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

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

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

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: Home-based cycling

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.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barriers to home-based cycling	Assessed by a qualitative approach using semi-structured interviews	Baseline
Facilitators to home-based cycling	Assessed by a qualitative approach using semi-structured interviews	Baseline
Number of training sessions to assess adherence to home-based cycling	assessed by automatic monitoring on a USB stick connected to the bicycle	3 months
Covered distance to assess adherence to home-based cycling	assessed by automatic monitoring on a USB stick connected to the bicycle	3 months
Duration of training sessions to assess adherence to home-based cycling	Number of training sessions, distance, duration and power assessed by automatic monitoring on a USB stick connected to the bicycle	3 months
Developed power to assess adherence to home-based cycling	assessed by automatic monitoring on a USB stick connected to the bicycle	3 months
Burden of a home-based cycling	Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden)	3 months
Mean change from baseline in mean lumbar pain in the past 48 hrs	Assessed by an 11-point numeric rating scale (0=no pan, and 100=maximal pain)	3 months
Mean change from baseline in mean radicular pain in the past 48 hrs	Assessed by an 11-point numeric rating scale (0=no pain, and 100=maximal pain)	3 months
Mean change from baseline in mean disability in the past 48 hrs	Assessed by an 11-point numeric rating scale (0=no disability, and 100=maximal disability)	3 months
Mean change from baseline in mean spine-specific activity limitation	Assessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation)	3 months
Mean change from baseline in mean maximum walking distance	Assessed by an adapted version of the self-paced walking test	3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Université Paris Descartes
• Investigators: Principal Investigator: Christelle Nguyen, MD, PhD, A_HP

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2016
• Primary Completion (Actual): December 21, 2016
• Study Completion (Actual): December 21, 2016

Study Registration Dates

• First Submitted: October 12, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Cycling; Lumbar spinal stenosis; Lumbar-flexion-based training
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: NI16029H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No