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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months, 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline, between and within group comparison, in Bodily Pain

Secondary study objectives

Capability Wellbeing

Economic Evaluation: Health Care Costs

Fasting plasma concentrations of cytokines IL-6

+14 more

Other study objectives

Fidelity of the fitness trainer and exercise counselor to their protocols

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met