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Trial registered on ANZCTR


Registration number
ACTRN12609000666224
Ethics application status
Approved
Date submitted
3/08/2009
Date registered
5/08/2009
Date last updated
6/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Yoga for Stroke
Scientific title
A yoga and meditation program to improve physical function, mood and quality of life in individuals with chronic stroke hemiparesis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 243446 0
Condition category
Condition code
Alternative and Complementary Medicine 239745 239745 0 0
Other alternative and complementary medicine
Stroke 239764 239764 0 0
Ischaemic
Stroke 239765 239765 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten-week yoga based program involving weekly 90 minute group classes instructed by a yoga instructor and daily 30 minute home practice which is based on recorded audio instructions.
Intervention includes all of the following modalities:
1) Yoga based exercises involving low intensity, low-weight bearing restorative movements and gentle stretching. Moderate rest periods between rounds and exercises. Practiced for 30-35 minutes in weekly group classes and 5-8 minutes in daily home practice.
2) Gentle breathing exercises involving breath awareness, diaphragmatic breathing, thoracic breathing, and increasing tidal volume. No breath retentions are performed. Practiced for 10 minutes in weekly group classes and 5 minutes in daily home practice.
3) Guided meditation while supine or sitting in chair. Meditation involves body and breath awareness while the body is kept still. Practiced for 20-30 minutes in weekly group classes and 20 minutes in daily home practice.
Intervention code [1] 237064 0
Behaviour
Intervention code [2] 237078 0
Rehabilitation
Comparator / control treatment
Participants are randomised to participate in either the ten-week yoga based intervention program or no treatment (wait listed) control group. The control group will be offered the intervention approximately 3 months after the 10 week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 240498 0
Assessment of fine motor coordination by the 9 hole peg test
Timepoint [1] 240498 0
1. Pre-intervention. Prior to 10-week period (yoga intervention program or no treatment).
2. Post-intervention. Completion of the 10-week period.
Primary outcome [2] 240499 0
Assessment of functional capacity will be assessed with the 2 minute walk test.
Timepoint [2] 240499 0
1. Pre-intervention. Prior to 10-week period (yoga intervention program or no treatment).
2. Post-intervention. Completion of the 10-week period.
Primary outcome [3] 240500 0
Static and dynamic postural balance will be assessed with the Berg Balance Scale.
Timepoint [3] 240500 0
1. Pre-intervention. Prior to 10-week period (yoga intervention program or no treatment).
2. Post-intervention. Completion of the 10-week period.
Primary outcome [4] 240501 0
Everyday motor function will be assessed with the Motor Assessment Scale.
Timepoint [4] 240501 0
1. Pre-intervention. Prior to 10-week period (yoga intervention program or no treatment).
2. Post-intervention. Completion of the 10-week period.
Secondary outcome [1] 257049 0
State-Trait Anxiety Inventory for Adults
Timepoint [1] 257049 0
1. Pre-intervention. Prior to 10-week period (yoga intervention program or no treatment).
2. Mid-intervention. Week 5 of the 10-week period.
3. Post-intervention. Completion of the 10-week period.
Secondary outcome [2] 257050 0
Geriatric depression scale
Timepoint [2] 257050 0
1. Pre-intervention. Prior to 10-week period (yoga intervention program or no treatment).
2. Mid-intervention. Week 5 of the 10-week period.
3. Post-intervention. Completion of the 10-week period.
Secondary outcome [3] 257051 0
Stroke Impact Scale
Timepoint [3] 257051 0
1. Pre-intervention. Prior to 10-week period (yoga intervention program or no treatment).
2. Mid-intervention. Week 5 of the 10-week period.
3. Post-intervention. Completion of the 10-week period.

Eligibility
Key inclusion criteria
minimum of 6 months elapsed time since stroke resulting in weakness on one side of the body (i.e., hemiparesis)
Minimum age
18 Years
Maximum age
95 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to ambulate independently or with supervision, with or without an assistive device.
2. Incomplete post-stroke rehabilitation.
3. Presence of a medical condition that would be contraindicated for participation in low intensity exercise activity.
4. Receptive aphasia that interferes with the ability to follow 2-step commands.
5. Currently participating in a regular yoga practice, structured exercise or physical activity program.

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)
Concealed allocation:
allocation by person independent to study in opaque concealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
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
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1995 0
5001
Recruitment postcode(s) [2] 1996 0
5000

Funding & Sponsors
Funding source category [1] 237439 0
Charities/Societies/Foundations
Name [1] 237439 0
National Stroke Foundation
Address [1] 237439 0
Level 7, 461 Bourke Street
Melbourne VIC 3000
Country [1] 237439 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country
Australia
Secondary sponsor category [1] 236928 0
Other Collaborative groups
Name [1] 236928 0
Satyananda Yoga Academy
Address [1] 236928 0
300 Mangrove Creek Road
Mangrove Creek NSW 2250
Country [1] 236928 0
Australia
Other collaborator category [1] 804 0
Individual
Name [1] 804 0
Susan Hillier
Address [1] 804 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country [1] 804 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239566 0
UniSA Human Research Ethics Committee
Ethics committee address [1] 239566 0
Ms Vicki Allen
Ethics and Compliance Officer
Research and Innovation Services
University of South Australia
Mawson Lakes Campus
Mawson Lakes Boulevard
Mawson Lakes SA 5095
Ethics committee country [1] 239566 0
Australia
Date submitted for ethics approval [1] 239566 0
12/02/2009
Approval date [1] 239566 0
15/04/2009
Ethics approval number [1] 239566 0
P069/09

Summary
Brief summary
There are two previous studies (Lynton, Kligler and Shiflett, 2007; Bastille and Gill-Body, 2004), which suggest yoga-based activity programs may be of benefit for stroke survivors but these studies have had quite small sample sizes and have not involved randomized control procedures, which prevent any firm conclusions. A sub study of the North East Melbourne Stroke Incidence Study (NEMESIS) has indicated that interventions which target physical impairment and mood have the potential to improve health-related quality of life in stroke survivors (Sturm et al, 2008). A yoga-based intervention may be able to provide benefits in terms of functional recovery and mood improvement due to its unique combination of exercise-like movements and meditation practices. Participation in yoga programs may be a cost effective, low side effect risk, option for addressing both physical and emotional disabilities in stroke survivors.
Trial website
http://www.unisa.edu.au/news/2009/090609A.asp
Trial related presentations / publications
Immink, M.A., Hillier, S.L. (2011). Yoga for chronic post-stroke hemiparesis: a pilot randomised controlled trial. International Journal of Stroke, 6(Suppl. 1), 17.

Garrett, R., Immink, M.A., Hillier, S.L. (2011). Becoming connected: The lived experience of yoga participation after stroke. Disability and Rehabilitation, 33(25-26), 2404-2415.

Immink, M.A., Hillier, S., Petkov J. (2014). A randomized controlled trial of yoga for chronic post-stroke hemiparesis: Motor function, mental health and quality of life outcomes. Topics in Stroke Rehabilitation, 21(3), 256-271.
Public notes

Contacts
Principal investigator
Name 30004 0
Address 30004 0
Country 30004 0
Phone 30004 0
Fax 30004 0
Email 30004 0
Contact person for public queries
Name 13251 0
Maarten Immink
Address 13251 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 13251 0
Australia
Phone 13251 0
+61 8 8302 2675
Fax 13251 0
Email 13251 0
maarten.immink@unisa.edu.au
Contact person for scientific queries
Name 4179 0
Maarten Immink
Address 4179 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide SA 5001
Country 4179 0
Australia
Phone 4179 0
+61 8 8302 2675
Fax 4179 0
Email 4179 0
maarten.immink@unisa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary