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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02258672
Other study ID # UQTR-CSSSTR 2014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2014
Est. completion date March 1, 2020

Study information

Verified date March 2020
Source Université du Québec à Trois-Rivières
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the present study is to evaluate the effectiveness of a prehabilitation program on the recovery of patients undergoing a minimally invasive surgery for degenerative lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two groups; intervention or control group. Participants in the intervention group will take part in a physical training program, three times a week for six weeks before undergoing surgery. The exercise program will be supervised and will aim at improving core muscles strength and endurance as well as spine stability. It is hypothesized that the prehabilitation program will significantly improve disability and pain intensity reported by patients after surgery. Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but its results may also impact the management of patients awaiting spine surgery for various conditions.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

To be affected by degenerative lumbar spinal stenosis and to be awaiting minimally invasive surgery for the lumbar spinal stenosis

Exclusion Criteria:

Non-degenerative spinal stenosis, arthritic conditions (except for facet arthrosis), impaired cognitive function, spinal instability and disagreement from the treating neurosurgeon for the patient to take part in the preadaptation programme.

Study Design


Intervention

Other:
Prehabilitation program
Progressive and individualized physical training aimed at improving core muscles strength and endurance as well as spinal stability.

Locations

Country Name City State
Canada Université du Québec à Trois-Rivières Trois-Rivières Quebec

Sponsors (3)

Lead Sponsor Collaborator
Université du Québec à Trois-Rivières Fonds de soutien au démarrage de projets en collaboration (CSSSTR), Fonds pour la Recherche Clinique de l'UQTR

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in disability Oswestry Disability Index baseline, week 6, week 10, week 18, week 30
Secondary Change from Baseline in pain intensity Visual Analog Scale baseline, week 6, week 10, week 18, week 30
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