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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03325309
Other study ID # NI16029H
Secondary ID
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
Health authority
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

Study Design


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
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