Modified Otago Exercise Program on Balance Performance

March 11, 2022 updated by: Ho Yuk Ki Yorke, Tung Wah College

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hong Kong, Hong Kong
        • Tung Wah College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week before the Intervention
Falls Efficacy Scale International (FES-I)
Time Frame: 4 weeks after the start of the Intervention
4 weeks after the start of the Intervention
Falls Efficacy Scale International (FES-I)
Time Frame: 1 week after the completion of the Intervention
1 week after the completion of the Intervention
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
1 week before the Intervention, 4 weeks after the start of the Intervention
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
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
Time Frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention
4 weeks after the start of the Intervention, 1 week after the completion of the Intervention
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.
1 week before the Intervention
Functional Reach Test (FRT)
Time Frame: 4 weeks after the start of the Intervention
4 weeks after the start of the Intervention
Functional Reach Test (FRT)
Time Frame: 1 week after the completion of the Intervention
1 week after the completion of the Intervention
Change from Functional Reach Test (FRT) at 4 weeks
Time Frame: 1 week before the Intervention, 4 weeks after the start of the Intervention
1 week before the Intervention, 4 weeks after the start of the Intervention
Change from Functional Reach Test (FRT) at 8 weeks
Time Frame: 1 week before the Intervention, 1 week after the completion of the Intervention
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
Time Frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention
4 weeks after the start of the Intervention, 1 week after the completion of the Intervention
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.
1 week before the Intervention
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: 4 weeks after the start of the Intervention
4 weeks after the start of the Intervention
Mini Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: 1 week after the completion of the Intervention
1 week after the completion of the Intervention
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
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
Time Frame: 1 week before the Intervention, 1 week after the completion of the Intervention
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
Time Frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention
4 weeks after the start of the Intervention, 1 week after the completion of the Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week before the Intervention
Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol)
Time Frame: 4 weeks after the start of the Intervention
4 weeks after the start of the Intervention
Montreal Cognitive Assessment 5-minute protocol (Hong Kong version (HK-MoCA 5-min protocol)
Time Frame: 1 week after the completion of the Intervention
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
Time Frame: 1 week before the Intervention, 4 weeks after the start of the Intervention
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
Time Frame: 1 week before the Intervention, 1 week after the completion of the Intervention
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
Time Frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention
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)
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.
1 week before the Intervention
Physical Activity Scale for the Elderly - Chinese version (PASE-C)
Time Frame: 4 weeks after the start of the Intervention
4 weeks after the start of the Intervention
Physical Activity Scale for the Elderly - Chinese version (PASE-C)
Time Frame: 1 week after the completion of the Intervention
1 week after the completion of the Intervention
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
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
Time Frame: 1 week before the Intervention, 1 week after the completion of the Intervention
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
Time Frame: 4 weeks after the start of the Intervention, 1 week after the completion of the Intervention
4 weeks after the start of the Intervention, 1 week after the completion of the Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • MHS_SRC_2021_001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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