Effects of Spinal Cord Injury Exercise Guidelines

NCT04160858 | Active Not Recruiting DMC

• 1 other identifier: SCI Ex Guidelines Pain: RCT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Chronic Pain; Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

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

  Outcome Measure - SF-36 Bodily Pain (SF-36 Pain) subscale to assess pain severity and interference. Lower scores indicated greater bodily pain (0-100 total score range).

  Baseline, 3 months, 6 months

Secondary Outcomes (17)

• International Spinal Cord Injury Pain Basic Data Set v2.0

  Baseline, 3 months, 6 months

• Presence of Neuropathic Pain

  Baseline, 3 months, 6 months

• Inhibitory Control of Pain assessed by Conditioned Pain Modulation

  Baseline, 3 months, 6 months

• Fasting plasma concentrations of cytokines IL-6

  Baseline, 3 months, 6 months

• Fasting plasma concentrations of cytokines TNF-α

  Baseline, 3 months, 6 months

Other Outcomes (1)

• Fidelity of the fitness trainer and exercise counselor to their protocols

  Weekly during the intervention for the exercise group (24 weeks)

Study Arms (2)

Exercise Condition

EXPERIMENTAL

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.

Other: Exercise

Wait-list Control

ACTIVE COMPARATOR

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.

Other: Control

Interventions

Exercise OTHER

Spinal Cord Injury Exercise Guidelines: Participants will begin at the Starting Level which is 20 mins of moderate to vigorous aerobic activity 2x/week \& 3 sets of 10 repeats of strength training 2x/week. They will progress to Advanced Level which is 30 mins of moderate to vigorous aerobic activity 3x/week and 3 sets of 10 repetitions of strength training 2x/week. The intervention duration is 6 months.

Exercise Condition

Control OTHER

Wait-list control

Wait-list Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) adults aged \>18 with an spinal cord injury (SCI), traumatic or non-traumatic cause;
• (ii) ASIA impairment scale classifications A-D, injury levels C3 or below;
• (iii) \>12 mos post-injury \[criteria i-iii capture the group to whom the SCI Exercise Guidelines apply);
• (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;
• (v) report pain secondary to SCI that is classified as neuropathic and/or musculoskeletal (MSK) using theInternational SCI Pain Basic Data Set (v2.0) pain descriptions. \[The trial physiatrist will train the research coordinators to use the Data Set and will make final decisions on unclear cases.\];
• (vi) report \<40 min/wk of structured, moderate intensity, aerobic exercise and \<2 bouts/week of strength training (i.e. less than the Starting Level guideline) on a modified version of the Leisure Time Physical Activity Questionnaire-SCI (\<15% of Canadians with SCI currently achieve the Starting Level so the trial can assess the effects of increasing exercise to recommended levels;
• (vii) no medical contra-indications to performing a maximal exercise test;
• (viii) have access to a phone.

You may not qualify if:

• (i) chronic pain with exclusively non-MSK or non-neuropathic origins (e.g. headache, abdominal pain-because the effects of exercise on these pain types are unknown);
• (ii) insufficient diaphragmatic control and arm functioning to do upper-body exercise;
• (iii) live beyond driving distance of the research site;
• (iv) insufficient English language proficiency to complete questionnaires and converse with the fitness trainer and counselor;
• (v) have been previously told s/he has a cognitive or memory impairment;
• (vi) pregnant (because safety of the guidelines are unknown);
• (vii) hospital in-patient at the time of enrolment.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Chronic Pain; Spinal Cord Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kathleen Martin Ginis, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Keeping outcome assessors and data analysts blinded to the allocation (i.e. participants and groups identifiable by number only). This ensures unbiased ascertainment and analysis of outcomes. When participants arrive at the lab for testing, they will be instructed not to reveal their allocated condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The trial design is a two-arm, single-blinded ( i.e. assessors and analysts blinded to allocation), RCT with a 6-month intervention period and 6-month follow-up (Exercise condition only). After baseline assessments, participants will be randomly allocated to 6 mos of exercise ("Exercise") or a wait-list ("Control") using a 1:1 ratio. The trial is designed to be comparable to usual care and maximize PRECIS scores, while providing insight on mechanisms that may explain intervention effects.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: November 13, 2019
• Study Start: January 16, 2020
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)