Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000855729
Ethics application status
Approved
Date submitted
30/07/2013
Date registered
2/08/2013
Date last updated
2/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fall risk assessment and effectiveness of home based exercise on turning ability, balance and functional mobility among older Malaysian adults aged 50 years and above.
Scientific title
Individualised home based exercise to improve turning ability and functional balance performance for community dwelling older adults with mild balance impairment: A randomised trial
Secondary ID [1] 282922 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild balance impairment during turning. 289736 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290066 290066 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will participate in a tailored (individualised) home based balance exercise program. This exercise program is based on The Otago Program, a program shown to be effective in improving general balance in older people with mild to moderate balance dysfunction (Campbell, 1997), but will include additional exercises selected to improve aspects of balance impairment associated with impaired turning performance. Participants in the home based exercise group will be provided with an individualized set of exercises based on assessment findings of areas of impairment. Approximately 1-2 of the 6-8 exercises prescribed will be selected to improve turning ability. The home based exercise program is expected to take 20-30 minutes per session on average, including rests. Participants will be encouraged to continue the exercise program at least four times a week for 16 weeks. The dosage is consistent with recommendations from a meta-analysis of exercise interventions in reducing falls (Sherrington et al., 2008, 2011). At initial session, participant will be received a detailed description of exercise program,exercise booklet and explanation of the purpose of each exercise from the researcher, which will take approximately 60 to 90 minutes. Participants in the exercise intervention will return to the assessment laboratory for three occasions in the 16 week duration (one visit after 3, 6 and 9 weeks) to review the exercise program, modify exercises if required, and motivate the participant to persist with the exercises which will take approximately 45 to 60 minutes per session. Participants will receive 4 phone calls ( 5 to 10 minutes duration per call) over the 16 week period between these laboratory visit from researcher to further encourage participants to continue with the exercise program, and answer questions about the program. Strategies to support adherence in this study include provision of the exercise booklet, review and feedback on performance at the three visits during the 16 week program, encouragement at phone calls between the visits, and having participants complete and return an exercise diary.
Intervention code [1] 287621 0
Prevention
Intervention code [2] 287647 0
Treatment: Other
Comparator / control treatment
The control group will continue their normal activities, and will receive the same number and timing of follow up social phone calls as the phone calls received by the exercise group (n =4). Control participants will also be asked to provide details of any falls in the preceding 3 weeks at these phone calls.
Control group
Active

Outcomes
Primary outcome [1] 290118 0
The degree of sway during Step Quick Turn Test as assessed by Laboratory Measurement of Balance using Neurocom Balance Masters Force Platform.
Timepoint [1] 290118 0
At baseline assessment (one week prior start of intervention and within a week after 16 weeks intervention completion.
Primary outcome [2] 290119 0
Timed Up and Go Test
Timepoint [2] 290119 0
At baseline assessment (one week prior start of intervention) and within a week after 16 weeks intervention completion.
Secondary outcome [1] 303970 0
Adherence to exercise program as assessed using an exercise diary.
Timepoint [1] 303970 0
At 16 weeks, after completion of the intervention.

Eligibility
Key inclusion criteria
i) Aged 50 years and above;ii) able to tolerate standing and walking independently for at least six minutes;iii) Identified as unsteady on turning using the Neurocom Balance Masters Step quick turn test;iv) Community dwelling
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) severe clinical or musculoskeletal impairments (eg previous fractures) affecting mobility; ii) visual or auditory impairments which cannot be corrected; iii)history of stroke, Parkinson’s disease, cardiac problems, or transient ischaemic attacks; iv) aged less than 50 years old; v) uses a walking frame, crutches or other bilateral support gait aids for walking in the community; or not community ambulant (not able to walk outdoors away from home independently); vi) institutionalized (living in residential care).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited through public promotion of the study, including via presentations and information fliers to older adult organisations such as University of the Third Age. Potential participants will be screened on a single occasion to determine presence of balance impairment on the selected balance task (turning), and if performance is outside of normal limits, they will be eligible for participation in the study. Group allocation will be concealed by using sealed opaque envelopes, and will be opened following the baseline assessment being completed. Participants will be randomised to a control group (maintain usual activity) or a home exercise (intervention) group (randomisation sequence will be generated by a computerised random numbers table). The researcher opening the envelope with group allocation will not have access to the results of the baseline assessment (concealed allocation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will include baseline and post intervention measures, which will be reported as means (m) +/- standard deviations (SD). Data will be analysed on an intention to treat basis. Missing data (due to loss to follow up) will be imputed using the last value carried forwards method. Change in the selected primary outcome measure and secondary outcomes will be evaluated using two way Repeated Measures ANOVA to determine group main effect, time main effect, and interaction effect between group and time. Level of significance will be set at P < 0.05. Participants in the exercise group will be grouped according to high adherence (above median adherence for the full group) and low adherence (equal or below median adherence level). Repeated measures ANOVA will be used to determine whether there is a difference in the primary and secondary balance measures between the high adherence and low adherence group.
Power analysis were performed for the primary outcome measure (180 degree Step Quick Turn test on the Neurocom Balance Master), using the mean score for the Step Quick Turn test (sway-degs-1) results from a previous exercise intervention trial of older people with mild balance impairments (Yang et al., 2012). It was estimated that 34 participants per group (68 participants in total) would be required, allowing for an anticipated 20% dropout rate, at least 80% power to detect a 15% improvement in the Step Quick Turn test using the turn sway measure on the Neurocom Balance Master long-plate (degs-1) (assuming 50% standard deviation improvement [sd=10.2, effect size=0.5] at p < 0.05 (two-tailed). Power analysis based on results reported in the Yang et al (2012) study, and with the same assumptions of improvement in the exercise group as described for the Step Quick Turn test, indicate this sample size should also be adequate for other secondary outcome measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/06/2013
Actual
20/06/2013
Date of last participant enrolment
Anticipated
20/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 5252 0
Malaysia
State/province [1] 5252 0
Selangor

Funding & Sponsors
Funding source category [1] 287697 0
University
Name [1] 287697 0
University Putra Malaysia
Country [1] 287697 0
Malaysia
Primary sponsor type
University
Name
School of Physiotherapy, Curtin University
Address
School of Physiotherapy
Curtin University,
Kent Street
Perth Western Australia, 6102
Country
Australia
Secondary sponsor category [1] 286430 0
University
Name [1] 286430 0
Institute of Gerontology, University Putra Malaysia
Address [1] 286430 0
University Putra Malaysia
43400 Serdang,
Selangor
Country [1] 286430 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289657 0
Faculty of Health Ethic Committee (FHEC)
Ethics committee address [1] 289657 0
Human Research Ethic Committee
Office of Research and Development,
Curtin University of Technology
GPO Box U1987,
Perth , Western Australia 6845
Ethics committee country [1] 289657 0
Australia
Date submitted for ethics approval [1] 289657 0
Approval date [1] 289657 0
30/05/2013
Ethics approval number [1] 289657 0
PT231/2013
Ethics committee name [2] 289658 0
University Research Ethic Committee (JKEUPM)
Ethics committee address [2] 289658 0
University Research Ethic Committee (JKEUPM,
Office of the Deputy Vice Chancellor (Research and Innovation)
University Putra Malaysia,
Serdang, 43400 Selangor
Ethics committee country [2] 289658 0
Malaysia
Date submitted for ethics approval [2] 289658 0
Approval date [2] 289658 0
10/05/2013
Ethics approval number [2] 289658 0
IG-Curtin April (13) 04

Summary
Brief summary
The present study aims to provide a basis for planning falls prevention interventions of relevance to specific identified risks in the Malaysian population. This study will be a randomised controlled trial that will investigate the effectiveness of a 16 weeks home based exercise approach in improving turning performance in the sample of community dwelling Malaysians aged 50 years and above participating in study. The results of this study will assist health practitioners in Malaysia to improve assessment of falls risk factors, especially balance impairment of older Malaysians, and to improve management of older Malaysians with identified balance impairment. The hypothesis of this study is that there will be a significant improvement in turning balance performance in a group undertaking a 16 week progressive home based exercise program targeting turning performance compared to a control group continuing with usual activity
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41826 0
Prof Keith D.Hill
Address 41826 0
School of Physiotherapy
Curtin University,
Kent Street,
Perth, Western Australia 6102
Country 41826 0
Australia
Phone 41826 0
+61892663618
Fax 41826 0
+61892663699
Email 41826 0
[email protected]
Contact person for public queries
Name 41827 0
Asmidawati Ashari
Address 41827 0
Institute of Gerontology
University Putra Malaysia
43400 Serdang
Selangor
Country 41827 0
Malaysia
Phone 41827 0
+60389472735
Fax 41827 0
+60389472744
Email 41827 0
[email protected]
Contact person for scientific queries
Name 41828 0
Keith D.Hill
Address 41828 0
School of Physiotherapy
Curtin University,
Kent Street,
Perth, Western Australia 6102
Country 41828 0
Australia
Phone 41828 0
+61892663618
Fax 41828 0
+61892663699
Email 41828 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.