Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis
Paris, 75014, France
NCT Number: NCT03325309
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
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Notify Me50 year and older
All sexes
Observational
Paris, 75014, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences
Time frame: 3 months
Assessed by a qualitative approach using semi-structured interviews
Time frame: 3 months
Assessed by a qualitative approach using semi-structured interviews
Time frame: Baseline
Assessed by a qualitative approach using semi-structured interviews
Time frame: Baseline
Assessed by a qualitative approach using semi-structured interviews
Time frame: 3 months
assessed by automatic monitoring on a USB stick connected to the bicycle
Time frame: 3 months
assessed by automatic monitoring on a USB stick connected to the bicycle
Time frame: 3 months
Number of training sessions, distance, duration and power assessed by automatic monitoring on a USB stick connected to the bicycle
Time frame: 3 months
assessed by automatic monitoring on a USB stick connected to the bicycle
Time frame: 3 months
Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden)
Time frame: 3 months
Assessed by an 11-point numeric rating scale (0=no pan, and 100=maximal pain)
Time frame: 3 months
Assessed by an 11-point numeric rating scale (0=no pain, and 100=maximal pain)
Time frame: 3 months
Assessed by an 11-point numeric rating scale (0=no disability, and 100=maximal disability)
Time frame: 3 months
Assessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation)
Time frame: 3 months
Assessed by an adapted version of the self-paced walking test
Assistance Publique - Hôpitaux de Paris
Other
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
Acronym: FLEXCAL Pilot
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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