Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Other: Home-based cycling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Home-based cycling<br>A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences | Other: Home-based cycling<br>* A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to home-based cycling | Assessed by a qualitative approach using semi-structured interviews | 3 months | 
| Facilitators to home-based cycling | Assessed by a qualitative approach using semi-structured interviews | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barriers to home-based cycling | Assessed by a qualitative approach using semi-structured interviews | Baseline | 
| Facilitators to home-based cycling | Assessed by a qualitative approach using semi-structured interviews | Baseline | 
| Number of training sessions to assess adherence to home-based cycling | assessed by automatic monitoring on a USB stick connected to the bicycle | 3 months | 
| Covered distance to assess adherence to home-based cycling | assessed by automatic monitoring on a USB stick connected to the bicycle | 3 months | 
| Duration of training sessions to assess adherence to home-based cycling | Number of training sessions, distance, duration and power assessed by automatic monitoring on a USB stick connected to the bicycle | 3 months | 
| Developed power to assess adherence to home-based cycling | assessed by automatic monitoring on a USB stick connected to the bicycle | 3 months | 
| Burden of a home-based cycling | Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden) | 3 months | 
| Mean change from baseline in mean lumbar pain in the past 48 hrs | Assessed by an 11-point numeric rating scale (0=no pan, and 100=maximal pain) | 3 months | 
| Mean change from baseline in mean radicular pain in the past 48 hrs | Assessed by an 11-point numeric rating scale (0=no pain, and 100=maximal pain) | 3 months | 
| Mean change from baseline in mean disability in the past 48 hrs | Assessed by an 11-point numeric rating scale (0=no disability, and 100=maximal disability) | 3 months | 
| Mean change from baseline in mean spine-specific activity limitation | Assessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation) | 3 months | 
| Mean change from baseline in mean maximum walking distance | Assessed by an adapted version of the self-paced walking test | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar spinal stenosis, Cycling, Lumbar-flexion-based training