NCT02258672

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 7, 2014

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

5.4 years

First QC Date

October 2, 2014

Last Update Submit

March 24, 2020

Conditions

Keywords

Preoperative rehabilitationMinimally invasive surgeryFunctional capacity

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in disability

    Oswestry Disability Index

    baseline, week 6, week 10, week 18, week 30

Secondary Outcomes (1)

  • Change from Baseline in pain intensity

    baseline, week 6, week 10, week 18, week 30

Study Arms (2)

Prehabilitation program

EXPERIMENTAL

Participants will be physically trained before undergoing surgery

Other: Prehabilitation program

Control

NO INTERVENTION

Patients will follow the normal course of care provided by the hospital

Interventions

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

Prehabilitation program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université du Québec à Trois-Rivières

Trois-Rivières, Quebec, G9A 5H7, Canada

Location

Related Publications (1)

  • Marchand AA, Suitner M, O'Shaughnessy J, Chatillon CE, Cantin V, Descarreaux M. Effects of a prehabilitation program on patients' recovery following spinal stenosis surgery: study protocol for a randomized controlled trial. Trials. 2015 Oct 27;16:483. doi: 10.1186/s13063-015-1009-2.

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Martin Descarreaux, DC, PhD

    Université du Québec à Trois-Rivières

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DC, PhD

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 7, 2014

Study Start

October 1, 2014

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations