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Home-based Cycling for People With Lumbar Spinal Stenosis

NCT04075539 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 302

Last updated 2025-11-20

No results posted yet for this study

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

Interventions

OTHER

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

OTHER

usual care

A prescription of 6 sessions of outpatient physiotherapy

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Christelle Nguyen, MD, PhD · Université de Paris, Faculté de Médecine Paris Descartes

  • François Rannou, MD, PhD · Université de Paris, Faculté de Médecine Paris Descartes

  • Isabelle Boutron, MD, PhD · Université de Paris, Faculté de Médecine Paris Descartes

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2027-06-30
Completion
2028-02-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04075539 on ClinicalTrials.gov