Personalized fitness training for patients with incomplete spinal cord injury
Personalized Cardiorespiratory Fitness Training in Patients with Incomplete Spinal Cord Injury During Primary Rehabilitation
This study tests whether personalized fitness training can help people with incomplete spinal cord injuries improve their health and recovery during rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sint Maartenskliniek Academic / other |
| Locations | 1 site (Ubbergen) |
| Trial ID | NCT06259227 on ClinicalTrials.gov |
What this trial studies
This exploratory randomized controlled trial aims to evaluate the impact of a personalized cardiorespiratory fitness training intervention on individuals with subacute incomplete spinal cord injury during their primary rehabilitation. Participants will engage in 2-3 training sessions per week for six weeks, while a control group will receive standard care. The study will assess various outcomes, including cardiorespiratory fitness, gait assessments, pulmonary function, and quality of life, to determine the effectiveness of the intervention in improving overall health and rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old with a diagnosis of incomplete spinal cord injury who are in the subacute phase of recovery and are hospitalized for primary rehabilitation.
Not a fit: Patients who are unable to provide informed consent, have language barriers, or have contraindications to exercise will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance cardiorespiratory fitness and overall health outcomes for patients with incomplete spinal cord injuries.
How similar studies have performed: While there have been studies focusing on rehabilitation in spinal cord injury patients, this specific approach targeting incomplete spinal cord injuries with personalized fitness training is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ubbergen
- Sint Maartenskliniek — Ubbergen, Netherlands (Recruiting)
Study contacts
- Principal investigator: Ilse van Nes, Dr. — Sint Maartenskliniek
- Study coordinator: Maxime van Oort
- Email: m.vanoort@maartenskliniek.nl
- Phone: +31651943045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.