Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Paris, Île-de-France Region, 75014, France
Location status: Recruiting
NCT Number: NCT04075539
The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Phase 3
Paris, Île-de-France Region, 75014, France
Location status: Recruiting
Lumbar spinal stenosis is a prevalent and disabling condition in elderly people. Lumbar spinal stenosis results in back and leg pain when standing and walking (radicular claudication), while symptoms regress in sitting position. The inability to stand or walk significantly 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 treatments. Previous data suggested that laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be carefully considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option. Data regarding exercise therapy are scarce. Flexion-based exercises are usually recommended. A pilot study suggested that flexion-based endurance training program, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly people with chronic lumbar pain. However, barriers to adhering to the program were detected and might have influenced clinical endpoints. Non-pharmacological interventions in spinal conditions are not 'one-size-fits-all' and measures to enhance adherence have to be applied.
The hypothesis is that home-based cycling using connected ergometric bicycles associated with usual care could be more effective than usual care in reducing back-specific activity limitations at 4 months in people with lumbar spinal stenosis.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Usual care (i.e. standardized prescription of 6 sessions of outpatient physiotherapy), and
A prescription of 6 sessions of outpatient physiotherapy
Time frame: 4 months after-randomization
Mean change from baseline in mean back-specific activity limitations in the previous month using the self-administered Oswestry Disability Index (ODI) total score (0 no limitations and 100 maximal limitations).
Time frame: 4 months post-randomization
Mean change from baseline in mean maximal walking distance (meters) using an adapted version of the self-paced walking-test
Time frame: 4, 6 and 12 months post-randomization
Mean change from baseline in mean low back pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain and 100 maximal pain)
Time frame: 4, 6 and 12 months post-randomization
Mean change from baseline in mean radicular pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain and 100 maximal pain)
Time frame: 4, 6 and 12 months post-randomization
Mean change from baseline in the mean physical component of health-related quality of life assessed by the physical component score of the self-administered 12-Item Short Form Survey (9.95 worst possible and 70.02 best possible)
Time frame: 4, 6 and 12 months post-randomization
Mean change from baseline in mean LSS-specific activity limitations using the physical function subscore of the self-administered Zurich Claudication Questionnaire (1 no limitations and 4 maximal limitations)
Time frame: 6 and 12 months post-randomization
Mean change from baseline in mean spine-specific activity limitations assessed by the total score of the self-administered Oswestry Disability Index (0 no limitations and 100 maximal limitations)
Time frame: From baseline to 12 months post-randomization
Self-reported spinal surgery for lumbar spinal stenosis
Interested in participating?
Request InfoAssistance Publique - Hôpitaux de Paris
Other
Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial
Acronym: FLEXCAL
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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