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Completed

NCT Number: NCT03325309

Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis

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

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based cycling

Other

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

Primary outcomes

  1. Barriers to home-based cycling

    Time frame: 3 months

    Assessed by a qualitative approach using semi-structured interviews

  2. Facilitators to home-based cycling

    Time frame: 3 months

    Assessed by a qualitative approach using semi-structured interviews

Secondary outcomes

  1. Barriers to home-based cycling

    Time frame: Baseline

    Assessed by a qualitative approach using semi-structured interviews

  2. Facilitators to home-based cycling

    Time frame: Baseline

    Assessed by a qualitative approach using semi-structured interviews

  3. Number of training sessions to assess adherence to home-based cycling

    Time frame: 3 months

    assessed by automatic monitoring on a USB stick connected to the bicycle

  4. Covered distance to assess adherence to home-based cycling

    Time frame: 3 months

    assessed by automatic monitoring on a USB stick connected to the bicycle

  5. Duration of training sessions to assess adherence to home-based cycling

    Time frame: 3 months

    Number of training sessions, distance, duration and power assessed by automatic monitoring on a USB stick connected to the bicycle

  6. Developed power to assess adherence to home-based cycling

    Time frame: 3 months

    assessed by automatic monitoring on a USB stick connected to the bicycle

  7. Burden of a home-based cycling

    Time frame: 3 months

    Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden)

  8. Mean change from baseline in mean lumbar pain in the past 48 hrs

    Time frame: 3 months

    Assessed by an 11-point numeric rating scale (0=no pan, and 100=maximal pain)

  9. Mean change from baseline in mean radicular pain in the past 48 hrs

    Time frame: 3 months

    Assessed by an 11-point numeric rating scale (0=no pain, and 100=maximal pain)

  10. Mean change from baseline in mean disability in the past 48 hrs

    Time frame: 3 months

    Assessed by an 11-point numeric rating scale (0=no disability, and 100=maximal disability)

  11. Mean change from baseline in mean spine-specific activity limitation

    Time frame: 3 months

    Assessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation)

  12. Mean change from baseline in mean maximum walking distance

    Time frame: 3 months

    Assessed by an adapted version of the self-paced walking test

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Université Paris Descartes

Registry information

Official study 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

Acronym: FLEXCAL Pilot

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2017
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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