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Completed

NCT Number: NCT02656927

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Yoga Condition

Behavioral

Primary outcomes

  1. Acceptance and Action Questionnaire-II (AAQ-II)

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Acronym: SCI

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
Jul 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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