Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

— FLEXCAL Pilot  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03325309
• Other study ID #: NI16029H
• Status: Completed
• Phase: N/A
• First received: October 12, 2017
• Last updated: March 6, 2018
• Start date: August 29, 2016
• Est. completion date: December 21, 2016

Study information

• Verified date: October 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 21, 2016
• Est. primary completion date: December 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Université Paris Descartes

Country where clinical trial is conducted

France, 

References & Publications (1)

Pauwels C, Roren A, Gautier A, Linières J, Rannou F, Poiraudeau S, Nguyen C. Barriers and facilitators to a home-based cycling program tailored to older patient preferences in lumbar spinal stenosis: a retrospective mixed-method study. Ann Phys Rehabil Me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barriers to home-based cycling	Assessed by a qualitative approach using semi-structured interviews	3 months
Primary	Facilitators to home-based cycling	Assessed by a qualitative approach using semi-structured interviews	3 months
Secondary	Barriers to home-based cycling	Assessed by a qualitative approach using semi-structured interviews	Baseline
Secondary	Facilitators to home-based cycling	Assessed by a qualitative approach using semi-structured interviews	Baseline
Secondary	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
Secondary	Covered distance to assess adherence to home-based cycling	assessed by automatic monitoring on a USB stick connected to the bicycle	3 months
Secondary	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
Secondary	Developed power to assess adherence to home-based cycling	assessed by automatic monitoring on a USB stick connected to the bicycle	3 months
Secondary	Burden of a home-based cycling	Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden)	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mean change from baseline in mean maximum walking distance	Assessed by an adapted version of the self-paced walking test	3 months