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Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis (FLEXCAL Pilot)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Lumbar Spinal Stenosis

Treatments

Other: Home-based cycling

Study type

Observational

Funder types

Other

Identifiers

NCT03325309
NI16029H

Details and patient eligibility

About

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

Full 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.

Enrollment

15 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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