Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000519257
Ethics application status
Approved
Date submitted
24/06/2009
Date registered
30/06/2009
Date last updated
29/11/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Yoga and exercise for stroke.
Scientific title
A pilot study on yoga and meditation as an adjunct to fitness rehabilitation programs for stroke patients with chronic hemiparesis.
Secondary ID [1] 253206 0
123
Universal Trial Number (UTN)
Trial acronym
The YES Trial.
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 236963 0
Chronic hemiparesis 236964 0
Mood disorders 236965 0
Depressive disorders 236966 0
Condition category
Condition code
Stroke 237311 237311 0 0
Ischaemic
Mental Health 237312 237312 0 0
Depression
Alternative and Complementary Medicine 237313 237313 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Yoga and meditation as an adjunct to stroke fitness rehabilitation. The yoga and meditation with exercise intervention group will participate for 8 weeks in an stroke exercise rehabilitation program (once a week) together with a yoga and meditation program (once a week).

The 8-week yoga and meditation program will consist of:

Eight once-a-week group classes of fully modified postures, breathing exercises and meditation practices based on the Satyananda Yoga system of practices. These practices will be fully adaptable for the individuals with stroke and various types of hemiparesis (eg. Upper body versus lower body). Classes will be held on the premises of the Centre for Physical Activity in Ageing (CPAA) at room C3. This will be held on a separate day from the stroke exercise rehabilitation, allowing for rest between the classes.

Yoga and meditation group classes will be 90 minutes in duration: 5-10 minutes of education on yoga; 5 minutes of body awareness/settling in; 25 minutes of modified combination of seated, supine, supported standing asana (adapted exercises) and pranayama (gentle breathing) practices adapted for individual needs as necessary; 30 minutes of guided seated or supine meditation; 15 minutes of questions and sharing of experiences.

Yoga instruction will be delivered by an accredited and insured yoga and meditation teacher, who will be under a casual contract, employed by University of South Australia (UniSA) for both the intervention and wait-listed control groups. Weili Chan, the principal investigator will be providing supervision of all yoga classes but will have no involvement in actual yoga instruction.

Daily home practice based on written programs developed by Dr. Maarten Immink (University of South Australia, School of Health Sciences), who is an exercise physiologist and accredited yoga and meditation teacher. Yoga and meditation home practices will consists of 30 minutes of modified exercises, breathing practices and guided meditation based on printed and audio-recorded instructions.
Intervention code [1] 236738 0
Rehabilitation
Intervention code [2] 236826 0
Other interventions
Comparator / control treatment
The wait-listed control group will only receive usual stroke exercise rehabilitation. After the 8 week intervention period, the wait-listed control group will have a chance to participate in the Yoga and Meditation intervention together with stroke exercise rehabilitation as well.

The 8 week CPAA stroke exercise rehabilitation program, which both the experimental and control groups will experience will consist of:

Eight once-a-week supervised group classes with adopted weight-bearing exercises conducted in a gym environment. Classes are between 50 minutes to 1 hour in length. These classes consist of a variation of wind-resistance cycling machines and treadmill activities (for cardiovascular benefit), pin-loaded weight machines, free weights and tera-band equipment. Intensity of the program would be reassessed by the CPAA exercise physiologist before the start of the intervention and would vary from individual to individual. Classes, which are part of the ongoing physical activity program at the CPAA are supervised by an accredited exercise physiologists.
Control group
Active

Outcomes
Primary outcome [1] 238210 0
State Trait Anxiety Inventory.

The State Trait Anxiety inventory is a combination of state and trait scales that measure the transient and enduring levels of anxiety in individuals.
Timepoint [1] 238210 0
Weeks 0, 4, 8
Primary outcome [2] 238211 0
Geriatric Depression Scale.

The Geriatric Depression Scales will measure the level of depression the elderly persons and can be used for all older adults.
Timepoint [2] 238211 0
Weeks 0, 4, 8
Primary outcome [3] 238212 0
Stroke Impact Scale.

The Stroke Impact Scale will measure emotion and quality of life in the stroke patients.
Timepoint [3] 238212 0
Weeks 0, 4, 8
Secondary outcome [1] 244522 0
Motor Assessment Scale.

The Motor Assessment scale will measure functional capabilities, mobility and motor function levels in the stroke patients.
Timepoint [1] 244522 0
Weeks 0, 8
Secondary outcome [2] 244523 0
Nine Hole Peg Test.

The Nine Hole Peg Test will measure overall arm function and dexterity in upper limb.
Timepoint [2] 244523 0
Weeks 0, 8
Secondary outcome [3] 244524 0
Six Minute Walk Distance.

The Six Minute Walk Distance will measure the gait speed and lower limb mobility function and can be used in all populations.

The test will be conducted in the gymnasium hall and the parameters marked out in a square using cones to cover a fixed parameter. Stopwatches will be used to track timing and then the distance covered will be measured using a tape measure to the nearest meter where the participant has completed the distance walked in six minutes.
Timepoint [3] 244524 0
Weeks 0, 8
Secondary outcome [4] 244525 0
Berg Balance Scale.

The Berg Balance Scale will measure overall balance parameters in the participants and can be used in all populations.
Timepoint [4] 244525 0
Weeks 0, 8

Eligibility
Key inclusion criteria
Participants to have a minimum of 6 months elapsed time since stroke and able to ambulate either independently or with supervision with or without an assistive device. Inidividuals who have completed acute post-stroke rehabilitation at the Center for Physical Activity in Ageing (South Australia) are eligible to participate.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded if they are unable to follow 2-step commands or are participating in another study or program involving exercise programs for balance improvement. Lastly, individuals who are involved in any form of structured exercise program other than the Center for Physical Activity in Ageing's stroke fitness rehabilitation program including Yoga and Tai Chi will be excluded.

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)
Subjects will be recruited thru invitation in the current stroke fitness classes that are conducted in the Center for Physical Activity in Ageing (CPAA). Once the participants have contacted the main investigator, they will be assessed if they are eligible for the trial via simple phone interview. The participants will then be invited via email, phone or mail to take part in the pre-intervention testing by a physiotherapist, Dr. Susan Hillier (blinded to the study), where they will be explained the participant sheets and the consent forms. Upon completion of the pre-intervention testing, the participants will be allocated a unique non-sequential number before the allocation.

The allocation process will be concealed, by using sealed opaque envelopes and this is done by an independent administrative staff at the CPAA not connected in anyway to the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be done using a program developed by Saghaei (2004). They will be randomised to control and intervention groups. Unique numbers will be generated for each participant in a non-sequential manner so as to prevent easy detection by the blinded researchers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait listed control.
8 weeks intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237200 0
University
Name [1] 237200 0
University of South Australia
Country [1] 237200 0
Australia
Funding source category [2] 237201 0
Charities/Societies/Foundations
Name [2] 237201 0
National Stroke Foundation
Country [2] 237201 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Stroke Foundation
Address
Level 7, 461 Bourke Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 4694 0
University
Name [1] 4694 0
University of South Australia
Address [1] 4694 0
North Terrace, Adelaide
South Australia 5000
Country [1] 4694 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239295 0
Royal Adelaide Hospital Research Ethics Committee
Ethics committee address [1] 239295 0
Research Ethics Committee,
Level 3, HANSON INSTITUTE,
THE ROYAL ADELAIDE HOSPITAL
South Australia 5000
Ethics committee country [1] 239295 0
Australia
Date submitted for ethics approval [1] 239295 0
19/04/2009
Approval date [1] 239295 0
21/05/2009
Ethics approval number [1] 239295 0
090506
Ethics committee name [2] 239306 0
University of South Australia Human Research Ethics Committee
Ethics committee address [2] 239306 0
North Terrace, Adelaide
South Australia 5000
Australia
Ethics committee country [2] 239306 0
Australia
Date submitted for ethics approval [2] 239306 0
25/05/2009
Approval date [2] 239306 0
05/06/2009
Ethics approval number [2] 239306 0
P138/09

Summary
Brief summary
Individuals with chronic post-stroke hemiparesis commonly face physical disability and some form of emotional or mood imbalance. Persisting physical and psychosocial disabilities could further worsen the individual’s condition due to reduced physical activity, leading to increased risk of fall and increased risk for chronic conditions.

Yoga presents a novel means of addressing post-stroke disabilities since it has the potential to both enhance motor function and mood. An intervention program that includes meditation training may potentially lend to larger improvements in mood, which in turn, may further enhance motor function recovery of balance and gait. Thus, this research hopes to be able to provide evidence that participation in yoga and meditation program may be a cost-effective and low risk approach to addressing physical and emotional disabilities in stroke survivors.
Trial website
n/a
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 29725 0
Address 29725 0
Country 29725 0
Phone 29725 0
Fax 29725 0
Email 29725 0
Contact person for public queries
Name 12972 0
Weili Chan, Russell
Address 12972 0
University of South Australia
School of Health Science
Playford Building P7-36
GPO BOX 2471 Adelaide SA 5001
Country 12972 0
Australia
Phone 12972 0
+61 433 11 6835
Fax 12972 0
Email 12972 0
russellchanweili@gmail.com
Contact person for scientific queries
Name 3900 0
Dr. Maarten Immink
Address 3900 0
University of South Australia
School of Health Science
Playford Building P7-03
GPO BOX 2471 Adelaide SA 5001
Country 3900 0
Australia
Phone 3900 0
+61 8 830 22675
Fax 3900 0
+61 8 830 22578
Email 3900 0
Maarten.Immink@unisa.edu.au

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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