Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-24 @ 11:58 PM
NCT ID:
NCT04160858
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04160858
Study Brief:
Protocol Section:
NCT04160858