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

NCT ID: NCT02656927

Last Updated: 2016-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Yoga Condition

Group Type EXPERIMENTAL

Yoga Condition

Intervention Type BEHAVIORAL

Wait-list Control Condition

Group Type PLACEBO_COMPARATOR

Yoga Condition

Intervention Type BEHAVIORAL

Interventions

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Yoga Condition

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Sander Hitzig

Affiliate Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sander L. Hitzig, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, University of Toronto

Kathryn J. Curtis, MA

Role: STUDY_DIRECTOR

York University

Other Identifiers

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UHN-REB#15-9413-D

Identifier Type: -

Identifier Source: org_study_id

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