc/Compact Disc player

Exclusion criteria

  • History of severe medical conditions that hinders physical ability, such as heart diseases and neurological disorders
  • History of lower limb fracture in recent 1 year
  • History of joint replacement and any cardio-thoracic surgeries
  • Self-reported visual & auditory impairment
  • Users of walking aids other than sticks, tripods or quadripods

Treatment and study plan

Modified Otago Exercise Program with music

Other

Our study attempts to establish a new home-based exercise option incorporating mOEP with video, music and lyrics. Our new approach shares the same aims with Exergames and video-supported methods - to increase the exercise motivation of elderlies, hence their physical performance. Based on the video-supported approach in one previous study, we add in the component of music therapy. Music-based exercise interventions could produce positive outcomes on both physical, such as gait, balance and fall risk and level of physical activities and psychological, including exercise adherence, perceived exertion, thus extending exercise duration. However, exact mechanisms have not been revealed and it may be limited by personal preferences on music. In our video, the music we chose is of brisk rhythm, slightly delightful melody and higher pitch, which all help to shape a cheerful and relaxing atmosphere for the elderlies.

Modified Otago Exercise Program

Other

Otago Exercise Program (OEP) was developed by Otago Medical School in New Zealand as a tailor-made home-based fall prevention program to improve the balance performance of community-dwelling elderlies over 1 year. It comprises of 3 main components: 5 lower limb strengthening, 12 balance retraining and walking exercises. In the original program, the intensity was set as moderate with up to 4 difficulty levels for strengthening and balance exercises, in terms of ankle cuff weights and number of repetitions, and level of support respectively. It also stated that the frequency was at least 3 times a week for the former two exercises and at least 2 times per week for walking exercises; while the total duration was expected to make up to an hour, including 30-minute walking exercises.

Primary outcomes

  1. Falls Efficacy Scale International (FES-I)

    Time frame: 1 week before the Intervention

    The Falls Efficacy Scale-International (FES-I) is a modified version of the FES, based on the perceptive feeling on fall risks of the participants. It is a 16-item questionnaire on a 4-point ordinal scale, emphasizing social and physical activities. The minimum and maximum score is 16 and 64 respectively while a lower score indicates higher confidence in one's balance ability.

  2. Falls Efficacy Scale International (FES-I)

    Time frame: 4 weeks after the start of the Intervention

  3. Falls Efficacy Scale International (FES-I)

    Time frame: 1 week after the completion of the Intervention

  4. Change from Falls Efficacy Scale International (FES-I) at 4 weeks

    Time frame: 1 week before the Intervention, 4 weeks after the start of the Intervention

  5. Change from Falls Efficacy Scale International (FES-I) at 8 weeks

    Time frame: 1 week before the Intervention, 1 week after the completion of the Intervention

  6. Change of Falls Efficacy Scale International (FES-I) between 4 weeks and 8 weeks

    Time frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention

  7. Functional Reach Test (FRT)

    Time frame: 1 week before the Intervention

    Functional Reach Test (FRT) is a common clinical outcome measure on dynamic standing balance. The participants were required to stand adjacent to a wall with a meter ruler fixed and to raise their preferred upper limb to the shoulder level. They were then instructed to reach as far as possible while maintaining their balance without moving both lower limbs for two trials, following one mock trial. The result recorded was the average distance from the reading of the tip of the third digit of the two trials. The longer the subject reaches, the better their dynamic balance.

  8. Functional Reach Test (FRT)

    Time frame: 4 weeks after the start of the Intervention

  9. Functional Reach Test (FRT)

    Time frame: 1 week after the completion of the Intervention

  10. Change from Functional Reach Test (FRT) at 4 weeks

    Time frame: 1 week before the Intervention, 4 weeks after the start of the Intervention

  11. Change from Functional Reach Test (FRT) at 8 weeks

    Time frame: 1 week before the Intervention, 1 week after the completion of the Intervention

  12. Change of Functional Reach Test (FRT) between 4 weeks and 8 weeks

    Time frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention

  13. Mini Balance Evaluation Systems Test (Mini-BESTest)

    Time frame: 1 week before the Intervention

    The Mini Balance Evaluation Systems Tests (Mini-BESTest) emphasizes on measuring dynamic balance, functional mobility and gait. The total score is 28 and encompasses 14 items, including anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. Subjects were asked to perform 14 actions such as sit to stand, tip-toe standing and single leg standing. A higher score indicates better balance ability of the subjects.

  14. Mini Balance Evaluation Systems Test (Mini-BESTest)

    Time frame: 4 weeks after the start of the Intervention

  15. Mini Balance Evaluation Systems Test (Mini-BESTest)

    Time frame: 1 week after the completion of the Intervention

  16. Changes from Mini Balance Evaluation Systems Test (Mini-BESTest) at 4 weeks

    Time frame: 1 week before the Intervention, 4 weeks after the start of the Intervention

  17. Changes from Mini Balance Evaluation Systems Test (Mini-BESTest) at 8 weeks

    Time frame: 1 week before the Intervention, 1 week after the completion of the Intervention

  18. Changes of Mini Balance Evaluation Systems Test (Mini-BESTest) between 4 weeks and 8 weeks

    Time frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention

Secondary outcomes

  1. Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol)

    Time frame: 1 week before the Intervention

    The Montreal Cognitive Assessment 5-minute protocol (MoCA 5-min protocol) version 20151030 is an abbreviated Chinese version of conventional MoCA, including 4 subtests. It emphasizes on the examination of 5 cognitive domains, which incorporates attention, verbal learning and memory, executive function and orientation. Participants were required to recall 5 words from the first trial, name animals for 1 minute, answer 6 items on date and geographic orientation and to remember the 5 words provided at the beginning of the test. The maximum score for the test is 30 while a higher outcome indicates better cognitive ability.

  2. Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol)

    Time frame: 4 weeks after the start of the Intervention

  3. Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol)

    Time frame: 1 week after the completion of the Intervention

  4. Changes from Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) at 4 weeks

    Time frame: 1 week before the Intervention, 4 weeks after the start of the Intervention

  5. Changes from Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) at 8 weeks

    Time frame: 1 week before the Intervention, 1 week after the completion of the Intervention

  6. Changes of Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) between 4 weeks and 8 weeks

    Time frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention

  7. Physical Activity Scale for the Elderly - Chinese version (PASE-C)

    Time frame: 1 week before the Intervention

    The Physical Activity Scale for the Elderly - Chinese version (PASE-C) is a brief assessment on the usual physical activity of the elderlies over a week. PASE scores are divided into three categories: sedentary, light, and moderate to intense. It examines the intensity of participation in leisure activities, sports, recreation, and muscle strengthening, and work. A higher score means that the subject adopts a more active lifestyle.

  8. Physical Activity Scale for the Elderly - Chinese version (PASE-C)

    Time frame: 4 weeks after the start of the Intervention

  9. Physical Activity Scale for the Elderly - Chinese version (PASE-C)

    Time frame: 1 week after the completion of the Intervention

  10. Changes from Physical Activity Scale for the Elderly - Chinese version (PASE-C) at 4 weeks

    Time frame: 1 week before the Intervention, 4 weeks after the start of the Intervention

  11. Changes from Physical Activity Scale for the Elderly - Chinese version (PASE-C) at 8 weeks

    Time frame: 1 week before the Intervention, 1 week after the completion of the Intervention

  12. Changes of Physical Activity Scale for the Elderly - Chinese version (PASE-C) between 4 weeks and 8 weeks

    Time frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention

Sponsors and collaborators

Lead sponsor

Tung Wah College

Other

Registry information

Official study title

The Effectiveness of Modified Otago Exercise Program on Balance Performance of Elderlies in Hong Kong

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2022
Registry last updated
Mar 22, 2022

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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