Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001265864
Ethics application status
Approved
Date submitted
3/12/2012
Date registered
3/12/2012
Date last updated
26/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving balance and mobility with a yoga program for older people
Scientific title
Can a 12 week yoga-based exercise program improve balance and mobility in older community-dwelling people?: a randomised controlled trial.
Secondary ID [1] 281614 0
Nil
Universal Trial Number (UTN)
U1111-1137-5640
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Older people at risk of falling 287897 0
Condition category
Condition code
Injuries and Accidents 288275 288275 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 288278 288278 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weeks of twice-weekly group-based yoga focusing on standing postures that are likely to challenge balance such as one-legged standing and side lunges. Each class with last for 1 hour and will be supervised by a qualified yoga instructor experienced with running classes for older people. Participants will also be instructed to complete a set of the yoga poses at home twice weekly.
Intervention code [1] 286149 0
Prevention
Intervention code [2] 286150 0
Lifestyle
Comparator / control treatment
Information booklet about fall risk factors and prevention
Control group
Active

Outcomes
Primary outcome [1] 288452 0
The standing balance component of the Short Physical Performance Battery (SPPB) with the addition of one-legged stance time. The three standing balance positions of the SPPB include standing for 10 seconds each with feet side by side, feet in semi-tandem and in tandem positions. The sum of time able to stand in the four positions (with addition of one-legged stance), up to a maximum of 40 seconds is the primary outcome measure.
Timepoint [1] 288452 0
Measured at baseline and after completion of the 12 week intervention
Secondary outcome [1] 300187 0
Timed sit to stand test with five repetitions- time it takes, measured in seconds, for the participant to stand up and sit down fives times from a standard height chair with their arms folded across their chest
Timepoint [1] 300187 0
Measured at baseline and after completion of the 12 week intervention
Secondary outcome [2] 300188 0
Timed four metre walk at fast pace- time taken to complete the task measured in seconds
Timepoint [2] 300188 0
Measured at baseline and after completion of the 12 week intervention
Secondary outcome [3] 300189 0
One-legged stance with eyes closed (time able to stand up to a maximum of 10 seconds)
Timepoint [3] 300189 0
Measured at baseline and after completion of the 12 week intervention
Secondary outcome [4] 300190 0
Falls self-efficacy, as measured with the Short Falls Efficacy Scale-International questionnaire.
Timepoint [4] 300190 0
Measured at baseline and after completion of the 12 week intervention

Eligibility
Key inclusion criteria
People are eligible for inclusion if they are community-dwelling (not resident in a nursing home or hostel), aged 59 years or over, are cognitively intact (defined as a score of greater than or equal to 7 on the Short Portable Mental Status Questionnaire), are not currently taking part in yoga or Tai Chi classes and are willing and able to take part in 12 weeks of group-based yoga
Minimum age
59 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Insufficient English language skills to communicate over the telephone, a medical condition that precludes participation in a yoga program

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)
To ensure allocation concealment, randomisation to groups will be undertaken by an investigator not involved in recruitment using a computer generated random number schedule with randomly permuted blocks sizes. Randomisation to intervention or control groups will occur after completion of baseline questionnaires and assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was devised with a computer generated random number schedule with randomly permuted blocks sizes.
Masking / blinding
Blinded (masking 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
Completed
Date of first participant enrolment
Anticipated
15/12/2011
Actual
15/12/2011
Date of last participant enrolment
Anticipated
Actual
22/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
54
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 6076 0
2193
Recruitment postcode(s) [2] 6077 0
2037
Recruitment postcode(s) [3] 6078 0
2007
Recruitment postcode(s) [4] 6079 0
2049
Recruitment postcode(s) [5] 6080 0
2009
Recruitment postcode(s) [6] 6081 0
2206
Recruitment postcode(s) [7] 6082 0
2204
Recruitment postcode(s) [8] 6083 0
2046
Recruitment postcode(s) [9] 6084 0
2039
Recruitment postcode(s) [10] 6085 0
2037
Recruitment postcode(s) [11] 6086 0
2195
Recruitment postcode(s) [12] 6087 0
2194
Recruitment postcode(s) [13] 6088 0
2203
Recruitment postcode(s) [14] 6089 0
2040
Recruitment postcode(s) [15] 6090 0
2042

Funding & Sponsors
Funding source category [1] 286421 0
Charities/Societies/Foundations
Name [1] 286421 0
The Trust Company Philanthropy Fund
Country [1] 286421 0
Australia
Funding source category [2] 286422 0
Charities/Societies/Foundations
Name [2] 286422 0
The Australian Association of Gerontology
Country [2] 286422 0
Australia
Primary sponsor type
Individual
Name
Dr Anne Tiedemann
Address
The George Institute for Global Health
PO Box M201 Missenden Rd
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 285206 0
Individual
Name [1] 285206 0
A/Prof Catherine Sherrington
Address [1] 285206 0
The George Institute for Global Health
PO Box M201 Missenden Rd
Camperdown NSW 2050
Country [1] 285206 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288502 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 288502 0
Level 6
Jane Foss Russell Building G02
University of Sydney NSW 2006
Ethics committee country [1] 288502 0
Australia
Date submitted for ethics approval [1] 288502 0
Approval date [1] 288502 0
17/11/2011
Ethics approval number [1] 288502 0
14265

Summary
Brief summary
This study aims to investigate the benefits of a yoga-based exercise program aimed at preventing falls in older people by improving their balance and mobility. The trial will evaluate the effect of a 12-week yoga program on balance and mobility in 54 older people, randomly split between two groups. The intervention group will participate in a twice weekly group-based program of yoga focusing on balance- challenging standing postures. An experienced yoga instructor will deliver the classes. The control group will receive information about falls risk factors and prevention, but will not participate in the classes. We expect that the yoga group participants will show significant improvements in measures of balance and mobility compared to the control group after the 12 week intervention period.
Trial website
Trial related presentations / publications
TIEDEMANN A, O’Rourke S, Sesto R, Sherrington C. A 12 week Iyengar yoga program improved balance and mobility in older community-dwelling people: a pilot randomized controlled trial. Journal of Gerontology: Medical Sciences 2013; 68(9):1068-75 doi:10.1093/gerona/glt087.
Public notes

Contacts
Principal investigator
Name 35008 0
Dr Anne Tiedemann
Address 35008 0
The George Institute for Global Health, GPO Box 5389 Sydney NSW 2001 Australia
Country 35008 0
Australia
Phone 35008 0
+61296570393
Fax 35008 0
Email 35008 0
[email protected]
Contact person for public queries
Name 18255 0
Dr Dr Anne Tiedemann
Address 18255 0
The George Institute for Global Health
PO Box M201 Missenden Rd, Camperdown
NSW 2050
Country 18255 0
Australia
Phone 18255 0
+61 2 96570393
Fax 18255 0
Email 18255 0
[email protected]
Contact person for scientific queries
Name 9183 0
Dr Dr Anne Tiedemann
Address 9183 0
The George Institute for Global Health
PO Box M201 Missenden Rd, Camperdown
NSW 2050
Country 9183 0
Australia
Phone 9183 0
+61 2 96570393
Fax 9183 0
Email 9183 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

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