Home-based Cycling for People With Lumbar Spinal Stenosis
NCT ID: NCT04075539
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
302 participants
INTERVENTIONAL
2025-02-10
2028-02-29
Brief Summary
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Detailed Description
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The 2 main treatment options for lumbar spinal stenosis are conservative or surgical treatments. Previous data suggested that laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be carefully considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option. Data regarding exercise therapy are scarce. Flexion-based exercises are usually recommended. A pilot study suggested that flexion-based endurance training program, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly people with chronic lumbar pain. However, barriers to adhering to the program were detected and might have influenced clinical endpoints. Non-pharmacological interventions in spinal conditions are not 'one-size-fits-all' and measures to enhance adherence have to be applied.
The hypothesis is that home-based cycling using connected ergometric bicycles associated with usual care could be more effective than usual care in reducing back-specific activity limitations at 4 months in people with lumbar spinal stenosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Home-based cycling program associated to usual care
Home-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
Outpatient physiotherapy
usual care
A prescription of 6 sessions of outpatient physiotherapy
Interventions
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Home-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
usual care
A prescription of 6 sessions of outpatient physiotherapy
Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
ALL
No
Sponsors
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URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Christelle Nguyen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Université de Paris, Faculté de Médecine Paris Descartes
François Rannou, MD, PhD
Role: STUDY_DIRECTOR
Université de Paris, Faculté de Médecine Paris Descartes
Isabelle Boutron, MD, PhD
Role: STUDY_CHAIR
Université de Paris, Faculté de Médecine Paris Descartes
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Nguyen C, Boutron I, Roren A, Baron G, Pauwels C, Lefevre-Colau MM, Poiraudeau S, Dupeyron A, Coudeyre E, Rannou F. Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial. Ann Phys Rehabil Med. 2021 Mar;64(2):101351. doi: 10.1016/j.rehab.2019.12.006. Epub 2020 Jan 23. No abstract available.
Other Identifiers
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P160147
Identifier Type: -
Identifier Source: org_study_id
2023-A00601-44
Identifier Type: OTHER
Identifier Source: secondary_id
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