Home-based Cycling for People With Lumbar Spinal Stenosis (FLEXCAL)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Symptomatic Lumbar Spinal Stenosis
• Intervention / Treatment: Other: Home-based cycling program; Other: usual care

Detailed Description

Lumbar spinal stenosis is a prevalent and disabling condition in elderly people. Lumbar spinal stenosis results in back and leg pain when standing and walking (radicular claudication), while symptoms regress in sitting position. The inability to stand or walk significantly impairs functioning and health-related quality of life of elders, and has an important healthcare cost.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 302
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Christelle Nguyen, MD, PhD; Phone Number: +33 1 58 41 25 35; Email: christelle.nguyen2@aphp.fr

Study Locations

• France
  • Île-de-France
    • Paris, Île-de-France, France, 75014
      • Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
      • Contact: François Rannou, MD, PhD; Phone Number: +33 1 58 41 25 35; Email: francois.rannou@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based cycling program associated to usual care	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: Outpatient physiotherapy	Other: usual care; A prescription of 6 sessions of outpatient physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maximal walking distance	Mean change from baseline in mean maximal walking distance (meters) using an adapted version of the self-paced walking-test	4 months post-randomization
Change in lumbar pain	Mean change from baseline in mean low back pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain and 100 maximal pain)	4, 6 and 12 months post-randomization
Change in radicular pain	Mean change from baseline in mean radicular pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain and 100 maximal pain)	4, 6 and 12 months post-randomization
Change in the physical component of health-related quality of life	Mean change from baseline in the mean physical component of health-related quality of life assessed by the physical component score of the self-administered 12-Item Short Form Survey (9.95 worst possible and 70.02 best possible)	4, 6 and 12 months post-randomization
Change in lumbar spinal stenosis-specific activity limitations	Mean change from baseline in mean LSS-specific activity limitations using the physical function subscore of the self-administered Zurich Claudication Questionnaire (1 no limitations and 4 maximal limitations)	4, 6 and 12 months post-randomization
Change in back-specific activity limitations	Mean change from baseline in mean spine-specific activity limitations assessed by the total score of the self-administered Oswestry Disability Index (0 no limitations and 100 maximal limitations)	6 and 12 months post-randomization
Percentage of patients who undergo spinal surgery	Self-reported spinal surgery for lumbar spinal stenosis	From baseline to 12 months post-randomization

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Christelle Nguyen, MD, PhD, Université de Paris, Faculté de Médecine Paris Descartes; Study Director: François Rannou, MD, PhD, Université de Paris, Faculté de Médecine Paris Descartes; Study Chair: Isabelle Boutron, MD, PhD, Université de Paris, Faculté de Médecine Paris Descartes

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: August 29, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Cycling; Low back pain; Randomized trial; Exercise therapy; Lumbar spinal stenosis; Neurogenic claudication; Endurance training
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: P160147

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No