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

Spinal Cord Injury Clinical Trial

— SCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656927
• Other study ID #: UHN-REB#15-9413-D
• Status: Completed
• Phase: N/A
• First received: January 12, 2016
• Last updated: July 27, 2016
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Behavioral:
• Yoga Condition

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptance and Action Questionnaire-II (AAQ-II)		Change from Baseline, 6 weeks, 12 weeks	No
Secondary	Hospital Anxiety and Depression Scale (HADS)		Change from Baseline, 6 weeks, 12 weeks	No
Secondary	General Self-Efficacy Scale (GSES)		Change from Baseline, 6 weeks, 12 weeks	No
Secondary	Post-Traumatic Growth Inventory-SF (PTGI-SF)		Change from Baseline, 6 weeks, 12 weeks	No
Secondary	Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)		Change from Baseline, 6 weeks, 12 weeks	No
Secondary	Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)		Change from Baseline, 6 weeks, 12 weeks	No
Secondary	Self-Compassion Scale-SF (SCS-SF)		Change from Baseline, 6 weeks, 12 weeks	No
Secondary	Brief Pain Inventory-SF (BPI-SF)		Change from Baseline, 6 weeks, 12 weeks	No
Secondary	Pain Catastrophizing Scale (PCS)		Change from Baseline, 6 weeks, 12 weeks	No