Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients with Lumbar Spinal Stenosis

NCT ID: NCT05513326

Last Updated: 2025-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-26

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Spinal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention Group

Intervention group will received education and a specific rehabilitation program (exercises).

Group Type EXPERIMENTAL

Exercises and education

Intervention Type OTHER

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.

Control Group

Control group will received education alone.

Group Type OTHER

Education alone

Intervention Type OTHER

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.

Interventions

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Exercises and education

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.

Intervention Type OTHER

Education alone

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Université du Québec à Trois-Rivières

OTHER

Sponsor Role lead

Responsible Party

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Martin Descarreaux

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Mariève Houle, PhD(c)

Role: CONTACT

819 376-5011 ext. 3969

Facility Contacts

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Mariève Houle, PhD (c)

Role: primary

819 376-5011 ext. 3969

References

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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.

Reference Type DERIVED
PMID: 36572884 (View on PubMed)

Other Identifiers

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UQTR-2022-program

Identifier Type: -

Identifier Source: org_study_id

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