RecruitingPhase 3NCT04075539

Home-based Cycling for People With Lumbar Spinal Stenosis

Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

302 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether an at-home cycling programme (using a stationary ergometric bicycle) can reduce pain and improve walking ability in people with lumbar spinal stenosis (LSS). LSS is a narrowing of the spinal canal in the lower back that pinches nerves and causes pain in the back, buttocks, and legs — particularly when walking. Cycling in a bent-forward position often relieves the pain because it opens up the spinal canal. This trial gives participants a bicycle to use at home and monitors whether this leads to real improvements over time. Spinal stenosis is very common in older adults and significantly limits quality of life. While surgery is an option, many patients prefer non-surgical approaches. This study tests a practical, low-cost home-based option that could be widely accessible if it proves effective. You may be eligible if: - You are 50 years of age or older - A doctor has diagnosed you with lumbar spinal stenosis causing radicular claudication (leg pain when walking) - An MRI or CT scan confirms findings consistent with LSS - You can read and/or speak French You may NOT be eligible if: - You cannot operate a stationary bicycle at home - You already own a stationary bicycle - You have had lumbar spine surgery in the past 12 months - You have cognitive disorders or severe neurological/vascular problems in the legs - You are under legal guardianship or protection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHome-based cycling program

Usual care (i.e. standardized prescription of 6 sessions of outpatient physiotherapy), and * 1 supervised session of cycling aimed at explaining how to use the connected ergometric bicycle and at designing a personalized home-based cycling program * a 12-month home-based cycling program using connected ergometric bicycles which intensity and dose are self-determined * 3 phone or email contacts with a care provider to deliver positive feedbacks and encouragements

OTHERusual care

A prescription of 6 sessions of outpatient physiotherapy


Locations(1)

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

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NCT04075539