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

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yoga Condition
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal Cord Injury, Yoga, Psychological Flexibility, Mindfulness, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Yoga Condition

    Wait-list Control Condition

    Arm Description

    Outcomes

    Primary Outcome Measures

    Acceptance and Action Questionnaire-II (AAQ-II)

    Secondary Outcome Measures

    Hospital Anxiety and Depression Scale (HADS)
    General Self-Efficacy Scale (GSES)
    Post-Traumatic Growth Inventory-SF (PTGI-SF)
    Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)
    Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)
    Self-Compassion Scale-SF (SCS-SF)
    Brief Pain Inventory-SF (BPI-SF)
    Pain Catastrophizing Scale (PCS)

    Full Information

    First Posted
    January 12, 2016
    Last Updated
    July 27, 2016
    Sponsor
    University Health Network, Toronto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02656927
    Brief Title
    Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury (SCI)
    Acronym
    SCI
    Official Title
    Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University Health Network, Toronto

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injury
    Keywords
    Spinal Cord Injury, Yoga, Psychological Flexibility, Mindfulness, Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    22 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Yoga Condition
    Arm Type
    Experimental
    Arm Title
    Wait-list Control Condition
    Arm Type
    Placebo Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Yoga Condition
    Primary Outcome Measure Information:
    Title
    Acceptance and Action Questionnaire-II (AAQ-II)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks
    Secondary Outcome Measure Information:
    Title
    Hospital Anxiety and Depression Scale (HADS)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks
    Title
    General Self-Efficacy Scale (GSES)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks
    Title
    Post-Traumatic Growth Inventory-SF (PTGI-SF)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks
    Title
    Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks
    Title
    Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks
    Title
    Self-Compassion Scale-SF (SCS-SF)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks
    Title
    Brief Pain Inventory-SF (BPI-SF)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks
    Title
    Pain Catastrophizing Scale (PCS)
    Time Frame
    Change from Baseline, 6 weeks, 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sander L. Hitzig, PhD
    Organizational Affiliation
    University Health Network, University of Toronto
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Kathryn J. Curtis, MA
    Organizational Affiliation
    York University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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