Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000772246
Ethics application status
Approved
Date submitted
4/09/2009
Date registered
7/09/2009
Date last updated
9/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Pilates as a catalyst for engaging the aging
Scientific title
Benefit to postural balance using Clinical Pilates exercises for healthy older adults
Secondary ID [1] 251955 0
ACTRN12609000772246
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural Balance 243660 0
Fall Risk 243662 0
Cardiovascular Disease Risk 243664 0
Mental Health 243665 0
Lung Function Testing 279323 0
Condition category
Condition code
Musculoskeletal 239930 239930 0 0
Other muscular and skeletal disorders
Cardiovascular 239934 239934 0 0
Coronary heart disease
Mental Health 239935 239935 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 Sessions per week in clinic and one home based session for 6 weeks for 45-60 minutes of Clinical Pilates exercise (ie 18 sessions in all). Clinic sessions using a Pilates reformer and mat work work will be supervised by a qualified physiotherapist. Four participants per session will allow individualisation of the exercise program, which will target leg strength and balance. The home program will consist of similar exercises to the mat work. Four weeks of washout will be undertaken before these participants will embark upon the contorl arm of the study.
Intervention code [1] 241215 0
Treatment: Other
Comparator / control treatment
This first arm of this study included a control group that consisted of normal activity for six weeks, wash out for four weeks, and then participation in the exercise intervention for six weeks. The next stage of recruitment will be for a RCT. It will run for ten weeks, during which the control group will be requested to maintain usual activity. Participants allocated to the control group will have the opportunity to participate in the treatment intervention after the study is completed if they request.
Control group
Active

Outcomes
Primary outcome [1] 240735 0
Functional mobility will be measured using Timed up and go
Timepoint [1] 240735 0
Baseline, Post intervention, Post washout, end of second intervention.
Primary outcome [2] 240738 0
Postural balance will be measured by mediolateral postural sway
Timepoint [2] 240738 0
Baseline, Post intervention, Post washout, end of second intervention.
Secondary outcome [1] 257391 0
Fall rate will be measured prospectively using a falls diary.
Timepoint [1] 257391 0
Baseline, Post intervention, Post washout, end of second intervention 12 months post intervention
Secondary outcome [2] 295120 0
Lung volumes will be measured using the clinical measure of Vital Capacity using a spirometer (Pony brand).
Timepoint [2] 295120 0
Baseline, at the end of 5 weeks and again at ten weeks

Eligibility
Key inclusion criteria
Independently mobile community dwelling older adults
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Musculoskeletal injury
Recent unstable medical conditions that would preclude exercise

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)
At enrollment each particpant will be allocated a number. The allocation of numbers to active or treatment group will be performed by a central administrator who will hold the allocation schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243599 0
University
Name [1] 243599 0
University of Tasmania
Country [1] 243599 0
Australia
Primary sponsor type
University
Name
Universtiy of Tasmania
Address
the school of Human Life Sciences
Locked Bag 1320
Launceston
Tasmania 7250
Country
Australia
Secondary sponsor category [1] 237049 0
None
Name [1] 237049 0
Address [1] 237049 0
Country [1] 237049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243727 0
Tasmanian Health and Medical Research Human Ethics Committee
Ethics committee address [1] 243727 0
Ethics committee country [1] 243727 0
Australia
Date submitted for ethics approval [1] 243727 0
26/03/2009
Approval date [1] 243727 0
06/08/2009
Ethics approval number [1] 243727 0
H0010572

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

Contacts
Principal investigator
Name 30145 0
Address 30145 0
Country 30145 0
Phone 30145 0
Fax 30145 0
Email 30145 0
Contact person for public queries
Name 13392 0
Marie-Louise Bird
Address 13392 0
Locked Bag 1320
Launceston
Tasmania, 7250
Country 13392 0
Australia
Phone 13392 0
+61 3 6324 3123
Fax 13392 0
+61 3 6324 3658
Email 13392 0
[email protected]
Contact person for scientific queries
Name 4320 0
Marie-Louise Bird
Address 4320 0
Locked Bag 1320
Launceston
Tasmania, 7250
Country 4320 0
Australia
Phone 4320 0
+61 3 6324 3123
Fax 4320 0
+61 3 6324 3658
Email 4320 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.