NCT02656927CompletedNot Applicable
Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury: A Randomized Controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 22
- Primary Endpoint
- Acceptance and Action Questionnaire-II (AAQ-II)
Study Overview
Brief Summary
The purpose of this randomized controlled study is to evaluate psychological variables, mindfulness, and pain in the context of a specialized yoga program for individuals with SCI. Participants will be randomized to either a wait-list control condition or to a specialized yoga program condition.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •have an SCI or a spinal related condition,
- •be 18 years of age or older,
- •be able to speak and read English,
- •commit to two weekly, one hour yoga classes for six weeks,
- •be referred from a clinician on the inter-disciplinary team,
- •have a sitting tolerance of one hour,
- •be able to participate in gentle physical activity in that time,
- •be aware of and understand his/her health contraindications (is able to practice safely),
- •provide a note from their physician indicating that it is safe for them to participate in a physical activity intervention, such as yoga.
Exclusion Criteria
- •are not medically stable,
- •have pre-existing medical contraindications,
- •have cognitive limitations or language comprehension issues that would impact participation (determined by care team),
- •have had a regular yoga practice in the last six months.
Arms & Interventions
Yoga Condition
Experimental
Intervention: Yoga Condition (Behavioral)
Wait-list Control Condition
Placebo Comparator
Intervention: Yoga Condition (Behavioral)
Outcomes
Primary Outcomes
Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Change from Baseline, 6 weeks, 12 weeks
Secondary Outcomes
- General Self-Efficacy Scale (GSES)(Change from Baseline, 6 weeks, 12 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Change from Baseline, 6 weeks, 12 weeks)
- Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)(Change from Baseline, 6 weeks, 12 weeks)
- Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)(Change from Baseline, 6 weeks, 12 weeks)
- Self-Compassion Scale-SF (SCS-SF)(Change from Baseline, 6 weeks, 12 weeks)
- Brief Pain Inventory-SF (BPI-SF)(Change from Baseline, 6 weeks, 12 weeks)
- Pain Catastrophizing Scale (PCS)(Change from Baseline, 6 weeks, 12 weeks)
- Post-Traumatic Growth Inventory-SF (PTGI-SF)(Change from Baseline, 6 weeks, 12 weeks)
Investigators
Sander Hitzig
Affiliate Scientist
University Health Network, Toronto
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