Spinal StenosisNCT05513326
Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients With Lumbar Spinal Stenosis
A study testing Exercises and education and Education alone in people with Spinal Stenosis, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial summary
The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spinal Stenosis
- What is being tested?
- Exercises and education and Education alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 26 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- 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
Who may be able to join
- being at least 50 years old
- having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging
- having NC associated with LSS
- being able to speak and understand French
- being willing to attend 3 intervention sessions per week
- with a duration of signs and symptoms of at least 3 months
- (7) being able to walk at least 20 meters without walking aid, but not being able to walk continuously for 30 minutes
- being able to provide informed written consent.
Who cannot join
- congenital LSS,
- symptomatic osteoarthritis (hip or knee) causing limited walking capacity
- neurological disease affecting walking capacity such as Parkinson
- uncontrolled diabetes
- heart failure
- intermittent claudication of vascular origin
- impaired cognitive capacity
- back or lower extremities surgery in the past 3 months
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, G8Z 4M3
About this study
Official title: Effectiveness of a 6-week Specific Rehabilitation Program Combining Education and Exercises on Walking Capacity in Patients With Lumbar Spinal Stenosis With Neurogenic Claudication
The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC.
The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.
- Conditions
- Spinal Stenosis
- Being tested
- Exercises and education, Education alone
- Keywords
- Spinal Stenosis, Neurogenic claudication, Walking capacity, Exercises, Education, gait pattern characteristics
- Medical subject headings
- Spinal Stenosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercises and educationOther
Exercises: 3 training sessions per week that will last for 30 minutes. Sessions will start with 5 minutes of activation (walking on a treadmill or cycling). Then, participants will be asked to complete 5 exercises targeting lower limb strengthening (time: 18 minutes) followed by 2 exercises designed to improve balance and 3 stretching exercises for the lower limb (time: 7 minutes).
Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.
Education aloneOther
Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Intervention group will received education and a specific rehabilitation program (exercises). Receives: Other: Exercises and education |
| Control Group | Other | Control group will received education alone. Receives: Other: Education alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in walking capacity
Walking capacity measure with the Self-Paced Walking Test (time)
Measured: Baseline, week 2, week 4, week 6, week 12
Secondary outcomes (10)
Change from baseline in leg and back pain intensity
Leg and back pain intensity will be independently assessed using a 11-point numerical rating scale (from 0 to 10 points). Higher score indicates higher pain.
Measured: Baseline, week 2, week 4, week 6, week 12
Change from baseline in lumbar spinal stenosis related disabiltity
Lumbar spinal stenosis related disability is measured with the French-Canadian version of the Swiss Spinal Stenosis Questionnaire. Pain, function and satisfaction related to lumbar spinal stenosis. Pain subscale score range from 7 to 35 with higher values indicate a worst outcome, Function subscale score range from 5 to 20 with higher values indicate a worst outcome, Satisfaction subscale score range from 6 to 24 with higher values indicate a worst outcome. The total score is composed of the three subscales and range from 18 to 79.
Measured: Baseline, week 6, week 12
Changes from baseline in self-efficacy
Measured with Self-efficacy measured with the French-Canadian Chronic Pain Self-Efficacy Scale. Each question is rated on a numerical scale (from 1 to 10). Total is calculated using the mean of the 33-items scores and ranges from 1 to 10 with a higher score indicate higher self-efficacy.
Measured: Baseline, week 6, week 12
Change from baseline in anxiety and depression
Measured with the French-Canadian adaptation of the Hospital Anxiety and Depression Scale. Total score range from 0 to 21 with higher score indicating symptoms of anxiety and/or depression.
Measured: Baseline, week 6, week 12
Change from baseline in physical activity level
Physical activity level assessed with the [Physical Activity Questionnaire for the Elderly]. The questionnaire allows to place participants into one of the 3 categories (low, moderate or high physical activity level). Physical activity level is measured in time per day.
Measured: Baseline, week 6, week 12
Patient's global impression of change
Global impression of change will be measured using a 7-point scale that ranges from 'very much improved' to 'very much worse' with 'no change' as the mid-point.
Measured: changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12)
Change from baseline in biomechanical parameters of gait
Spatio-temporal parameters of gait measured with wearable inertial sensors (velocity (m/s))
Measured: Baseline, week 2, week 4, week 6, week 12
Change from baseline in biomechanical parameters of gait
Spatio-temporal parameters of gait measured with wearable inertial sensors measured in meters (stride length, swing witdh, toe clearance)
Measured: Baseline, week 2, week 4, week 6, week 12
Change from baseline in biomechanical parameters of gait
Spatio-temporal parameters of gait measured with wearable inertial sensors measured in % (walking phases, assymetry, variability)
Measured: Baseline, week 2, week 4, week 6, week 12
Change from baseline in lower extremity physical function and balance
Lower extremity physical function and balance measured with the Short Physical Performance Battery. Total score ranges from 0 to 12 with higher score indicating a better lower extremity physical function and balance.
Measured: Baseline, week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2022
- Study start26 Jan 2023
- Primary completion30 Sep 2025
- Study completion31 Dec 2025
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 Spinal StenosisStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Descarreaux, Université du Québec à Trois-Rivières
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05513326
- Sponsor's protocol ID
- UQTR-2022-program
- Status last verified
- May 2026
- First submitted
- 7 Jul 2022
- Last updated
- 11 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Houle M, Tetreau C, Chatillon CE, Marchand AA, Descarreaux M. Effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with lumbar spinal stenosis with neurogenic claudication: a randomized controlled clinical trial protocol. Trials. 2022 Dec 27;23(1):1046. doi: 10.1186/s13063-022-07011-3.
PubMed 36572884
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a 6-week Specific Rehabilitation Program Combining Education and Exercises on Walking Capacity in Patients With Lumbar Spinal Stenosis With Neurogenic Claudication
- ClinicalTrials.gov ID
- NCT05513326
- Acronym / sponsor ID
- UQTR-2022-program
- Conditions
- Spinal Stenosis
- Keywords
- Spinal Stenosis, Neurogenic claudication, Walking capacity, Exercises, Education, gait pattern characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- 26 Jan 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Aug 2022 (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 aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC.
The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Exercises and educationIntervention group will received education and a specific rehabilitation program (exercises). |
| Control Group | Other | Other: Education aloneControl group will received education alone. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- being at least 50 years old
- having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging
- having NC associated with LSS
- being able to speak and understand French
- being willing to attend 3 intervention sessions per week
Key exclusion criteria (8 listed)
- congenital LSS,
- symptomatic osteoarthritis (hip or knee) causing limited walking capacity
- neurological disease affecting walking capacity such as Parkinson
- uncontrolled diabetes
- heart failure
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 |
|---|---|---|
| Exercises and educationExercises: 3 training sessions per week that will last for 30 minutes. Sessions will start with 5 minutes of activation (walking on a treadmill or cycling). Then, participants will be asked to complete 5 exercises targeting lower limb strengthening (time: 18 minutes) followed by 2 exercises designed to improve balance and 3 stretching exercises for the lower limb (time: 7 minutes). Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions. | Other | Intervention Group |
| Education aloneEducation: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions. | Other | Control Group |
Primary outcome
Change from baseline in walking capacity
Time frame: Baseline, week 2, week 4, week 6, week 12
Walking capacity measure with the Self-Paced Walking Test (time)
10 secondary outcomes
Change from baseline in leg and back pain intensity
Time frame: Baseline, week 2, week 4, week 6, week 12
Change from baseline in lumbar spinal stenosis related disabiltity
Time frame: Baseline, week 6, week 12
Changes from baseline in self-efficacy
Time frame: Baseline, week 6, week 12
Change from baseline in anxiety and depression
Time frame: Baseline, week 6, week 12
Change from baseline in physical activity level
Time frame: Baseline, week 6, week 12
Patient's global impression of change
Time frame: changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12)
Change from baseline in biomechanical parameters of gait
Time frame: Baseline, week 2, week 4, week 6, week 12
Change from baseline in biomechanical parameters of gait
Time frame: Baseline, week 2, week 4, week 6, week 12
Change from baseline in biomechanical parameters of gait
Time frame: Baseline, week 2, week 4, week 6, week 12
Change from baseline in lower extremity physical function and balance
Time frame: Baseline, week 6, week 12
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 11 May 2026.
- Derived from this study: PubMed 36572884Houle M, Tetreau C, Chatillon CE, Marchand AA, Descarreaux M. Effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with lumbar spinal stenosis with neurogenic claudication: a randomized controlled clinical trial protocol. Trials. 2022 Dec 27;23(1):1046. doi: 10.1186/s13063-022-07011-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises and education and Education alone in people with Spinal Stenosis, run by Université du Québec à Trois-Rivières at 1 site in Canada.
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 8 inclusion and 8 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 11 May 2026. 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 Canada. 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?
Change from baseline in walking capacity (time frame: Baseline, week 2, week 4, week 6, week 12). 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 NCT05513326, 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 11 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.