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

NCT02656927 | Completed

• 1 other identifier: UHN-REB#15-9413-D
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Yoga; Psychological Flexibility; Mindfulness; Pain

Outcome Measures

Primary Outcomes (1)

• Acceptance and Action Questionnaire-II (AAQ-II)

  Change from Baseline, 6 weeks, 12 weeks

Secondary Outcomes (8)

• Hospital Anxiety and Depression Scale (HADS)

  Change from Baseline, 6 weeks, 12 weeks

• General Self-Efficacy Scale (GSES)

  Change from Baseline, 6 weeks, 12 weeks

• Post-Traumatic Growth Inventory-SF (PTGI-SF)

  Change from Baseline, 6 weeks, 12 weeks

• Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)

  Change from Baseline, 6 weeks, 12 weeks

• Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)

  Change from Baseline, 6 weeks, 12 weeks

Study Arms (2)

Yoga Condition

EXPERIMENTAL

Behavioral: Yoga Condition

Wait-list Control Condition

PLACEBO COMPARATOR

Behavioral: Yoga Condition

Interventions

Yoga Condition BEHAVIORAL

Wait-list Control Condition; Yoga Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Spinal Cord Injuries; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Sander L. Hitzig, PhD

  University Health Network, University of Toronto

  PRINCIPAL INVESTIGATOR

• Kathryn J. Curtis, MA

  York University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Scientist

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 15, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 28, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share