ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Behavioral: Yoga Condition Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury: A Randomized Controlled Trial
Study Start Date : May 2016
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga Condition Behavioral: Yoga Condition
Placebo Comparator: Wait-list Control Condition Behavioral: Yoga Condition



Primary Outcome Measures :
  1. Acceptance and Action Questionnaire-II (AAQ-II) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]

Secondary Outcome Measures :
  1. Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  2. General Self-Efficacy Scale (GSES) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  3. Post-Traumatic Growth Inventory-SF (PTGI-SF) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  4. Connor-Davidson Resilience Scale-10 Item (CS-RISC-10) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  5. Five Facet Mindfulness Questionnaire-SF (FFMQ-SF) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  6. Self-Compassion Scale-SF (SCS-SF) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  7. Brief Pain Inventory-SF (BPI-SF) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]
  8. Pain Catastrophizing Scale (PCS) [ Time Frame: Change from Baseline, 6 weeks, 12 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656927


Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Sander L. Hitzig, PhD University Health Network, University of Toronto
Study Director: Kathryn J. Curtis, MA York University

Responsible Party: Sander Hitzig, Affiliate Scientist, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02656927     History of Changes
Other Study ID Numbers: UHN-REB#15-9413-D
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sander Hitzig, University Health Network, Toronto:
Spinal Cord Injury
Yoga
Psychological Flexibility
Mindfulness
Pain

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System