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Exercise Guidelines for Spinal Cord Injury

N/A
Waitlist Available
Led By Kathleen Martin Ginis, PhD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
(iv) reporting chronic pain, defined as pain that persists or recurs for more than 3 mos on a question taken from the US Model SCI Systems measures: ["Using a 0 to 10 scale with 10 being pain so severe you could not stand it and 0 being no pain, what has been the usual level of pain over the past 3 months?"] and scoring at or above 1;
(i) adults aged >18 with an spinal cord injury (SCI), traumatic or non-traumatic cause;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months
Awards & highlights

Study Summary

This trial will test whether home-/community-based exercise, prescribed according to new SCI exercise guidelines and supported through a theory-based behavioural intervention, can significantly reduce chronic pain in adults with SCI.

Who is the study for?
Adults over 18 with spinal cord injury (SCI), experiencing chronic pain for more than 3 months, and doing less than the recommended levels of exercise can join. They must be able to perform a maximal exercise test and have access to a phone. Those with recent injuries (<12 months) or medical conditions that make exercising unsafe cannot participate.Check my eligibility
What is being tested?
The trial is testing if following new SCI exercise guidelines in a home/community setting can significantly reduce chronic pain in adults with SCI. Participants will either follow these exercise recommendations or be part of a control group, to see which method is more effective at managing pain.See study design
What are the potential side effects?
While not explicitly stated, potential side effects from increased physical activity may include muscle soreness, fatigue, and an initial increase in pain symptoms as the body adjusts to the new exercise regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been experiencing pain for more than 3 months.
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I am over 18 and have a spinal cord injury.
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My spinal cord injury is classified between A-D and is at level C3 or lower.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline, between and within group comparison, in Bodily Pain
Secondary outcome measures
Capability Wellbeing
Economic Evaluation: Health Care Costs
Fasting plasma concentrations of cytokines IL-6
+14 more
Other outcome measures
Fidelity of the fitness trainer and exercise counselor to their protocols

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Exercise ConditionExperimental Treatment1 Intervention
The intervention is a personalized exercise prescription based on the International Scientific Spinal Cord Injury (SCI) Exercise Guidelines. Participants begin at the Starting Level guideline: 20 min aerobic exercise, 2x/wk, at 70% of heart rate reserve (or a Borg Continuous Ratio 0-10 rating of 6), & 3 sets of 10 repetitions of strengthening exercises (each major functioning muscle group at 50-80% of 1-rep max), 2x/wk. Participants will gradually increase aerobic exercise to 30 min, 3x/wk (i.e. the Advanced Level guideline). Exercise implementation will be supported by a fitness trainer and an exercise counsellor with SCI-specific training and experience.
Group II: Wait-list ControlActive Control1 Intervention
Control participants will not get an exercise prescription. They will be asked to refrain from lifestyle changes for 6 mos. After the 6-month waitlist period, Controls will receive the same resources as Exercisers.

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Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,412 Previous Clinical Trials
2,466,535 Total Patients Enrolled
Kathleen Martin Ginis, PhDPrincipal InvestigatorUniversity of British Columbia
3 Previous Clinical Trials
76 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~7 spots leftby Feb 2025