Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury (NCT06259227) | Clinical Trial Compass
TerminatedNot Applicable
Cardiorespiratory Fitness Training in Patients With Incomplete Spinal Cord Injury
Stopped: The study was discontinued due to a departmental reorganization, combined with higher-than-expected screening dropout and insufficient eligible participants.
Netherlands19 participantsStarted 2024-01-11
Plain-language summary
The goal of this exploratory randomized controlled trial is to assess the effect of a personalized training intervention during primary rehabilitation of 6 weeks on cardiorespiratory fitness in individuals with subacute (\<6 months) spinal cord injury during primary rehabilitation and during follow-up. Secondary outcomes include the effect on gait assessments, pulmonary function, neurological status, muscle force, cardiometabolic risk factors, quality of life, functional independence and self-efficacy.
Participants in the intervention group will receive 2-3 personalized cardiorespiratory fitness-focused training sessions per week, for a period of 6 weeks. Participants in the control group will receive usual care.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of incomplete spinal cord injury based on a stable cause (e.g. traumatic)
* Spinal cord injury classification C or D on the American Spinal Injury Association (ASIA) impairment scale
* During this study in the subacute phase (\< 6 months post injury)
* Hospitalized in the Sint Maartenskliniek for a primary, inpatient rehabilitation program
* Older than 18 years of age
* Able to understand and perform study related procedures
* Capable to sit at least 3 times a day for 2 hours (prerequisites to start the active rehabilitation program)
* The ability to use an arm ergometer
Exclusion Criteria:
* Unable to give informed consent
* Language barrier
* Participating in another interventional study targeting cardiorespiratory fitness
* Have contraindications to perform exercise during the rehabilitation program
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in cardiorespiratory fitness
Timeframe: Baseline (T0), 6 weeks after T0 (T1), end of inpatient rehab (T2)* (average 3 months after T0), end of outpatient rehab (T4) (average 3 months after T2) , 3 months after end of outpatient rehab (T6)