Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000472673
Ethics application status
Approved
Date submitted
15/09/2005
Date registered
23/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The health-related benefits of country line dancing in community-dwelling older women with functional impairment: A double-blind placebo controlled clinical trial
Scientific title
The health-related benefits of country line dancing in community-dwelling older women with functional impairment: A double-blind placebo controlled clinical trial
Universal Trial Number (UTN)
Trial acronym
Health benefits of CLD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ageing 591 0
Functional impairment 592 0
Condition category
Condition code
Other 665 665 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, randomised placebo-controlled trial. Participants will be randomised to country line dancing or stretching. Participants will not be informed of the investigators hypotheses regarding which of the 2 forms of interventions will be more effective. A blinded assessor will conduct all outcome assessments.The literature indicates to have an effect size of 0.67-1.08, with alpha set at 0.05 and power of 0.8, the sample size should be between 30-72. We will require 80 subjects in anticipation of a dropout rate of 10% over 6 months of intervention. Volunteers who meet the inclusion criteria will be randomised to stretching and country line dancing groups. 40 in the stretching group will attend stretching for 6 months, twice per week, and 40 in line dancing group will be doing line dancing for 2 times per week each session 1 hour for 6 months.
Intervention code [1] 613 0
Lifestyle
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 791 0
Overall exercise capacity using the 6-minute walk test
Timepoint [1] 791 0
Before intervention and within 2 weeks post intervention.
Secondary outcome [1] 1600 0
Muscle strength (using 1-repitition-maximum with free weight).
Timepoint [1] 1600 0
Before intervention and within 2 weeks post intervention.
Secondary outcome [2] 1601 0
Flexibility (using goniometry and hand-held dynamometer for passive joint ranges).
Timepoint [2] 1601 0
Before intervention and within 2 weeks post intervention.
Secondary outcome [3] 1602 0
Lower limb function (Short Physical Performance Battery).
Timepoint [3] 1602 0
Before intervention and within 2 weeks post intervention.
Secondary outcome [4] 1603 0
Static and dynamic balance (tandem and one-legged stance times, and tandem walk forward test respectively).
Timepoint [4] 1603 0
Before intervention and within 2 weeks post intervention.
Secondary outcome [5] 1604 0
Quality of life (SF-36 health survey).
Timepoint [5] 1604 0
Before intervention and within 2 weeks post intervention.
Secondary outcome [6] 1605 0
Instrumental Activity of Daily Living (Functional Status survey).
Timepoint [6] 1605 0
Before intervention and within 2 weeks post intervention.
Secondary outcome [7] 1606 0
Self efficacy (Self Efficacy for Exercise).
Timepoint [7] 1606 0
Before intervention and within 2 weeks post intervention.
Secondary outcome [8] 1607 0
Depressive symptoms (Geriatric Depression scale).
Timepoint [8] 1607 0
Before intervention and within 2 weeks post intervention.

Eligibility
Key inclusion criteria
Community residents, self reported disability or limitation in daily function, ambulating without use of assistive device, no medical conditions or physical or cognitive limitations that would prohibit them from understanding instructions and participating in country line dancing and stretching safely, has no pain or discomfort experience during one hour of weight bearing, and do not exercise on a regular basis (ie < twice per week exercise).
Minimum age
65 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Are those who experienced pain or discomfort during 1-hour exercise or weight-bearing activities, presents with medical conditions that may prohibit them from understanding instructions and participating in country line dancing and stretching safely, and regular exercises > once per week.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will not be informed of the investigators hypotheses regarding which of the 2 forms of interventions will be more effective. A blinded assessor will conduct all outcome assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a program by Boston University, www.randomization.com, having blocks of 6
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 226 0
Singapore
State/province [1] 226 0

Funding & Sponsors
Funding source category [1] 733 0
Government body
Name [1] 733 0
National Medical Research Council (Singapore)
Country [1] 733 0
Singapore
Funding source category [2] 734 0
University
Name [2] 734 0
postgraduate research fund from University of Sydney
Country [2] 734 0
Australia
Primary sponsor type
Name
NIL
Address
Country
Secondary sponsor category [1] 608 0
None
Name [1] 608 0
NIL
Address [1] 608 0
Country [1] 608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1928 0
University of Sydney Ethics Committee
Ethics committee address [1] 1928 0
Ethics committee country [1] 1928 0
Australia
Date submitted for ethics approval [1] 1928 0
Approval date [1] 1928 0
Ethics approval number [1] 1928 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35203 0
Address 35203 0
Country 35203 0
Phone 35203 0
Fax 35203 0
Email 35203 0
Contact person for public queries
Name 9802 0
Mina LEE
Address 9802 0
School of Health Sciences
Nanyang Polytechnic
180 Ang Mo Kio Ave 8
569830
Country 9802 0
Singapore
Phone 9802 0
+65 65501343
Fax 9802 0
+65 64596811
Email 9802 0
[email protected]
Contact person for scientific queries
Name 730 0
Mina LEE
Address 730 0
School of Health Sciences
Nanyang Polytechnic
180 Ang Mo Kio Ave 8
569830
Country 730 0
Singapore
Phone 730 0
+65 65501343
Fax 730 0
+65 64596811
Email 730 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.