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

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury: A Randomized Controlled Trial

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Behavioral: Yoga Condition


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Condition<br> | Behavioral: Yoga Condition<br> <br> |
| Placebo Comparator: Wait-list Control Condition<br> | Behavioral: Yoga Condition<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance and Action Questionnaire-II (AAQ-II) |  | Change from Baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) |  | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Yoga, Spinal Cord Injury, Psychological Flexibility, Mindfulness, Pain