Home-based Cycling for People With Lumbar Spinal Stenosis

NCT04075539 | Recruiting Phase 3

• 2 other identifiers: P1601472023-A00601-44
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Symptomatic Lumbar Spinal Stenosis

Keywords

Lumbar spinal stenosis; Neurogenic claudication; Low back pain; Exercise therapy; Endurance training; Cycling; Randomized trial

Outcome Measures

Primary Outcomes (1)

• Change in back-specific activity limitations

  Mean change from baseline in mean back-specific activity limitations in the previous month using the self-administered Oswestry Disability Index (ODI) total score (0 no limitations and 100 maximal limitations).

  4 months after-randomization

Secondary Outcomes (7)

• Change in maximal walking distance

  4 months post-randomization

• Change in lumbar pain

  4, 6 and 12 months post-randomization

• Change in radicular pain

  4, 6 and 12 months post-randomization

• Change in the physical component of health-related quality of life

  4, 6 and 12 months post-randomization

• Change in lumbar spinal stenosis-specific activity limitations

  4, 6 and 12 months post-randomization

Study Arms (2)

Home-based cycling program associated to usual care

EXPERIMENTAL

Other: Home-based cycling program

Outpatient physiotherapy

OTHER

Other: usual care

Interventions

Home-based cycling program OTHER

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

Home-based cycling program associated to usual care

usual care OTHER

A prescription of 6 sessions of outpatient physiotherapy

Outpatient physiotherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (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, 75014, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 31982599 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christelle Nguyen, MD, PhD

  Université de Paris, Faculté de Médecine Paris Descartes

  PRINCIPAL INVESTIGATOR

• François Rannou, MD, PhD

  Université de Paris, Faculté de Médecine Paris Descartes

  STUDY DIRECTOR

• Isabelle Boutron, MD, PhD

  Université de Paris, Faculté de Médecine Paris Descartes

  STUDY CHAIR

Central Study Contacts

Christelle Nguyen, MD, PhD

CONTACT

+33 1 58 41 25 35; christelle.nguyen2@aphp.fr

Laetitia PEAUDECERF, PhD

CONTACT

+33 1 58 41 12 13; laetitia.peaudecerf@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: single-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: August 30, 2019
• Study Start: February 10, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-09

Locations

FR (1)