Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis

NCT03325309 | Completed

• 1 other identifier: NI16029H
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Lumbar Spinal Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Barriers to home-based cycling

  Assessed by a qualitative approach using semi-structured interviews

  3 months

• Facilitators to home-based cycling

  Assessed by a qualitative approach using semi-structured interviews

  3 months

Secondary Outcomes (12)

• Barriers to home-based cycling

  Baseline

• Facilitators to home-based cycling

  Baseline

• Number of training sessions to assess adherence to home-based cycling

  3 months

• Covered distance to assess adherence to home-based cycling

  3 months

• Duration of training sessions to assess adherence to home-based cycling

  3 months

Study Arms (1)

Home-based cycling

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

Other: Home-based cycling

Interventions

Home-based cycling OTHER

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

Home-based cycling

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients over 50 year-old with symptoms related to degenerative lumbar spinal stenosis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Université Paris Descartes: collaborator

Study Sites (1)

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

Paris, 75014, France

Location

Related Publications (1)

• 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.

  PMID: 29499383 RESULT

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Christelle Nguyen, MD, PhD

  A_HP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 30, 2017
• Study Start: August 29, 2016
• Primary Completion: December 21, 2016
• Study Completion: December 21, 2016
• Last Updated: March 8, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)