Lumbar Spinal StenosisNCT07861334
EFFECTS OF EXERCISE AND EXERCISE COUNSELLING IN PATIENTS WITH LUMBAR SPINAL STENOSIS
A study testing Individualized Multimodal Exercise and Exercise-Counselling Program in people with Lumbar Spinal Stenosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Lumbar spinal stenosis is a condition in which narrowing of the spinal canal can cause pain, neurogenic claudication, reduced walking ability, and limitations in daily activities. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Individualized Multimodal Exercise and Exercise-Counselling Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSlovenia
- Study dates
- 14 Sep 2024to 21 Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-80 years
- Diagnosis of LSS confirmed by magnetic resonance imaging (MRI)
- Clinical symptoms associated with LSS (neurogenic claudication)
- Ability to walk at least 250 m
- Placement on the waiting list for LSS surgery with an expected waiting time > 1 year
Who cannot join
- Early onset of symptoms
- High-grade spondylolisthesis
- Vascular claudication
- Diabetic polyneuropathy
- Neurological disease affecting functional capacity
- Fibromyalgia or systemic inflammatory diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF EXERCISE AND EXERCISE COUNSELLING IN PATIENTS WITH LUMBAR SPINAL STENOSIS: A RANDOMISED CONTROLLED TRIAL
Lumbar spinal stenosis is a condition in which narrowing of the spinal canal can cause pain, neurogenic claudication, reduced walking ability, and limitations in daily activities. This study evaluated whether a 12-week structured, individually adapted exercise and exercise-counselling program could improve symptoms and physical function in patients with lumbar spinal stenosis.
Participants were randomly assigned to either an exercise group or a control group. The exercise group took part in supervised exercise sessions twice weekly for 12 weeks. The program included individually adapted exercises, treadmill walking, a progressive walking program with daily recording of walking distance or step count, and exercises to be performed independently at home. The control group continued with their usual lifestyle during the same period.
Outcomes were assessed at baseline, after 8 weeks, and after 12 weeks. The main outcomes were disability related to lumbar spinal stenosis, assessed with the Oswestry Disability Index, and walking capacity, assessed with the 6-minute walk test. Additional outcomes included pain, trunk muscle endurance, flexibility, balance, lumbar spinal stenosis-related symptoms and physical function, and health-related quality of life.
Read the detailed description
This prospective, randomized, controlled clinical study was designed to evaluate the effects of a structured, individually adapted 12-week exercise and exercise-counselling intervention in patients with lumbar spinal stenosis and neurogenic claudication. Participants were randomly allocated to an experimental group or a control group.
The intervention consisted of supervised exercise sessions twice weekly for 12 weeks under the guidance of a kinesiologist. The program combined individually adapted exercise, treadmill walking, a progressive walking program, daily recording of walking distance or step count, and exercises performed independently in the home environment. The control group continued with their usual lifestyle during the 12-week study period.
Assessments were performed at baseline, after 8 weeks, and after 12 weeks. The primary study objectives were to evaluate whether the intervention reduced disability related to lumbar spinal stenosis and improved walking capacity. Disability was assessed using the Oswestry Disability Index, and walking capacity was assessed using the 6-minute walk test.
Secondary assessments included pain intensity, trunk muscle endurance, flexibility, health-related quality of life, balance, and lumbar spinal stenosis-related symptom severity and physical function. The study also examined whether a progressive walking program combined with exercise could increase walking tolerance before the onset of neurogenic claudication.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Individualized Multimodal Exercise and Exercise-Counselling Program
- Keywords
- lumbar spinal stenosis; neurogenic claudication; exercise therapy; walking capacity; disability; rehabilitation
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Multimodal Exercise and Exercise-Counselling ProgramBehavioural
A 12-week multimodal intervention consisting of supervised individualized exercise twice weekly, treadmill walking twice weekly, a progressive walking program with daily recording of walking distance or step count, home-based exercises, and individualized exercise counselling. The program was adapted to participants' symptoms, functional capacity, and progress. Exercise counselling included guidance on progression of walking, management of symptoms during activity, adherence to home exercise, and strategies for maintaining physical activity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group - Individualized Multimodal Exercise Program | Experimental | Participants assigned to the experimental group completed a 12-week individualized multimodal exercise and exercise-counselling program. The program included supervised exercise under the guidance of a kinesiologist twice weekly, treadmill walking twice weekly, daily walking with recording of walking distance or step count, and exercises performed independently at home. Exercise was adapted to the participant's functional status and symptoms. Receives: Behavioral: Individualized Multimodal Exercise and Exercise-Counselling Program |
| Control Group - Usual Care | Active comparator | Participants assigned to the control group continued their usual lifestyle and usual management of lumbar spinal stenosis symptoms during the 12-week study period. Some participants received standard physiotherapy within the public health system and recommendations from an orthopedic specialist regarding additional manual therapy, trunk-stabilization exercises, and aerobic activity according to their abilities. Participants in the control group did not participate in the structured study exercise program or the progressive walking program. Receives: Behavioral: Individualized Multimodal Exercise and Exercise-Counselling Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Disability related to lumbar spinal stenosis was assessed using the Oswestry Disability Index (ODI). The ODI consists of 10 sections addressing pain and limitations in activities of daily living. Scores are converted to a percentage, with higher scores indicating greater disability.
Measured: Baseline, 8 weeks, and 12 weeks
6-Minute Walk Test (6MWT)
Functional walking capacity was assessed using the 6-Minute Walk Test. The outcome was the total distance walked in meters during 6 minutes, with a greater distance indicating better walking capacity.
Measured: Baseline, 8 weeks, and 12 weeks
Secondary outcomes (4)
Visual Analogue Scale (VAS) for Pain
General pain intensity was assessed using a Visual Analogue Scale (VAS). Participants indicated their perceived pain intensity on a 10-cm line ranging from 0, representing no pain, to 10, representing the worst possible pain. Higher scores indicate greater pain intensity.
Measured: Baseline, 8 weeks, and 12 weeks
McGill Torso Muscular Endurance Test Battery
Trunk muscular endurance was assessed using the McGill torso muscular endurance test battery, which included four tests: trunk flexor endurance, right side bridge endurance, left side bridge endurance, and trunk extensor endurance. For each test, the time for which the standardized position could be maintained was recorded in seconds. Longer duration indicates greater muscular endurance.
Measured: Baseline, 8 weeks, and 12 weeks
Sit-and-Reach Test (SART)
Flexibility was assessed using the Sit-and-Reach Test. Two trials were performed and the better result was recorded in centimeters. Higher values indicate greater reach and flexibility.
Measured: Baseline, 8 weeks, and 12 weeks
36-Item Short Form Health Survey (SF-36)
Health-related quality of life was assessed using the 36-Item Short Form Health Survey (SF-36). The questionnaire includes eight health domains and provides two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better perceived health-related quality of life.
Measured: Baseline, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start14 Sep 2024
- Primary completion21 Jun 2025
- Study completion21 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups: an experimental group receiving a 12-week individualized multimodal exercise intervention or a control group continuing their usual lifestyle.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861334
- Sponsor's protocol ID
- KPstudy26
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF EXERCISE AND EXERCISE COUNSELLING IN PATIENTS WITH LUMBAR SPINAL STENOSIS: A RANDOMISED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT07861334
- Acronym / sponsor ID
- KPstudy26
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- lumbar spinal stenosis; neurogenic claudication; exercise therapy; walking capacity; disability; rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 14 Sep 2024 (actual)
- Primary completion
- 21 Jun 2025 (actual)
- Study completion
- 21 Jun 2025 (actual)
- First posted
- 6 Oct 2026 (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.
Lumbar spinal stenosis is a condition in which narrowing of the spinal canal can cause pain, neurogenic claudication, reduced walking ability, and limitations in daily activities. This study evaluated whether a 12-week structured, individually adapted exercise and exercise-counselling program could improve symptoms and physical function in patients with lumbar spinal stenosis.
Participants were randomly assigned to either an exercise group or a control group. The exercise group took part in supervised exercise sessions twice weekly for 12 weeks. The program included individually adapted exercises, treadmill walking, a progressive walking program with daily recording of walking distance or step count, and exercises to be performed independently at home. The control group continued with their usual lifestyle during the same period.
Outcomes were assessed at baseline, after 8 weeks, and after 12 weeks. The main outcomes were disability related to lumbar spinal stenosis, assessed with the Oswestry Disability Index, and walking capacity, assessed with the 6-minute walk test. Additional outcomes included pain, trunk muscle endurance, flexibility, balance, lumbar spinal stenosis-related symptoms and physical function, and health-related quality of life.
Detailed description
This prospective, randomized, controlled clinical study was designed to evaluate the effects of a structured, individually adapted 12-week exercise and exercise-counselling intervention in patients with lumbar spinal stenosis and neurogenic claudication. Participants were randomly allocated to an experimental group or a control group.
The intervention consisted of supervised exercise sessions twice weekly for 12 weeks under the guidance of a kinesiologist. The program combined individually adapted exercise, treadmill walking, a progressive walking program, daily recording of walking distance or step count, and exercises performed independently in the home environment. The control group continued with their usual lifestyle during the 12-week study period.
Assessments were performed at baseline, after 8 weeks, and after 12 weeks. The primary study objectives were to evaluate whether the intervention reduced disability related to lumbar spinal stenosis and improved walking capacity. Disability was assessed using the Oswestry Disability Index, and walking capacity was assessed using the 6-minute walk test.
Secondary assessments included pain intensity, trunk muscle endurance, flexibility, health-related quality of life, balance, and lumbar spinal stenosis-related symptom severity and physical function. The study also examined whether a progressive walking program combined with exercise could increase walking tolerance before the onset of neurogenic claudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups: an experimental group receiving a 12-week individualized multimodal exercise intervention or a control group continuing their usual lifestyle.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group - Individualized Multimodal Exercise Program | Experimental | Behavioral: Individualized Multimodal Exercise and Exercise-Counselling ProgramParticipants assigned to the experimental group completed a 12-week individualized multimodal exercise and exercise-counselling program. The program included supervised exercise under the guidance of a kinesiologist twice weekly, treadmill walking twice weekly, daily walking with recording of walking distance or step count, and exercises performed independently at home. Exercise was adapted to the participant's functional status and symptoms. |
| Control Group - Usual Care | Active comparator | Behavioral: Individualized Multimodal Exercise and Exercise-Counselling ProgramParticipants assigned to the control group continued their usual lifestyle and usual management of lumbar spinal stenosis symptoms during the 12-week study period. Some participants received standard physiotherapy within the public health system and recommendations from an orthopedic specialist regarding additional manual therapy, trunk-stabilization exercises, and aerobic activity according to their abilities. Participants in the control group did not participate in the structured study exercise program or the progressive walking program. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-80 years
- Diagnosis of LSS confirmed by magnetic resonance imaging (MRI)
- Clinical symptoms associated with LSS (neurogenic claudication)
- Ability to walk at least 250 m
- Placement on the waiting list for LSS surgery with an expected waiting time > 1 year
Key exclusion criteria (6 listed)
- Early onset of symptoms
- High-grade spondylolisthesis
- Vascular claudication
- Diabetic polyneuropathy
- Neurological disease affecting functional capacity
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 |
|---|---|---|
| Individualized Multimodal Exercise and Exercise-Counselling ProgramA 12-week multimodal intervention consisting of supervised individualized exercise twice weekly, treadmill walking twice weekly, a progressive walking program with daily recording of walking distance or step count, home-based exercises, and individualized exercise counselling. The program was adapted to participants' symptoms, functional capacity, and progress. Exercise counselling included guidance on progression of walking, management of symptoms during activity, adherence to home exercise, and strategies for maintaining physical activity. | Behavioural | Control Group - Usual Care, Experimental Group - Individualized Multimodal Exercise Program |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: Baseline, 8 weeks, and 12 weeks
Disability related to lumbar spinal stenosis was assessed using the Oswestry Disability Index (ODI). The ODI consists of 10 sections addressing pain and limitations in activities of daily living. Scores are converted to a percentage, with higher scores indicating greater disability.
6-Minute Walk Test (6MWT)
Time frame: Baseline, 8 weeks, and 12 weeks
Functional walking capacity was assessed using the 6-Minute Walk Test. The outcome was the total distance walked in meters during 6 minutes, with a greater distance indicating better walking capacity.
4 secondary outcomes
Visual Analogue Scale (VAS) for Pain
Time frame: Baseline, 8 weeks, and 12 weeks
McGill Torso Muscular Endurance Test Battery
Time frame: Baseline, 8 weeks, and 12 weeks
Sit-and-Reach Test (SART)
Time frame: Baseline, 8 weeks, and 12 weeks
36-Item Short Form Health Survey (SF-36)
Time frame: Baseline, 8 weeks, and 12 weeks
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 6 Oct 2026.
- 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.
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 Individualized Multimodal Exercise and Exercise-Counselling Program in people with Lumbar Spinal Stenosis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 5 inclusion and 6 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 6 Oct 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 Slovenia. 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?
Oswestry Disability Index (ODI) (time frame: Baseline, 8 weeks, and 12 weeks). 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?
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 6 Oct 2026.