Lumbar Spinal StenosisFLEXCAL PilotNCT03325309
Barriers and Facilitators to Cycling for Lumbar Spinal Stenosis
An observational study of Lumbar Spinal Stenosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Home-based cycling
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 29 Aug 2016to 21 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients over 50 year-old with symptoms related to degenerative lumbar spinal stenosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Cochin -Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis
Paris, 75014
About this study
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
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
Read the detailed 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.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Home-based cycling
- Keywords
- Lumbar spinal stenosis, Cycling, Lumbar-flexion-based training
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based cyclingOther
A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences
| Study group | Role | What they receive |
|---|---|---|
| Home-based cycling | A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences Receives: Other: Home-based cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers to home-based cycling
Assessed by a qualitative approach using semi-structured interviews
Measured: 3 months
Facilitators to home-based cycling
Assessed by a qualitative approach using semi-structured interviews
Measured: 3 months
Secondary outcomes (12)
Barriers to home-based cycling
Assessed by a qualitative approach using semi-structured interviews
Measured: Baseline
Facilitators to home-based cycling
Assessed by a qualitative approach using semi-structured interviews
Measured: Baseline
Number of training sessions to assess adherence to home-based cycling
assessed by automatic monitoring on a USB stick connected to the bicycle
Measured: 3 months
Covered distance to assess adherence to home-based cycling
assessed by automatic monitoring on a USB stick connected to the bicycle
Measured: 3 months
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
Measured: 3 months
Developed power to assess adherence to home-based cycling
assessed by automatic monitoring on a USB stick connected to the bicycle
Measured: 3 months
Burden of a home-based cycling
Assessed by the Exercise Therapy Burden Questionnaire (0=no burden, and 100=maximal burden)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 months
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)
Measured: 3 months
Mean change from baseline in mean spine-specific activity limitation
Assessed by the Oswestry Disability Index (0=no limitation, and 100=maximal limitation)
Measured: 3 months
Mean change from baseline in mean maximum walking distance
Assessed by an adapted version of the self-paced walking test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start29 Aug 2016
- Primary completion21 Dec 2016
- Study completion21 Dec 2016
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Université Paris Descartes
- Responsible party
- Sponsor
- Investigators
- Christelle Nguyen, MD, PhD, Principal investigator, A_HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03325309
- Sponsor's protocol ID
- NI16029H
- Acronym
- FLEXCAL Pilot
- Status last verified
- Oct 2017
- First submitted
- 12 Oct 2017
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pauwels C, Roren A, Gautier A, Linieres J, Rannou F, Poiraudeau S, Nguyen C. Home-based cycling program tailored to older people with lumbar spinal stenosis: Barriers and facilitators. Ann Phys Rehabil Med. 2018 May;61(3):144-150. doi: 10.1016/j.rehab.2018.02.005. Epub 2018 Feb 27.
PubMed 29499383
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03325309
- Acronym / sponsor ID
- FLEXCAL Pilot / NI16029H
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar spinal stenosis, Cycling, Lumbar-flexion-based training
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Université Paris Descartes
- Study start
- 29 Aug 2016 (actual)
- Primary completion
- 21 Dec 2016 (actual)
- Study completion
- 21 Dec 2016 (actual)
- First posted
- 30 Oct 2017 (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 purpose of this study is to determine whether a home-based cycling program for patients with lumbar spinal stenosis is a feasible and acceptable
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based cycling | – | Other: Home-based cyclingA single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 50 year-old with symptoms related to degenerative lumbar spinal stenosis
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 cyclingA single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences | Other | Home-based cycling |
Primary outcome
Barriers to home-based cycling
Time frame: 3 months
Assessed by a qualitative approach using semi-structured interviews
Facilitators to home-based cycling
Time frame: 3 months
Assessed by a qualitative approach using semi-structured interviews
12 secondary outcomes
Barriers to home-based cycling
Time frame: Baseline
Facilitators to home-based cycling
Time frame: Baseline
Number of training sessions to assess adherence to home-based cycling
Time frame: 3 months
Covered distance to assess adherence to home-based cycling
Time frame: 3 months
Duration of training sessions to assess adherence to home-based cycling
Time frame: 3 months
Developed power to assess adherence to home-based cycling
Time frame: 3 months
Burden of a home-based cycling
Time frame: 3 months
Mean change from baseline in mean lumbar pain in the past 48 hrs
Time frame: 3 months
Mean change from baseline in mean radicular pain in the past 48 hrs
Time frame: 3 months
Mean change from baseline in mean disability in the past 48 hrs
Time frame: 3 months
Mean change from baseline in mean spine-specific activity limitation
Time frame: 3 months
Mean change from baseline in mean maximum walking distance
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
- Results publication: PubMed 29499383Pauwels C, Roren A, Gautier A, Linieres J, Rannou F, Poiraudeau S, Nguyen C. Home-based cycling program tailored to older people with lumbar spinal stenosis: Barriers and facilitators. Ann Phys Rehabil Med. 2018 May;61(3):144-150. doi: 10.1016/j.rehab.2018.02.005. Epub 2018 Feb 27.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Christelle Nguyen, MD, PhD principal investigator
A_HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 8 Mar 2018. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barriers to home-based cycling (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT03325309, 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 8 Mar 2018.