Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Other: Home-based cycling
- Registration Number
- NCT03325309
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Home-based cycling Home-based cycling A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences
- Primary Outcome Measures
Name Time Method Barriers to home-based cycling 3 months Assessed by a qualitative approach using semi-structured interviews
Facilitators to home-based cycling 3 months Assessed by a qualitative approach using semi-structured interviews
- Secondary Outcome Measures
Name Time Method Barriers to home-based cycling Baseline Assessed by a qualitative approach using semi-structured interviews
Facilitators to home-based cycling Baseline Assessed by a qualitative approach using semi-structured interviews
Number of training sessions to assess adherence to home-based cycling 3 months assessed by automatic monitoring on a USB stick connected to the bicycle
Covered distance to assess adherence to home-based cycling 3 months assessed by automatic monitoring on a USB stick connected to the bicycle
Duration of training sessions to assess adherence to home-based cycling 3 months Number of training sessions, distance, duration and power assessed by automatic monitoring on a USB stick connected to the bicycle
Developed power to assess adherence to home-based cycling 3 months assessed by automatic monitoring on a USB stick connected to the bicycle
Burden of a home-based cycling 3 months Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden)
Mean change from baseline in mean lumbar pain in the past 48 hrs 3 months Assessed by an 11-point numeric rating scale (0=no pan, and 100=maximal pain)
Mean change from baseline in mean radicular pain in the past 48 hrs 3 months Assessed by an 11-point numeric rating scale (0=no pain, and 100=maximal pain)
Mean change from baseline in mean disability in the past 48 hrs 3 months Assessed by an 11-point numeric rating scale (0=no disability, and 100=maximal disability)
Mean change from baseline in mean spine-specific activity limitation 3 months Assessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation)
Mean change from baseline in mean maximum walking distance 3 months Assessed by an adapted version of the self-paced walking test
Trial Locations
- Locations (1)
Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis
🇫🇷Paris, France