Clinical trial NCT04075539: Home-based Cycling for People With Lumbar Spinal Stenosis
Official title: Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Symptomatic Lumbar Spinal Stenosis
Keywords: Lumbar spinal stenosis
Neurogenic claudication
Low back pain
Exercise therapy
Endurance training
Cycling
Randomized trial
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 302
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in back-specific activity limitations
timeFrame: 4 months after-randomization
Secondary outcomes:
measure: Change in maximal walking distance
timeFrame: 4 months post-randomization
measure: Change in lumbar pain
timeFrame: 4, 6 and 12 months post-randomization
measure: Change in radicular pain
timeFrame: 4, 6 and 12 months post-randomization
measure: Change in the physical component of health-related quality of life
timeFrame: 4, 6 and 12 months post-randomization
measure: Change in lumbar spinal stenosis-specific activity limitations
timeFrame: 4, 6 and 12 months post-randomization
measure: Change in back-specific activity limitations
timeFrame: 6 and 12 months post-randomization
measure: Percentage of patients who undergo spinal surgery
timeFrame: From baseline to 12 months post-randomization
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
state: Île-de-France
Study officials:
affiliation: Université de Paris, Faculté de Médecine Paris Descartes
name: Christelle Nguyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Paris, Faculté de Médecine Paris Descartes
name: François Rannou, MD, PhD
role: STUDY_DIRECTOR
affiliation: Université de Paris, Faculté de Médecine Paris Descartes
name: Isabelle Boutron, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.