Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis

NCT ID: NCT03325309

Last Updated: 2018-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-29

Study Completion Date

2016-12-21

Brief Summary

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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

Detailed Description

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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.

Conditions

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Lumbar Spinal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Home-based cycling

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

Home-based cycling

Intervention Type OTHER

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

Interventions

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Home-based cycling

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université Paris Descartes

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christelle Nguyen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

A_HP

Locations

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Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 29499383 (View on PubMed)

Other Identifiers

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NI16029H

Identifier Type: -

Identifier Source: org_study_id

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