Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
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.
Query!
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
Query!
Secondary ID [1]
282922
0
Nil
Query!
Universal Trial Number (UTN)
Nil
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Mild balance impairment during turning.
289736
0
Query!
Condition category
Condition code
Physical Medicine / Rehabilitation
290066
290066
0
0
Query!
Other physical medicine / rehabilitation
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
287621
0
Prevention
Query!
Intervention code [2]
287647
0
Treatment: Other
Query!
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.
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
290118
0
Query!
Timepoint [1]
290118
0
At baseline assessment (one week prior start of intervention and within a week after 16 weeks intervention completion.
Query!
Primary outcome [2]
290119
0
Timed Up and Go Test
Query!
Assessment method [2]
290119
0
Query!
Timepoint [2]
290119
0
At baseline assessment (one week prior start of intervention) and within a week after 16 weeks intervention completion.
Query!
Secondary outcome [1]
303970
0
Adherence to exercise program as assessed using an exercise diary.
Query!
Assessment method [1]
303970
0
Query!
Timepoint [1]
303970
0
At 16 weeks, after completion of the intervention.
Query!
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
Query!
Minimum age
50
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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).
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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).
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers table
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people assessing the outcomes
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Safety/efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
15/06/2013
Query!
Actual
20/06/2013
Query!
Date of last participant enrolment
Anticipated
20/12/2013
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
68
Query!
Accrual to date
Query!
Final
Query!
Recruitment outside Australia
Country [1]
5252
0
Malaysia
Query!
State/province [1]
5252
0
Selangor
Query!
Funding & Sponsors
Funding source category [1]
287697
0
University
Query!
Name [1]
287697
0
University Putra Malaysia
Query!
Address [1]
287697
0
Academic Training Section
Registrar Office,
University Putra Malaysia,
43400 Serdang,
Selangor.
Query!
Country [1]
287697
0
Malaysia
Query!
Primary sponsor type
University
Query!
Name
School of Physiotherapy, Curtin University
Query!
Address
School of Physiotherapy
Curtin University,
Kent Street
Perth Western Australia, 6102
Query!
Country
Australia
Query!
Secondary sponsor category [1]
286430
0
University
Query!
Name [1]
286430
0
Institute of Gerontology, University Putra Malaysia
Query!
Address [1]
286430
0
University Putra Malaysia
43400 Serdang,
Selangor
Query!
Country [1]
286430
0
Malaysia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289657
0
Faculty of Health Ethic Committee (FHEC)
Query!
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
Query!
Ethics committee country [1]
289657
0
Australia
Query!
Date submitted for ethics approval [1]
289657
0
Query!
Approval date [1]
289657
0
30/05/2013
Query!
Ethics approval number [1]
289657
0
PT231/2013
Query!
Ethics committee name [2]
289658
0
University Research Ethic Committee (JKEUPM)
Query!
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
Query!
Ethics committee country [2]
289658
0
Malaysia
Query!
Date submitted for ethics approval [2]
289658
0
Query!
Approval date [2]
289658
0
10/05/2013
Query!
Ethics approval number [2]
289658
0
IG-Curtin April (13) 04
Query!
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
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
41826
0
Prof Keith D.Hill
Query!
Address
41826
0
School of Physiotherapy
Curtin University,
Kent Street,
Perth, Western Australia 6102
Query!
Country
41826
0
Australia
Query!
Phone
41826
0
+61892663618
Query!
Fax
41826
0
+61892663699
Query!
Email
41826
0
[email protected]
Query!
Contact person for public queries
Name
41827
0
Ms Asmidawati Ashari
Query!
Address
41827
0
Institute of Gerontology
University Putra Malaysia
43400 Serdang
Selangor
Query!
Country
41827
0
Malaysia
Query!
Phone
41827
0
+60389472735
Query!
Fax
41827
0
+60389472744
Query!
Email
41827
0
[email protected]
Query!
Contact person for scientific queries
Name
41828
0
Prof Keith D.Hill
Query!
Address
41828
0
School of Physiotherapy
Curtin University,
Kent Street,
Perth, Western Australia 6102
Query!
Country
41828
0
Australia
Query!
Phone
41828
0
+61892663618
Query!
Fax
41828
0
+61892663699
Query!
Email
41828
0
[email protected]
Query!
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.
Download to PDF