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

NCT05513326 | Recruiting

• 1 other identifier: UQTR-2022-program
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Spinal Stenosis; Neurogenic claudication; Walking capacity; Exercises; Education; gait pattern characteristics

Outcome Measures

Primary Outcomes (1)

• Change from baseline in walking capacity

  Walking capacity measure with the Self-Paced Walking Test (time)

  Baseline, week 2, week 4, week 6, week 12

Secondary Outcomes (10)

• Change from baseline in leg and back pain intensity

  Baseline, week 2, week 4, week 6, week 12

• Change from baseline in lumbar spinal stenosis related disabiltity

  Baseline, week 6, week 12

• Changes from baseline in self-efficacy

  Baseline, week 6, week 12

• Change from baseline in anxiety and depression

  Baseline, week 6, week 12

• Change from baseline in physical activity level

  Baseline, week 6, week 12

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: Exercises and education

Control Group

OTHER

Control group will received education alone.

Other: Education alone

Interventions

Exercises and education 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.

Intervention Group

Education alone 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.

Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Université du Québec à Trois-Rivières: lead

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G8Z 4M3, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 36572884 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Motor Activity

Interventions

Exercise; Educational Status

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics

Central Study Contacts

Mariève Houle, PhD(c)

CONTACT

819 376-5011; marieve.houle@uqtr.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: August 24, 2022
• Study Start: January 26, 2023
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

CA (1)