Home-based Cycling for People With Lumbar Spinal Stenosis

Symptomatic Lumbar Spinal Stenosis Clinical Trial

— FLEXCAL  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04075539
• Other study ID #: P160147
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2023
• Est. completion date: March 2026

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Christelle Nguyen, MD, PhD
• Phone: +33 1 58 41 25 35
• Email: christelle.nguyen2[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 302
• Est. completion date: March 2026
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Spinal Stenosis
• Symptomatic Lumbar Spinal Stenosis

Intervention

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
• usual care
A prescription of 6 sessions of outpatient physiotherapy

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Nguyen C, Boutron I, Roren A, Baron G, Pauwels C, Lefèvre-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of patients who undergo spinal surgery	Self-reported spinal surgery for lumbar spinal stenosis	From baseline to 12 months post-randomization