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Home-based Cycling for People With Lumbar Spinal Stenosis (FLEXCAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075539
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
The main objective of the study is to compare the efficacy on back-specific activity limitations at 4 months after-randomisation of home-based cycling using connected ergometric bicycles associated with usual care to usual care.

Condition or disease Intervention/treatment Phase
Symptomatic Lumbar Spinal Stenosis Other: Home-based cycling program Other: usual care Phase 3

Detailed Description:

Lumbar spinal stenosis is a prevalent and disabling condition in elderly people. Lumbar spinal stenosis results in back and leg pain when standing and walking (radicular claudication), while symptoms regress in sitting position. The inability to stand or walk significantly 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 treatments. Previous data suggested that laminectomy may be more effective on pain and function than conservative therapy. However, the benefit-risk balance of surgery should be carefully considered in this population with numerous co-morbidities, and evidence is inconsistent. Therefore, conservative therapy is usually the first line option. Data regarding exercise therapy are scarce. Flexion-based exercises are usually recommended. A pilot study suggested that flexion-based endurance training program, namely cycling, could be an effective and safe method to improve pain, function and health-related quality of life in elderly people with chronic lumbar pain. However, barriers to adhering to the program were detected and might have influenced clinical endpoints. Non-pharmacological interventions in spinal conditions are not 'one-size-fits-all' and measures to enhance adherence have to be applied.

The hypothesis is that home-based cycling using connected ergometric bicycles associated with usual care could be more effective than usual care in reducing back-specific activity limitations at 4 months in people with lumbar spinal stenosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: single-blind
Primary Purpose: Treatment
Official Title: Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Arm Intervention/treatment
Experimental: Home-based cycling program associated to usual care Other: Home-based cycling program

Usual care (i.e. standardized prescription of 6 sessions of outpatient physiotherapy), and

  • 1 supervised session of cycling aimed at explaining how to use the connected ergometric bicycle and at designing a personalized home-based cycling program
  • a 12-month home-based cycling program using connected ergometric bicycles which intensity and dose are self-determined
  • 3 phone or email contacts with a care provider to deliver positive feedbacks and encouragements

Outpatient physiotherapy Other: usual care
A prescription of 6 sessions of outpatient physiotherapy




Primary Outcome Measures :
  1. Change in back-specific activity limitations [ Time Frame: 4 months after-randomization ]
    Mean change from baseline in mean back-specific activity limitations in the previous month using the self-administered Oswestry Disability Index (ODI) total score (0 no limitations and 100 maximal limitations).


Secondary Outcome Measures :
  1. Change in maximal walking distance [ Time Frame: 4 months post-randomization ]
    Mean change from baseline in mean maximal walking distance (meters) using an adapted version of the self-paced walking-test

  2. Change in lumbar pain [ Time Frame: 4, 6 and 12 months post-randomization ]
    Mean change from baseline in mean low back pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain and 100 maximal pain)

  3. Change in radicular pain [ Time Frame: 4, 6 and 12 months post-randomization ]
    Mean change from baseline in mean radicular pain intensity in the previous 48 hrs on a self-administered 11-point pain numeric rating scale (0 no pain and 100 maximal pain)

  4. Change in the physical component of health-related quality of life [ Time Frame: 4, 6 and 12 months post-randomization ]
    Mean change from baseline in the mean physical component of health-related quality of life assessed by the physical component score of the self-administered 12-Item Short Form Survey (9.95 worst possible and 70.02 best possible)

  5. Change in lumbar spinal stenosis-specific activity limitations [ Time Frame: 4, 6 and 12 months post-randomization ]
    Mean change from baseline in mean LSS-specific activity limitations using the physical function subscore of the self-administered Zurich Claudication Questionnaire (1 no limitations and 4 maximal limitations)

  6. Change in back-specific activity limitations [ Time Frame: 6 and 12 months post-randomization ]
    Mean change from baseline in mean spine-specific activity limitations assessed by the total score of the self-administered Oswestry Disability Index (0 no limitations and 100 maximal limitations)

  7. Percentage of patients who undergo spinal surgery [ Time Frame: From baseline to 12 months post-randomization ]
    Self-reported spinal surgery for lumbar spinal stenosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age ≥ 50 year-old
  • radicular claudication (i.e. walking-induced low back, buttock and/or leg pain, relieved in siting and/or lumbar flexion positions) diagnosed by a physician
  • MRI or CT-scan findings consistent with LSS reported on a written radiology report provided by a board-certified radiologist or a resident in radiology

Exclusion Criteria:

  • inability to speak and/or read French language
  • inability or refusal to perform ergometric bicycle at home
  • patients already having an ergometric bicycle at home
  • history of lumbar spine surgery in the previous 12 months
  • cognitive disorders
  • severe neurologic or vascular disorders involving the lower limbs
  • contraindication to a rehabilitation program assessed by medical examination
  • people under tutorship or curatorship
  • protected adults

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075539


Contacts
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Contact: Christelle Nguyen, MD, PhD +33 1 58 41 25 35 christelle.nguyen2@aphp.fr
Contact: François Rannou, MD, PhD +33 1 58 41 29 45 francois.rannou@aphp.fr

Locations
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France
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin Recruiting
Paris, Île-de-France, France, 75014
Contact: Christelle Nguyen, MD, PhD    +33 1 58 41 29 45    christelle.nguyen2@aphp.fr   
Contact: François Rannou, MD, PhD    +33 1 58 41 25 35    francois.rannou@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Christelle Nguyen, MD, PhD Université de Paris, Faculté de Médecine Paris Descartes
Study Director: François Rannou, MD, PhD Université de Paris, Faculté de Médecine Paris Descartes
Study Chair: Isabelle Boutron, MD, PhD Université de Paris, Faculté de Médecine Paris Descartes
Publications:
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04075539    
Other Study ID Numbers: P160147
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Lumbar spinal stenosis
Neurogenic claudication
Low back pain
Exercise therapy
Endurance training
Cycling
Randomized trial
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases