Home-based Cycling for People With Lumbar Spinal Stenosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based cycling program, usual care.
- Who it may be relevant to
- Registry conditions: Symptomatic Lumbar Spinal Stenosis. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial
Overview
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.
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.
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
Primary outcome measures
- Change in back-specific activity limitations [Time frame: 4 months after-randomization]
Secondary outcome measures (7)
- Change in maximal walking distance [Time frame: 4 months post-randomization]
- Change in lumbar pain [Time frame: 4, 6 and 12 months post-randomization]
- Change in radicular pain [Time frame: 4, 6 and 12 months post-randomization]
- Change in the physical component of health-related quality of life [Time frame: 4, 6 and 12 months post-randomization]
- Change in lumbar spinal stenosis-specific activity limitations [Time frame: 4, 6 and 12 months post-randomization]
- Change in back-specific activity limitations [Time frame: 6 and 12 months post-randomization]
- Percentage of patients who undergo spinal surgery [Time frame: From baseline to 12 months post-randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Ap — Paris
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. PMID 31982599
Identifiers
NCT: NCT04075539 · P160147 · 2023-A00601-44