Spinal Cord InjurySCINCT02656927
Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury (SCI)
A study testing Yoga Condition in people with Spinal Cord Injury, run by University Health Network, Toronto.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Yoga Condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Spinal Cord Injury
- Being tested
- Yoga Condition
- Keywords
- Spinal Cord Injury, Yoga, Psychological Flexibility, Mindfulness, Pain
- Medical subject headings
- Spinal Cord Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga ConditionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Yoga Condition | Experimental | Not described Receives: Behavioral: Yoga Condition |
| Wait-list Control Condition | Placebo comparator | Not described Receives: Behavioral: Yoga Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptance and Action Questionnaire-II (AAQ-II)
Measured: Change from Baseline, 6 weeks, 12 weeks
Secondary outcomes (8)
Hospital Anxiety and Depression Scale (HADS)
Measured: Change from Baseline, 6 weeks, 12 weeks
General Self-Efficacy Scale (GSES)
Measured: Change from Baseline, 6 weeks, 12 weeks
Post-Traumatic Growth Inventory-SF (PTGI-SF)
Measured: Change from Baseline, 6 weeks, 12 weeks
Connor-Davidson Resilience Scale-10 Item (CS-RISC-10)
Measured: Change from Baseline, 6 weeks, 12 weeks
Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)
Measured: Change from Baseline, 6 weeks, 12 weeks
Self-Compassion Scale-SF (SCS-SF)
Measured: Change from Baseline, 6 weeks, 12 weeks
Brief Pain Inventory-SF (BPI-SF)
Measured: Change from Baseline, 6 weeks, 12 weeks
Pain Catastrophizing Scale (PCS)
Measured: Change from Baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sander Hitzig, University Health Network, Toronto
- Investigators
- Sander L. Hitzig, PhD, Principal investigator, University Health Network, University of TorontoKathryn J. Curtis, MA, Study director, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656927
- Sponsor's protocol ID
- UHN-REB#15-9413-D
- Acronym
- SCI
- Status last verified
- Jul 2016
- First submitted
- 12 Jan 2016
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Specialized Yoga Program for Persons With Spinal Cord Injury: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02656927
- Acronym / sponsor ID
- SCI / UHN-REB#15-9413-D
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Yoga, Psychological Flexibility, Mindfulness, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Condition | Experimental | Behavioral: Yoga Condition |
| Wait-list Control Condition | Placebo comparator | Behavioral: Yoga Condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga Condition | Behavioural | Wait-list Control Condition, Yoga Condition |
Primary outcome
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: Change from Baseline, 6 weeks, 12 weeks
8 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change from Baseline, 6 weeks, 12 weeks
General Self-Efficacy Scale (GSES)
Time frame: Change from Baseline, 6 weeks, 12 weeks
Post-Traumatic Growth Inventory-SF (PTGI-SF)
Time frame: 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
Five Facet Mindfulness Questionnaire-SF (FFMQ-SF)
Time frame: Change from Baseline, 6 weeks, 12 weeks
Self-Compassion Scale-SF (SCS-SF)
Time frame: Change from Baseline, 6 weeks, 12 weeks
Brief Pain Inventory-SF (BPI-SF)
Time frame: Change from Baseline, 6 weeks, 12 weeks
Pain Catastrophizing Scale (PCS)
Time frame: Change from Baseline, 6 weeks, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sander L. Hitzig, PhD principal investigator
University Health Network, University of Toronto
Kathryn J. Curtis, MA study director
York University
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Condition in people with Spinal Cord Injury, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance and Action Questionnaire-II (AAQ-II) (time frame: Change from Baseline, 6 weeks, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.