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Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03325309
Acronym
FLEXCAL Pilot
Enrollment
15
Registered
2017-10-30
Start date
2016-08-29
Completion date
2016-12-21
Last updated
2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar spinal stenosis, Cycling, Lumbar-flexion-based training

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.

Interventions

OTHERHome-based cycling

A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences

Sponsors

Université Paris Descartes
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Facilitators to home-based cycling3 monthsAssessed by a qualitative approach using semi-structured interviews
Barriers to home-based cycling3 monthsAssessed by a qualitative approach using semi-structured interviews

Secondary

MeasureTime frameDescription
Barriers to home-based cyclingBaselineAssessed by a qualitative approach using semi-structured interviews
Facilitators to home-based cyclingBaselineAssessed by a qualitative approach using semi-structured interviews
Number of training sessions to assess adherence to home-based cycling3 monthsassessed by automatic monitoring on a USB stick connected to the bicycle
Covered distance to assess adherence to home-based cycling3 monthsassessed by automatic monitoring on a USB stick connected to the bicycle
Duration of training sessions to assess adherence to home-based cycling3 monthsNumber 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 cycling3 monthsassessed by automatic monitoring on a USB stick connected to the bicycle
Burden of a home-based cycling3 monthsAssessed 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 hrs3 monthsAssessed 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 hrs3 monthsAssessed 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 hrs3 monthsAssessed by an 11-point numeric rating scale (0=no disability, and 100=maximal disability)
Mean change from baseline in mean spine-specific activity limitation3 monthsAssessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation)
Mean change from baseline in mean maximum walking distance3 monthsAssessed by an adapted version of the self-paced walking test

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026