Exercise Guidelines for Spinal Cord Injury

Overseen By Femke Hoekstra, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Non-MSK pain, Insufficient arm function, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

Over 85,000 Canadians live with a spinal cord injury (SCI). The vast majority experience chronic pain from neuropathic or musculoskeletal origins, with many reporting the pain to be more physically, psychologically and socially debilitating than the injury itself. Currently, pharmaceuticals are the front line treatment recommendation for SCI pain, despite having many side-effects and giving minimal relief. Alternatively, studies conducted in controlled lab and clinical settings suggest that exercise may be a safe, effective behavioural strategy for reducing SCI-related chronic pain. Two ways in which exercise may alleviate pain are by reducing inflammation and increasing descending inhibitory control. To date, no study has tested the effects of exercise, performed in a home-/community-setting, on chronic pain in adults with SCI. Furthermore, information on the exercise dose required to alleviate chronic SCI pain is virtually non-existent, making it impossible for clinicians and fitness trainers to make evidence- informed recommendations regarding the types and amounts of exercise to perform in order to manage SCI pain. Recently (2018), an international team published two scientific SCI exercise guidelines: one to improve fitness and one to improve cardiometabolic health. These scientific guidelines have been translated into Canadian community SCI exercise guidelines and provide the exercise prescription for the proposed study. The investigators' overarching research question is: can home-/community-based exercise-prescribed according to these new SCI exercise guidelines and supported through a theory-based behavioural intervention- significantly reduce chronic pain in adults with SCI?

Research Team

Kathleen Martin Ginis, PhD

Principal Investigator

University of British Columbia

Eligibility Criteria

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.

Inclusion Criteria

You are physically able to do a very strenuous exercise test.

My pain from spinal cord injury is either nerve or muscle related.

You don't currently do enough exercise, as defined by specific guidelines, so the trial can see how increasing exercise to recommended levels affects you.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in home-/community-based exercise prescribed according to the SCI exercise guidelines for 6 months

24 weeks

Weekly check-ins with fitness trainer and exercise counselor

Follow-up

Participants are monitored for changes in chronic pain, inflammation, and well-being after the treatment phase

4 weeks

Treatment Details

Interventions

• Exercise

Trial Overview 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.

Participant Groups

Group I: Exercise Condition Experimental Treatment 1 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 Control Active Control 1 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.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+