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Effects of Spinal Cord Injury Exercise Guidelines

Primary Purpose

Chronic Pain, Spinal Cord Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Control
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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.

Sites / Locations

  • University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise Condition

Wait-list Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Presence of Neuropathic Pain
Outcome Measure: Neuropathic Pain Diagnostic Questionnaire (DN-4) (total score range 0-10 with scores ≥ 4 indicating neuropathic pain).
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).
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.
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.
Subjective Well-being: Perceived Stress
Outcome Measure - Perceived Stress Scale. Lower scores indicated lower perceived stress (0-40 total score range)
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) .
Subjective Well-being: Life Satisfaction
Outcome Measure - Diener's Satisfaction with Life Scale. Scale range 5-35 with higher scores indicating greater life satisfaction.
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).
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
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.
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.
Inflammation Fidelity Checks
Check/control for acute infection that may influence inflammatory markers in the sample, a complete blood count will be performed.
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)
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)
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)
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)

Full Information

First Posted
August 16, 2019
Last Updated
June 1, 2021
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04160858
Brief Title
Effects of Spinal Cord Injury Exercise Guidelines
Official Title
Effects of the Spinal Cord Injury Exercise Guidelines on Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 16, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Wait-list control
Primary Outcome Measure Information:
Title
Change from Baseline, between and within group comparison, in Bodily Pain
Description
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).
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
International Spinal Cord Injury Pain Basic Data Set v2.0
Description
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).
Time Frame
Baseline, 3 months, 6 months
Title
Presence of Neuropathic Pain
Description
Outcome Measure: Neuropathic Pain Diagnostic Questionnaire (DN-4) (total score range 0-10 with scores ≥ 4 indicating neuropathic pain).
Time Frame
Baseline, 3 months, 6 months
Title
Inhibitory Control of Pain assessed by Conditioned Pain Modulation
Description
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).
Time Frame
Baseline, 3 months, 6 months
Title
Fasting plasma concentrations of cytokines IL-6
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Fasting plasma concentrations of cytokines TNF-α
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Subjective Well-being: Perceived Stress
Description
Outcome Measure - Perceived Stress Scale. Lower scores indicated lower perceived stress (0-40 total score range)
Time Frame
Baseline, 3 months, 6 months
Title
Subjective Well-being: Quality of Life
Description
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) .
Time Frame
Baseline, 3 months, 6 months
Title
Subjective Well-being: Life Satisfaction
Description
Outcome Measure - Diener's Satisfaction with Life Scale. Scale range 5-35 with higher scores indicating greater life satisfaction.
Time Frame
Baseline, 3 months, 6 months
Title
Subjective Well-being: Experiential Aspects of Participation
Description
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).
Time Frame
Baseline, 3 months, 6 months
Title
Economic Evaluation: Health Care Costs
Description
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
Time Frame
Baseline, 3 months, 6 months
Title
Health-related Quality of Life
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Capability Wellbeing
Description
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.
Time Frame
Baseline, 3 months, 6 months
Title
Inflammation Fidelity Checks
Description
Check/control for acute infection that may influence inflammatory markers in the sample, a complete blood count will be performed.
Time Frame
Baseline, 3 months, 6 months
Title
Intervention Fidelity Check: Peak power output over max aerobic arm crank test
Description
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)
Time Frame
Baseline, 3 months, 6 months
Title
Intervention Fidelity Check: 1 Repetition-Maximum strength test bench press
Description
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)
Time Frame
Baseline, 3 months, 6 months
Title
Intervention Fidelity Check : Peak oxygen uptake over max aerobic arm crank test
Description
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)
Time Frame
Baseline, 3 months, 6 months
Title
Intervention Fidelity Check : 1 Repetition-Maximum strength test seated row
Description
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)
Time Frame
Baseline, 3 months, 6 months
Other Pre-specified Outcome Measures:
Title
Fidelity of the fitness trainer and exercise counselor to their protocols
Description
To assess fidelity of the fitness trainer and exercise counselor to their protocols, similar to our previous studies, both will complete checklists during each session which will be reviewed by the NPA. The NPA will also make random checks of a subset of audio recordings of counseling sessions and real-time visits to the fitness training sessions. If deviations from the protocol occur, the NPA will provide corrective feedback.
Time Frame
Weekly during the intervention for the exercise group (24 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: (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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Martin Ginis, PhD
Phone
250.807.9768
Email
kathleen_martin.ginis@ubc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Femke Hoekstra, PhD
Phone
250 807-8876
Email
femke.hoekstra@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Martin Ginis, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1V 1V7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Martin Ginis, PhD
Phone
250-807-9768
Email
kathleen_martin.ginis@ubc.ca
First Name & Middle Initial & Last Name & Degree
Femke Hoekstra, PhD
Phone
250 807-8876
Email
femke.hoekstra@ubc.ca
First Name & Middle Initial & Last Name & Degree
Jan van der Scheer, PhD
First Name & Middle Initial & Last Name & Degree
Christopher West, PhD
First Name & Middle Initial & Last Name & Degree
Mohammad Ehsanul Karim, PhD
First Name & Middle Initial & Last Name & Degree
John (Kip) Kramer, PhD
First Name & Middle Initial & Last Name & Degree
Joel Singer, PhD
First Name & Middle Initial & Last Name & Degree
Jonathan Little, PhD
First Name & Middle Initial & Last Name & Degree
Kendra Todd, MSc
First Name & Middle Initial & Last Name & Degree
Jennifer Davis, PhD
First Name & Middle Initial & Last Name & Degree
Joan Úbeda-Colomer, PhD
First Name & Middle Initial & Last Name & Degree
Kathleen Martin Ginis, PhD
First Name & Middle Initial & Last Name & Degree
Femke Hoekstra, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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