Symptomatic Lumbar Spinal StenosisPhase 3FLEXCALNCT04075539
Home-based Cycling for People With Lumbar Spinal Stenosis
A Phase 3 study testing Home-based cycling program in people with Symptomatic Lumbar Spinal Stenosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Symptomatic Lumbar Spinal Stenosis
- What is being tested?
- Home-based cycling program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 10 Feb 2025to Feb 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- contraindication to a rehabilitation program assessed by medical examination
- people under tutorship or curatorship
- protected adults
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Assistance Publique - Hôpitaux de Paris, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
Paris, Île-de-France Region, 75014
Christelle Nguyen, MD, PhD, +33 1 58 41 29 45, christelle.nguyen2@aphp.fr
François Rannou, MD, PhD, +33 1 58 41 25 35, francois.rannou@aphp.fr
About this study
Official title: Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Symptomatic Lumbar Spinal Stenosis
- Being tested
- Home-based cycling program, usual care
- Keywords
- Lumbar spinal stenosis, Neurogenic claudication, Low back pain, Exercise therapy, Endurance training, Cycling, Randomized trial
- Medical subject headings
- Spinal Stenosis, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based cycling programOther
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
usual careOther
A prescription of 6 sessions of outpatient physiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Home-based cycling program associated to usual care | Experimental | Not described Receives: Other: Home-based cycling program |
| Outpatient physiotherapy | Other | Not described Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in back-specific activity limitations
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).
Measured: 4 months after-randomization
Secondary outcomes (7)
Change in maximal walking distance
Mean change from baseline in mean maximal walking distance (meters) using an adapted version of the self-paced walking-test
Measured: 4 months post-randomization
Change in lumbar pain
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)
Measured: 4, 6 and 12 months post-randomization
Change in radicular pain
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)
Measured: 4, 6 and 12 months post-randomization
Change in the physical component of health-related quality of life
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)
Measured: 4, 6 and 12 months post-randomization
Change in lumbar spinal stenosis-specific activity limitations
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)
Measured: 4, 6 and 12 months post-randomization
Change in back-specific activity limitations
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)
Measured: 6 and 12 months post-randomization
Percentage of patients who undergo spinal surgery
Self-reported spinal surgery for lumbar spinal stenosis
Measured: From baseline to 12 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start10 Feb 2025
- Primary completionJun 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christelle Nguyen, MD, PhD, Principal investigator, Université de Paris, Faculté de Médecine Paris DescartesFrançois Rannou, MD, PhD, Study director, Université de Paris, Faculté de Médecine Paris DescartesIsabelle Boutron, MD, PhD, Study chair, Université de Paris, Faculté de Médecine Paris Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075539
- Sponsor's protocol ID
- P160147
- Other IDs
- 2023-A00601-44
- Acronym
- FLEXCAL
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nguyen C, Boutron I, Roren A, Baron G, Pauwels C, Lefevre-Colau MM, Poiraudeau S, Dupeyron A, Coudeyre E, Rannou F. Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial. Ann Phys Rehabil Med. 2021 Mar;64(2):101351. doi: 10.1016/j.rehab.2019.12.006. Epub 2020 Jan 23. No abstract available.
PubMed 31982599
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Cycling Using Connected Ergometric Bicycles for People With Lumbar Spinal Stenosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04075539
- Acronym / sponsor ID
- FLEXCAL / P160147
- Conditions
- Symptomatic Lumbar Spinal Stenosis
- Keywords
- Lumbar spinal stenosis, Neurogenic claudication, Low back pain, Exercise therapy, Endurance training, Cycling, Randomized trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 30 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based cycling program associated to usual care | Experimental | Other: Home-based cycling program |
| Outpatient physiotherapy | Other | Other: usual care |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based cycling programUsual 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 | Other | Home-based cycling program associated to usual care |
| usual careA prescription of 6 sessions of outpatient physiotherapy | Other | Outpatient physiotherapy |
Primary outcome
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).
7 secondary outcomes
Change in maximal walking distance
Time frame: 4 months post-randomization
Change in lumbar pain
Time frame: 4, 6 and 12 months post-randomization
Change in radicular pain
Time frame: 4, 6 and 12 months post-randomization
Change in the physical component of health-related quality of life
Time frame: 4, 6 and 12 months post-randomization
Change in lumbar spinal stenosis-specific activity limitations
Time frame: 4, 6 and 12 months post-randomization
Change in back-specific activity limitations
Time frame: 6 and 12 months post-randomization
Percentage of patients who undergo spinal surgery
Time frame: From baseline to 12 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 31982599Nguyen C, Boutron I, Roren A, Baron G, Pauwels C, Lefevre-Colau MM, Poiraudeau S, Dupeyron A, Coudeyre E, Rannou F. Home-based cycling using connected ergometric bicycles for people with lumbar spinal stenosis (FLEXCAL): Protocol for a randomised trial. Ann Phys Rehabil Med. 2021 Mar;64(2):101351. doi: 10.1016/j.rehab.2019.12.006. Epub 2020 Jan 23. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christelle Nguyen, MD, PhD principal investigator
Université de Paris, Faculté de Médecine Paris Descartes
François Rannou, MD, PhD study director
Université de Paris, Faculté de Médecine Paris Descartes
Isabelle Boutron, MD, PhD study chair
Université de Paris, Faculté de Médecine Paris Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Home-based cycling program in people with Symptomatic Lumbar Spinal Stenosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christelle Nguyen, MD, PhD (+33 1 58 41 25 35, christelle.nguyen2@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in back-specific activity limitations (time frame: 4 months after-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075539, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.