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

July 27, 2016 updated by: Sander Hitzig, University Health Network, Toronto

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change from Baseline, 6 weeks, 12 weeks
Change from Baseline, 6 weeks, 12 weeks
General Self-Efficacy Scale (GSES)
Time Frame: Change from Baseline, 6 weeks, 12 weeks
Change from Baseline, 6 weeks, 12 weeks
Post-Traumatic Growth Inventory-SF (PTGI-SF)
Time Frame: Change from Baseline, 6 weeks, 12 weeks
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
Change from Baseline, 6 weeks, 12 weeks
Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)
Time Frame: Change from Baseline, 6 weeks, 12 weeks
Change from Baseline, 6 weeks, 12 weeks
Self-Compassion Scale-SF (SCS-SF)
Time Frame: Change from Baseline, 6 weeks, 12 weeks
Change from Baseline, 6 weeks, 12 weeks
Brief Pain Inventory-SF (BPI-SF)
Time Frame: Change from Baseline, 6 weeks, 12 weeks
Change from Baseline, 6 weeks, 12 weeks
Pain Catastrophizing Scale (PCS)
Time Frame: Change from Baseline, 6 weeks, 12 weeks
Change from Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 27, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN-REB#15-9413-D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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