Home-based cycling program for lumbar spinal stenosis
Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial
This study is testing if a home-based cycling program can help older adults with back and leg pain from lumbar spinal stenosis feel better and improve their daily activities.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 302 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Île-de-France Region) |
| Trial ID | NCT04075539 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a home-based cycling program using connected ergometric bicycles in improving back-specific activity limitations for patients with symptomatic lumbar spinal stenosis. Participants will engage in this cycling program alongside usual care, with the primary outcome measured at four months post-randomization. The study addresses the need for effective conservative treatment options for elderly patients suffering from debilitating back and leg pain. By focusing on adherence to the exercise regimen, the study seeks to enhance the overall health-related quality of life for these individuals.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with diagnosed radicular claudication and MRI or CT-scan findings consistent with lumbar spinal stenosis.
Not a fit: Patients who have had lumbar spine surgery in the past year or those with severe neurological or vascular disorders affecting the lower limbs may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve pain management and functional abilities for patients with lumbar spinal stenosis.
How similar studies have performed: Previous studies have suggested that exercise therapy, particularly cycling, may be effective for similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age ≥ 50 year-old * radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a physician * MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in radiology Exclusion Criteria: * inability to speak and/or read French language * inability or refusal to perform ergometric bicycle at home * patients already having an ergometric bicycle at home * history of lumbar spine surgery in the previous 12 months * cognitive disorders * severe neurologic or vascular disorders involving the lower limbs * contraindication to a rehabilitation program assessed by medical examination * people under tutorship or curatorship * protected adults
Where this trial is running
Paris, Île-de-France Region
- Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin — Paris, Île-de-France Region, France (Recruiting)
Study contacts
- Principal investigator: Christelle Nguyen, MD, PhD — Université de Paris, Faculté de Médecine Paris Descartes
- Study coordinator: Christelle Nguyen, MD, PhD
- Email: christelle.nguyen2@aphp.fr
- Phone: +33 1 58 41 25 35
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.