Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury (SCI)

Not Applicable

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT02656927
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Study Start: 2016-05
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. have an SCI or a spinal related condition,
2. be 18 years of age or older,
3. be able to speak and read English,
4. commit to two weekly, one hour yoga classes for six weeks,
5. be referred from a clinician on the inter-disciplinary team,
6. have a sitting tolerance of one hour,
7. be able to participate in gentle physical activity in that time,
8. be aware of and understand his/her health contraindications (is able to practice safely),
9. 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

1. are not medically stable,
2. have pre-existing medical contraindications,
3. have cognitive limitations or language comprehension issues that would impact participation (determined by care team),
4. have had a regular yoga practice in the last six months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Acceptance and Action Questionnaire-II (AAQ-II)	Change from Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Name	Time	Method
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
General Self-Efficacy Scale (GSES)	Change from Baseline, 6 weeks, 12 weeks
Post-Traumatic Growth Inventory-SF (PTGI-SF)	Change from Baseline, 6 weeks, 12 weeks