Modified Otago Exercise Program on Balance Performance

Sponsor

Tung Wah College (Other)

Overall Status

Completed

CT.gov ID

NCT05290571

Collaborator

(none)

Enrollment

Location

Arms

1.1

Actual Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Aging Fall	Other: Modified Otago Exercise Program with music Other: Modified Otago Exercise Program	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 27, 2021

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group Intervention Group will be asked to follow the actions in the provided video. It lasts for approximately 30 minutes, with 5-minute warm-up and cool-down exercises respectively, a 4-minute song repeating for 4 times and a 1-minute rest in between each repetition. Videos, in the form of a YouTube link, will be distributed for the Intervention Group, as well as the leaflets.	Other: Modified Otago Exercise Program with music 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.
Active Comparator: Control Group Control Group will receive a leaflet on 10 actions extracted from mOEP, 2 actions from conventional OEP and 1 action from Mini-BESTest. The participants will perform 8-16 repetitions for each action, with 3-5 seconds of rest between actions.	Other: Modified Otago Exercise Program 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.

Arm

Intervention/Treatment

Experimental: Intervention Group

Intervention Group will be asked to follow the actions in the provided video. It lasts for approximately 30 minutes, with 5-minute warm-up and cool-down exercises respectively, a 4-minute song repeating for 4 times and a 1-minute rest in between each repetition. Videos, in the form of a YouTube link, will be distributed for the Intervention Group, as well as the leaflets.

Other: Modified Otago Exercise Program with music

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.

Active Comparator: Control Group

Control Group will receive a leaflet on 10 actions extracted from mOEP, 2 actions from conventional OEP and 1 action from Mini-BESTest. The participants will perform 8-16 repetitions for each action, with 3-5 seconds of rest between actions.

Other: Modified Otago Exercise Program

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.

Outcome Measures

Primary Outcome Measures

Falls Efficacy Scale International (FES-I) [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.
Falls Efficacy Scale International (FES-I) [4 weeks after the start of the Intervention]
Falls Efficacy Scale International (FES-I) [1 week after the completion of the Intervention]
Change from Falls Efficacy Scale International (FES-I) at 4 weeks [1 week before the Intervention, 4 weeks after the start of the Intervention]
Change from Falls Efficacy Scale International (FES-I) at 8 weeks [1 week before the Intervention, 1 week after the completion of the Intervention]
Change of Falls Efficacy Scale International (FES-I) between 4 weeks and 8 weeks [4 weeks after the start of the Intervention, 1 week after the completion of the Intervention]
Functional Reach Test (FRT) [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.
Functional Reach Test (FRT) [4 weeks after the start of the Intervention]
Functional Reach Test (FRT) [1 week after the completion of the Intervention]
Change from Functional Reach Test (FRT) at 4 weeks [1 week before the Intervention, 4 weeks after the start of the Intervention]
Change from Functional Reach Test (FRT) at 8 weeks [1 week before the Intervention, 1 week after the completion of the Intervention]
Change of Functional Reach Test (FRT) between 4 weeks and 8 weeks [4 weeks after the start of the Intervention, 1 week after the completion of the Intervention]
Mini Balance Evaluation Systems Test (Mini-BESTest) [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.
Mini Balance Evaluation Systems Test (Mini-BESTest) [4 weeks after the start of the Intervention]
Mini Balance Evaluation Systems Test (Mini-BESTest) [1 week after the completion of the Intervention]
Changes from Mini Balance Evaluation Systems Test (Mini-BESTest) at 4 weeks [1 week before the Intervention, 4 weeks after the start of the Intervention]
Changes from Mini Balance Evaluation Systems Test (Mini-BESTest) at 8 weeks [1 week before the Intervention, 1 week after the completion of the Intervention]
Changes of Mini Balance Evaluation Systems Test (Mini-BESTest) between 4 weeks and 8 weeks [4 weeks after the start of the Intervention, 1 week after the completion of the Intervention]

Secondary Outcome Measures

Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) [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.
Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) [4 weeks after the start of the Intervention]
Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) [1 week after the completion of the Intervention]
Changes from Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) at 4 weeks [1 week before the Intervention, 4 weeks after the start of the Intervention]
Changes from Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) at 8 weeks [1 week before the Intervention, 1 week after the completion of the Intervention]
Changes of Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol) between 4 weeks and 8 weeks [4 weeks after the start of the Intervention, 1 week after the completion of the Intervention]
Physical Activity Scale for the Elderly - Chinese version (PASE-C) [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.
Physical Activity Scale for the Elderly - Chinese version (PASE-C) [4 weeks after the start of the Intervention]
Physical Activity Scale for the Elderly - Chinese version (PASE-C) [1 week after the completion of the Intervention]
Changes from Physical Activity Scale for the Elderly - Chinese version (PASE-C) at 4 weeks [1 week before the Intervention, 4 weeks after the start of the Intervention]
Changes from Physical Activity Scale for the Elderly - Chinese version (PASE-C) at 8 weeks [1 week before the Intervention, 1 week after the completion of the Intervention]
Changes of Physical Activity Scale for the Elderly - Chinese version (PASE-C) between 4 weeks and 8 weeks [4 weeks after the start of the Intervention, 1 week after the completion of the Intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tung Wah College	Hong Kong		Hong Kong

Sponsors and Collaborators

Tung Wah College

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ho Yuk Ki Yorke, Student physiotherapist, Tung Wah College

ClinicalTrials.gov Identifier:

NCT05290571

Other Study ID Numbers:

MHS_SRC_2021_001

First Posted:

Mar 22, 2022

Last Update Posted:

Mar 22, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ho Yuk Ki Yorke, Student physiotherapist, Tung Wah College

Modified Otago Exercise Program

Modified Otago Exercise Program with music

Study Results

No Results Posted as of Mar 22, 2022