Feasibility of Prehab for Lumbar Spinal Stenosis

NCT05073081 | Completed DMC

• 1 other identifier: Prehab LSS
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 4

Brief Summary

The literature has shown evidence of the effectiveness of prehabilitation programs on post-operative recovery for musculoskeletal conditions; however, evidence for prehabilitation for lumbar spinal stenosis (LSS) is limited. Investigators have found that there is very low to low quality evidence for the effect of prehabilitation interventions for improving outcomes following lumbar spine surgery. Therefore, the purpose of this study will be to determine the feasibility of a prehabilitation program for patients undergoing LSS surgery, and pilot test the protocol to provide the foundation for future design of a larger, multicenter randomized controlled trial.

Conditions

Lumbar Spinal Stenosis; Prehabilitation

Keywords

Prehabilitation; Spinal stenosis; Surgery; Exercise therapy

Outcome Measures

Primary Outcomes (6)

• Patient Adherence

  Measured by patient diary, app-based program 1. Proceed with study if 80% of participants attended all 4 exercise sessions 2. Proceed with study if 60% of participants report exercise at last 3x/week.

  During the 8-week Intervention

• Recruitment Rate

  Proceed with study if 50% of eligible participants consent to participate within 4 months

  20 weeks before LSS surgery

• Content Acceptability

  Measured using a survey administered at the end of the 8-week intervention 1. Proceed with the study if 60% found treatment useful (\>7/10 on a Likert scale) 2. Proceed with the study if 60% found treatment helpful (\>7/10 on a Likert scale)

  Immediately after the intervention (8-weeks)

• Format Acceptability

  Measured using a survey administered at the end of the 8-week intervention 1. Proceed with the study if 60% found treatment delivery acceptability (\>7/10 on a Likert scale) 2. Proceed with the study if 60% of participants reported being likely to recommend this treatment (\>7/10 on a Likert scale) 3. Proceed with the study if 60% reported being likely to use this treatment again (\>7/10 on a Likert scale)

  Immediately after the intervention (8-weeks)

• Follow-up

  1. Proceed with the study if 90% of participants follow-up at the end of the prehab intervention 2. Proceed with the study if 85% of participants follow-up at 6 months 3. Proceed with the study if 85% of participants follow-up at 12 months 4. Proceed with the study if 60% reported being likely to use this treatment again (\>7/10 on a Likert scale)

  Immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

• Burden

  Proceed with the study if 60% reported being likely to use this treatment again (\>7/10 on a Likert scale)

  Immediately after the intervention (8-weeks)

Secondary Outcomes (9)

• The Oswestry Disability Index

  20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

• Swiss Spinal Stenosis Questionnaire - Balance

  20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

• SF-12

  20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

• Patient Health Questionnaire-9

  20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

• Pain Catastrophizing Scale

  20 weeks before LSS surgery, immediately after the intervention (8-weeks), 3-, and 12-months post-operatively

Study Arms (2)

Prehabilitation

EXPERIMENTAL

The 8-week prehabilitation program will be delivered online using synchronous and asynchronous sessions delivered by either a physiotherapist, chiropractor or kinesiologist. There will be 4 individual exercises sessions delivered synchronously using Zoom or Physitrack in which motivational interviewing and graded activity exercises will be conducted. Participants will also be asked to exercise at least 3 times a week using the asynchronous exercise videos. The exercises will be individualized on participants functional ability and personal goals identified at baseline, with a focus on muscle strengthening, stretching, improving spinal flexibility and stability. There will be a booster session at 6-weeks post-op. Participants will also undergo 5 group educational sessions, which will provide information regarding: goal setting, pain education, self-management, pacing, post-operative expectations, exercise recommendations, and information regarding their upcoming surgery.

Other: Prehab for LSS

Usual Care

ACTIVE COMPARATOR

Participants in the control group will receive usual care as per surgeons' current practice. This generally consists of one session with an anesthesiologist, a nurse and access to our online videos.

Other: Usual Care

Interventions

Prehab for LSS OTHER

The 8-week prehabilitation program will be delivered online by physiotherapists, chiropractors, and kinesiologists through synchronous and asynchronous exercise sessions, along with online educational sessions.

Prehabilitation

Usual Care OTHER

Participants in the control group will receive usual care as per surgeons' current practice.

Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Minimum 20 weeks prior to date of LSS surgery
• Older than 55 years of age
• Scheduled for first spinal surgery
• Can read and understanding English, with no significant visual or hearing impairment that would require additional support

You may not qualify if:

• Known or suspected pathology (e.g., cancer, cauda equina syndrome)
• Unable to engage in exercise due to other comorbidities
• No access to the Internet

Sponsors & Collaborators

• McMaster University: lead
• University of Calgary: collaborator
• University of Alberta: collaborator

Study Sites (4)

University of Calgary

Calgary, Alberta, Canada

Location

University of Toronto

Toronto, Ontario, Canada

Location

University of Alberta

Edmonton, Canada

Location

McMaster University

Hamilton, Canada

Location

MeSH Terms

Conditions

Spinal Stenosis

Interventions

lanosterol synthase

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Luciana G Macedo, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Doug Gross, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Lisa Carlesso, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Kenneth Thomas, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and those delivering the intervention is not possible within rehabilitation trials and blinding of assessors is not possible when participants are not blinded, and outcomes are self-reported. Research coordinators involved in data collection and researchers involved in data analysis, however, will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a mixed methods two-armed pilot RCT evaluating an 8-week virtual prehabilitation program for participants undergoing LSS surgery versus usual care. A longitudinal qualitative study will be conducted parallel to the pilot RCT.

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 11, 2021
• Study Start: December 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available following publication of the results, and kept for at least 5 years to allow for the publication of findings.
• Access Criteria: Ethics approval will be required for any secondary analysis of data as per HiREB approval.

Locations

CA (4)