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Clinical Trials/NCT02656927
NCT02656927
Completed
Not Applicable

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

University Health Network, Toronto0 sites22 target enrollmentMay 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Spinal Cord Injury
Sponsor
University Health Network, Toronto
Enrollment
22
Primary Endpoint
Acceptance and Action Questionnaire-II (AAQ-II)
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sander Hitzig

Affiliate Scientist

University Health Network, Toronto

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Acceptance and Action Questionnaire-II (AAQ-II)

Time Frame: Change from Baseline, 6 weeks, 12 weeks

Secondary Outcomes

  • Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)(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)
  • Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)(Change from Baseline, 6 weeks, 12 weeks)
  • Hospital Anxiety and Depression Scale (HADS)(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)

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