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| Name | Class |
|---|---|
| Université Paris Descartes | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based cycling | A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based cycling | Other | A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over 50 year-old with symptoms related to degenerative lumbar spinal stenosis
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| Name | Affiliation | Role |
|---|---|---|
| Christelle Nguyen, MD, PhD | A_HP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29499383 | Result | 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. |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |