Clinical trial NCT03325309: Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis
Official title: Barriers and Facilitators to a Home-based Cycling Program Tailored to Patients' Preferences in Lumbar Spinal Stenosis Using Connected Ergometric Bicycles: a 3-month Open Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar spinal stenosis
Cycling
Lumbar-flexion-based training
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Université Paris Descartes
First posted: 2017-10-30
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 50 year-old with symptoms related to degenerative lumbar spinal stenosis

Brief summary: The purpose of this study is to determine whether a home-based cycling program for patients with lumbar spinal stenosis is a feasible and acceptable

Detailed description: Lumbar spinal stenosis is a prevalent and disabling condition in elderly individuals. Lumbar spinal stenosis results in lumbar and/or radicular leg pain when standing and walking, while symptoms regress in lumbar flexion positions and at rest. The inability to stand or walk 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. Laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option to avoid or delay surgery. Data regarding exercise therapy are scarce. Lumbar-flexion-based exercises are usually recommended. A pilot study suggested that lumbar-flexion-based endurance training, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly patients with chronic low back pain but barriers to adhering to the program were detected. Investigators aim to assess barriers and facilitators to a 3-month home-based cycling program in lumbar spinal stenosis.

Eligibility criteria: Inclusion Criteria:

* Fulfilment of International Society for the Study of Lumbar Spine clinical diagnosis criteria for lumbar spinal stenosis with the presence of at least 6 out of the 7 following criteria: "pain in the buttocks or legs while walking"; "flex forward to relieve symptoms"; "feel relief when using a shopping cart or bicycle"; "motor or sensory disturbance while walking"; "normal and symmetric foot pulses"; "lower extremity weakness"; and "low back pain"
* Lumbar spinal stenosis qualitatively detected on MRI or CT-scan

Exclusion Criteria:

* Inability to speak or read French
* Impossibility or refusal to have an ergometric bicycle at home
* Ongoing lumbar-flexion-based endurance training
* History of spinal surgery
* Cognitive impairment
* Neurological or vascular disorder involving the lower limbs
* Contraindication to cycling

Primary outcomes:
measure: Barriers to home-based cycling
timeFrame: 3 months
measure: Facilitators to home-based cycling
timeFrame: 3 months
Secondary outcomes:
measure: Barriers to home-based cycling
timeFrame: Baseline
measure: Facilitators to home-based cycling
timeFrame: Baseline
measure: Number of training sessions to assess adherence to home-based cycling
timeFrame: 3 months
measure: Covered distance to assess adherence to home-based cycling
timeFrame: 3 months
measure: Duration of training sessions to assess adherence to home-based cycling
timeFrame: 3 months
measure: Developed power to assess adherence to home-based cycling
timeFrame: 3 months
measure: Burden of a home-based cycling
timeFrame: 3 months
measure: Mean change from baseline in mean lumbar pain in the past 48 hrs
timeFrame: 3 months
measure: Mean change from baseline in mean radicular pain in the past 48 hrs
timeFrame: 3 months
measure: Mean change from baseline in mean disability in the past 48 hrs
timeFrame: 3 months
measure: Mean change from baseline in mean spine-specific activity limitation
timeFrame: 3 months
measure: Mean change from baseline in mean maximum walking distance
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis
Study officials:
affiliation: A_HP
name: Christelle Nguyen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pauwels C, Roren A, Gautier A, Linieres J, Rannou F, Poiraudeau S, Nguyen C. Home-based cycling program tailored to older people with lumbar spinal stenosis: Barriers and facilitators. Ann Phys Rehabil Med. 2018 May;61(3):144-150. doi: 10.1016/j.rehab.2018.02.005. Epub 2018 Feb 27.