None listed
Conditions
Brief summary
Stroke is the leading cause of disability from physical, social and mental health impacts (e.g. 1 in 3 survivors have depression after stroke) and affects over 420,000 Australians, with 50,000 new events each year. Community-based options for preventing comorbidity and supporting recovery after stroke are limited. We are proposing to test whether a mindfulness-based intervention (MBI), specifically designed for survivors of stroke that uses movement and meditation to focus on body awareness and breathing is acceptable and feasible. Prior studies of MBIs in older adults, cardiac and cancer populations provide evidence of reduced stress, fatigue, mood disorders such as anxiety and depression, lower blood pressure and improved quality of life. Our aim is to perform a feasibility trial among people within 3-12 months of a stroke who are living at home. Participants will either receive the SASS intervention (12 week MBI program includes weekly group class and home practice) or attention control intervention (12 week social group). This research project will provide important pilot data for work that will have the potential to impact on a large number of survivors of stroke living in the community who need support with managing the consequences of their stroke. If successful this pilot data will provide the rationale for future related work which has the potential to save lives and improve the quality of life of thousands of survivors of stroke.
Interventions
Treatment Arm: Weekly 60 minute group movement-based yoga and mindfulness classes for 12 weeks (~4-5 participants per class). The program will teach mindfulness meditation through breathing and a set of postures that are appropriate for a beginner. The classes will allow for progression, but participants are always able to adjust to the level that best suits them on the day.
Intervention will be delivered by trained and experienced yoga teachers (one lead and one assistant per class).
Adherence
Treatment Arm: Weekly 60 minute group movement-based yoga and mindfulness classes for 12 weeks (~4-5 participants per class). The program will teach mindfulness meditation through breathing and a set of postures that are appropriate for a beginner. The classes will allow for progression, but participants are always able to adjust to the level that best suits them on the day. Intervention will be delivered by trained and experienced yoga teachers (one lead and one assistant per class). Adherence will be monitored using attendance logs. 20 minutes home practice of mindfulness meditation daily (provided on CD/audio link). Adherence will be monitored using participant diary.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18 years or more • Confirmed diagnosis of stroke whereby the last stroke event is between 3 and 12 months • Participants living in the community (not nursing home or aged care residential facilities) within 30 kms of BrainPark (770 Blackburn Rd, Clayton VIC 3168, Australia) • Have access to email and/or SMS (to access home practice guide, and receive class reminders) • Self-identify as users of electronic technology such as CD player (to access home practice guide) • Have a baseline Modified Rankin Score of 0 (i.e. no disability) to 4 (i.e. may require some assistance but not constant care); • Able to give informed written consent and can understand two-step verbal commands; already enrolled in other clinical trial, as long as there will be no issues with contamination to either trial, and that there is assurance that responder burden is minimal
Exclusion criteria
• Participants will be excluded if: • Undertaking a mindfulness program (meditation, Tai Chi, yoga) or have done these regularly (e.g. monthly in frequency) in the 12 months prior to stroke • Cannot verbally communicate in English. Due to constraints of our budget, translation of yoga intervention delivery by experts into other languages will not be possible • Have significant language or communication impairments that will restrict the ability to participate • Poor prognosis (unlikely to survive to 12 weeks following randomisation) • Presence of contraindications to MRI (e.g. metallic or electronic implants not known to be safe) • Suffer from claustrophobia (i.e. inability to be in MRI scans where space is constraint)
Outcome results
None listed