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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02656927
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : July 28, 2016
Sponsor:
Information provided by (Responsible Party):
Sander Hitzig, University Health Network, Toronto

Tracking Information
First Submitted Date  ICMJE January 12, 2016
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date July 28, 2016
Study Start Date  ICMJE May 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
Acceptance and Action Questionnaire-II (AAQ-II) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  • General Self-Efficacy Scale (GSES) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  • Post-Traumatic Growth Inventory-SF (PTGI-SF) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  • Connor-Davidson Resilience Scale-10 Item (CS-RISC-10) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  • Five Facet Mindfulness Questionnaire-SF (FFMQ-SF) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  • Self-Compassion Scale-SF (SCS-SF) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  • Brief Pain Inventory-SF (BPI-SF) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  • Pain Catastrophizing Scale (PCS) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury (SCI)
Official Title  ICMJE Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury: A Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Behavioral: Yoga Condition
Study Arms  ICMJE
  • Experimental: Yoga Condition
    Intervention: Behavioral: Yoga Condition
  • Placebo Comparator: Wait-list Control Condition
    Intervention: Behavioral: Yoga Condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2016)
22
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
24
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656927
Other Study ID Numbers  ICMJE UHN-REB#15-9413-D
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sander Hitzig, University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sander L. Hitzig, PhD University Health Network, University of Toronto
Study Director: Kathryn J. Curtis, MA York University
PRS Account University Health Network, Toronto
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP