Chronic PainNCT04160858
Effects of Spinal Cord Injury Exercise Guidelines
A study testing Exercise in people with Chronic Pain and Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Spinal Cord Injuries
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jan 2020to 14 Feb 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Spinal Cord Injury Exercise Guidelines on Pain: A Randomized Controlled 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?
Read the detailed description
PROPOSED TRIAL. Using an integrated knowledge translation framework (iKT), the primary aim of this pragmatic Randomized Controlled Trial (RCT) is to examine the effects of 6 months of home-/community-based exercise, prescribed according to the SCI exercise guidelines, on chronic bodily pain experienced by adults with SCI. Secondary aims are to test for 1) differential effects on musculoskeletal and neuropathic pain; 2) changes in inflammation and inhibitory control as pathways by which exercise reduces pain; 3) effects of chronic pain reductions on subjective well-being; and 4) economic benefits of the intervention.
TRIAL MANAGEMENT. The experienced team of researchers has SCI-specific expertise in exercise psychology and physiology, pain and physiatry as well as health sciences expertise in immunology, biostatistics, health economics, and pragmatic RCT design and management. The team includes knowledge users representing local, provincial and national organizations, and a collaborator with lived experience of SCI.
SIGNIFICANCE. The investigators' novel idea is that home-/community-based exercise performed according to the SCI exercise guidelines can be an effective behavioural strategy for reducing chronic pain in adults with SCI. Critically, this will be the first SCI exercise RCT to use chronic bodily pain as the primary outcome and to assess potential pathways by which exercise may alleviate pain. Furthermore, this will be the first pragmatic RCT of exercise as a behavioural pain management strategy conducted among adults with SCI. Importantly, our community-engaged, iKT approach will ensure rapid translation and dissemination of findings to Canadian and international end-users including clinicians, fitness programmers, people living with SCI and the community organizations that support them.
- Conditions
- Chronic Pain, Spinal Cord Injuries
- Being tested
- Exercise, Control
- Medical subject headings
- Chronic Pain, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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.
ControlOther
Wait-list control
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months, 6 months
Secondary outcomes (17)
International Spinal Cord Injury Pain Basic Data Set v2.0
Measures overall interference of musculoskeletal and neuropathic pain, as well as the intensity of each specific pain location and type (up to three pain problems).
Measured: Baseline, 3 months, 6 months
Presence of Neuropathic Pain
Outcome Measure: Neuropathic Pain Diagnostic Questionnaire (DN-4) (total score range 0-10 with scores ≥ 4 indicating neuropathic pain).
Measured: Baseline, 3 months, 6 months
Inhibitory Control of Pain assessed by Conditioned Pain Modulation
This test measures the extent to which the application of a painful conditioning stimulus changes the perceived painfulness of a test stimulus. The test stimulus will be delivered by using a pressure algometer (contact area 1 cm2; Algomed Computerized Algometry; Medoc AMS), whereby the threshold for pressure induced pain will be measured on an upper extremity site that has sensory innervation, in 3 series of slowly increasing stimulus intensities (0.5 kg/s, corresponding to ca. 50 kPa/s). Participants will report the instant when pain is initially perceived, over and above the application of pressure. Pain threshold will be determined as the arithmetic mean of the 3 series (in kPA). Inhibitory control is calculated as the change in pain ratings for the test stimulus, from before to after application of the conditioning stimulus (bigger decreases in pain ratings indicate better inhibitory control/pain modulation).
Measured: Baseline, 3 months, 6 months
Fasting plasma concentrations of cytokines IL-6
Outcome Measure Blood Sampling - A fasting blood sample (>12 h) will be taken from the antecubital vein. IL-6 will be measured by high-sensitivity ELISA (R\&D Quantikine); fasting glucose (ADVIA1650, Siemens) and insulin (Roche Diagnostics, Mannheim, Germany) by automated clinical analyzers to calculate the corresponding homeostatic model assessment index; and triglycerides, total cholesterol and HDL cholesterol using an ADVIA 1650 chemistry system, after which LDL cholesterol is calculated.
Measured: Baseline, 3 months, 6 months
Fasting plasma concentrations of cytokines TNF-α
Outcome Measure Blood Sampling- A fasting blood sample (>12 h) will be taken from the antecubital vein. TNF-α will be measured by high-sensitivity ELISA (R\&D Quantikine); fasting glucose (ADVIA1650, Siemens) and insulin (Roche Diagnostics, Mannheim, Germany) by automated clinical analyzers to calculate the corresponding homeostatic model assessment index; and triglycerides, total cholesterol and HDL cholesterol using an ADVIA 1650 chemistry system, after which LDL cholesterol is calculated.
Measured: Baseline, 3 months, 6 months
Subjective Well-being: Perceived Stress
Outcome Measure - Perceived Stress Scale. Lower scores indicated lower perceived stress (0-40 total score range)
Measured: Baseline, 3 months, 6 months
Subjective Well-being: Quality of Life
Outcome Measure - SCI-QOL (Quality of Life) measurement system which measures of Positive Affect and Well-Being (scale range 10-50; higher scores greater positive affect and wellbeing), and Satisfaction with Social Roles and Activities (scale range 10-50; higher scores indicate greater satisfaction in social roles and activities) .
Measured: Baseline, 3 months, 6 months
Subjective Well-being: Life Satisfaction
Outcome Measure - Diener's Satisfaction with Life Scale. Scale range 5-35 with higher scores indicating greater life satisfaction.
Measured: Baseline, 3 months, 6 months
Subjective Well-being: Experiential Aspects of Participation
Outcome Measure: Measure of Experiential Aspects of Participation (MeEAP). This questionnaire measures Autonomy, Belongingness, Challenge, Engagement, Mastery and Meaning as experiential aspects of participation (score ranges 1-7 with higher scores indicating better participation experiences).
Measured: Baseline, 3 months, 6 months
Economic Evaluation: Health Care Costs
Outcome Measure - Health Care Utilization questionnaire (7 questions asking if and who they received health care care from, why and why not) Reference: Luc Noreau, Vanessa K. Noonan, John Cobb, Jean Leblond, Frédéric S. Dumont. Spinal Cord Injury Community Survey: A National, Comprehensive Study to Portray the Lives of Canadians with Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2014 Fall; 20(4): 249-264. Published online 2014 Oct 30. doi: 10.1310/sci2004-249
Measured: Baseline, 3 months, 6 months
Health-related Quality of Life
Outcome Measure - 5 level version of EuroQol-5D (EQ-5D). Overall scale range 5-25 with a lower score indicating a higher quality of life.
Measured: Baseline, 3 months, 6 months
Capability Wellbeing
Outcome Measure - an Index of Capability for Adults (ICECAP-A). Overall scale range 5-20 with a lower score indicating a lower index of capability in life.
Measured: Baseline, 3 months, 6 months
Inflammation Fidelity Checks
Check/control for acute infection that may influence inflammatory markers in the sample, a complete blood count will be performed.
Measured: Baseline, 3 months, 6 months
Intervention Fidelity Check: Peak power output over max aerobic arm crank test
Outcome Measure - progressive arm crank test to exhaustion using a Lode arm crank ergometer (Groningen, the Netherlands) and metabolic cart (TrueOne® 2400, ParvoMedics,Utah) [average max 30-s Watts produced, i.e. >0 W)
Measured: Baseline, 3 months, 6 months
Intervention Fidelity Check: 1 Repetition-Maximum strength test bench press
Outcome Measure - Multiple trials of 1-rep max bench press tests (to minimise learning effects as per the latest strength measurement guidelines) using HUR strength equipment (Kokkola, Finland) - [max Force produced, measured in kg, i.e. >0 W)
Measured: Baseline, 3 months, 6 months
Intervention Fidelity Check : Peak oxygen uptake over max aerobic arm crank test
Outcome Measure - progressive arm crank test to exhaustion using a Lode arm crank ergometer (Groningen, the Netherlands) and metabolic cart (TrueOne® 2400, ParvoMedics,Utah) - [average 30-s peak oxygen uptake measured, i.e. >0 L/min and >0 L/min/kg body mass)
Measured: Baseline, 3 months, 6 months
Intervention Fidelity Check : 1 Repetition-Maximum strength test seated row
Outcome Measure - and multiple trials of 1-rep max seated row tests (to minimise learning effects as per the latest strength measurement guidelines) using HUR strength equipment (Kokkola, Finland) - [max Force produced, measured in kg, i.e. >0 W)
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start16 Jan 2020
- Primary completion14 Feb 2025 (estimated)
- Study completion14 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Martin Ginis, University of British Columbia
- Investigators
- Kathleen Martin Ginis, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04160858
- Sponsor's protocol ID
- SCI Ex Guidelines Pain: RCT
- Status last verified
- Mar 2024
- First submitted
- 16 Aug 2019
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Spinal Cord Injury Exercise Guidelines on Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04160858
- Acronym / sponsor ID
- SCI Ex Guidelines Pain: RCT
- Conditions
- Chronic Pain, Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 16 Jan 2020 (actual)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 14 Feb 2025 (estimated)
- First posted
- 13 Nov 2019 (actual)
- 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.
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?
Detailed description
PROPOSED TRIAL. Using an integrated knowledge translation framework (iKT), the primary aim of this pragmatic Randomized Controlled Trial (RCT) is to examine the effects of 6 months of home-/community-based exercise, prescribed according to the SCI exercise guidelines, on chronic bodily pain experienced by adults with SCI. Secondary aims are to test for 1) differential effects on musculoskeletal and neuropathic pain; 2) changes in inflammation and inhibitory control as pathways by which exercise reduces pain; 3) effects of chronic pain reductions on subjective well-being; and 4) economic benefits of the intervention.
TRIAL MANAGEMENT. The experienced team of researchers has SCI-specific expertise in exercise psychology and physiology, pain and physiatry as well as health sciences expertise in immunology, biostatistics, health economics, and pragmatic RCT design and management. The team includes knowledge users representing local, provincial and national organizations, and a collaborator with lived experience of SCI.
SIGNIFICANCE. The investigators' novel idea is that home-/community-based exercise performed according to the SCI exercise guidelines can be an effective behavioural strategy for reducing chronic pain in adults with SCI. Critically, this will be the first SCI exercise RCT to use chronic bodily pain as the primary outcome and to assess potential pathways by which exercise may alleviate pain. Furthermore, this will be the first pragmatic RCT of exercise as a behavioural pain management strategy conducted among adults with SCI. Importantly, our community-engaged, iKT approach will ensure rapid translation and dissemination of findings to Canadian and international end-users including clinicians, fitness programmers, people living with SCI and the community organizations that support them.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exercise Condition | Experimental | Other: ExerciseThe 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. |
| Wait-list Control | Active comparator | Other: ControlControl 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- (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.];
Key exclusion criteria (7 listed)
- (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;
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 |
|---|---|---|
| ExerciseSpinal 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. | Other | Exercise Condition |
| ControlWait-list control | Other | Wait-list Control |
Primary outcome
Change from Baseline, between and within group comparison, in Bodily Pain
Time frame: Baseline, 3 months, 6 months
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).
17 secondary outcomes
International Spinal Cord Injury Pain Basic Data Set v2.0
Time frame: Baseline, 3 months, 6 months
Presence of Neuropathic Pain
Time frame: Baseline, 3 months, 6 months
Inhibitory Control of Pain assessed by Conditioned Pain Modulation
Time frame: Baseline, 3 months, 6 months
Fasting plasma concentrations of cytokines IL-6
Time frame: Baseline, 3 months, 6 months
Fasting plasma concentrations of cytokines TNF-α
Time frame: Baseline, 3 months, 6 months
Subjective Well-being: Perceived Stress
Time frame: Baseline, 3 months, 6 months
Subjective Well-being: Quality of Life
Time frame: Baseline, 3 months, 6 months
Subjective Well-being: Life Satisfaction
Time frame: Baseline, 3 months, 6 months
Subjective Well-being: Experiential Aspects of Participation
Time frame: Baseline, 3 months, 6 months
Economic Evaluation: Health Care Costs
Time frame: Baseline, 3 months, 6 months
Health-related Quality of Life
Time frame: Baseline, 3 months, 6 months
Capability Wellbeing
Time frame: Baseline, 3 months, 6 months
Inflammation Fidelity Checks
Time frame: Baseline, 3 months, 6 months
Intervention Fidelity Check: Peak power output over max aerobic arm crank test
Time frame: Baseline, 3 months, 6 months
Intervention Fidelity Check: 1 Repetition-Maximum strength test bench press
Time frame: Baseline, 3 months, 6 months
Intervention Fidelity Check : Peak oxygen uptake over max aerobic arm crank test
Time frame: Baseline, 3 months, 6 months
Intervention Fidelity Check : 1 Repetition-Maximum strength test seated row
Time frame: Baseline, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- 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.
Kathleen Martin Ginis, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Chronic Pain and Spinal Cord Injuries, run by University of British Columbia at 1 site in Canada.
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 8 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Change from Baseline, between and within group comparison, in Bodily Pain (time frame: Baseline, 3 months, 6 months). 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 29 Mar 2024.