Prehabilitation + Education for Shoulder Replacement Surgery

(PREPS Trial)

Overseen By Katrina Munro

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Disqualifiers: Hemi-arthroplasty, Contraindications to exercise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Shoulder problems affect many Canadians yearly. While surgery is one of the best treatments for shoulder problems, patients are unaware about shoulder replacement surgeries, the exercises needed after surgery and how to safely recover from the surgery without having another injury. Uncertainties about the surgery and recovery process can further cause post-surgery problems such as: pain, anxiety and re-injury. While some healthcare centers offer an in- class program to educate patients before surgery, some patients face issues with distance or transportation, and cannot regularly meet their doctor to address all their concerns. This project aims to create an online educational program that will teach patients through online videos and educational materials before they go into shoulder replacement surgery. By creating online modules, it can increase the accessibility for home use, and prepare patients on topics such as: their concerns about the surgery and proper exercises they can expect after surgery for a safe recovery. The aim is to study three groups of patients before surgery; 1. a group consisting of an online pre-rehabilitation program 6 weeks before surgery, 2. a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist or 3. A group consisting of the current standard of care, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist. Researchers will monitor all groups on their recovery before and after surgery. This will provide another alternative to informing patients before surgery and help them to prepare better for surgery. The online modules will contribute to improving the care in Southern Ontario and eventually be used for future care across Canada.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Preoperative Rehabilitation and Education Program for shoulder replacement surgery?

Research suggests that a well-designed rehabilitation program is crucial for successful outcomes after shoulder replacement surgery. Early rehabilitation and education can help patients understand the recovery process and improve their physical therapy results, leading to better overall recovery. ^{1 2 3 4 5}

How is the Preoperative Rehabilitation and Education Program treatment different from other treatments for shoulder replacement surgery?

This treatment is unique because it combines prehabilitation (pre-surgery exercises) and education to prepare patients physically and mentally for shoulder replacement surgery, aiming to improve recovery and reduce risks, unlike standard treatments that may not include these preparatory components. ^{1 6 7 8 9}

Research Team

Joy MacDermid, PhD

Principal Investigator

Western University, Canada

Eligibility Criteria

This trial is for English-speaking adults over 18 who are scheduled for total shoulder replacement surgery at HULC in no less than 9 weeks and can commit to the study for a year post-surgery. It's not suitable for those with exercise contraindications or those having hemi-arthroplasty.

Inclusion Criteria

Able to provide informed consent

I am over 18 years old.

Speaks and reads in English unless can provide a translator

Exclusion Criteria

I have agreed to undergo partial joint replacement surgery.

Any contraindications to exercise

I agreed to join the study less than 8 weeks before my surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Education and Rehabilitation

Participants undergo a 6-week online pre-rehabilitation and education program before surgery

6 weeks

Online modules

Surgery

Participants undergo total shoulder arthroplasty surgery

Follow-up

Participants are monitored for recovery and outcomes post-surgery

12 months

Assessments at 6 weeks, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• Preoperative Rehabilitation and Education Program

Trial Overview The study tests an online pre-rehabilitation program (PREPS) against the standard WebEx class led by therapists before shoulder replacement surgery. One group gets PREPS, another PREPS plus therapy, and a third follows current standard care.

Participant Groups

Group I: Online only Experimental Treatment 1 Intervention

a group consisting of an online pre-rehabilitation program 6 weeks before surgery

Group II: Online and PT Experimental Treatment 1 Intervention

a group consisting of an online pre-rehabilitation program 6 weeks before surgery + therapist

Group III: Standard of Care Group Active Control 1 Intervention

A group consisting of the current standard of care at HULC, which is a WebEx pre-operative education class lead by a physiotherapist and occupational therapist.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Western University, Canada

Collaborator

Trials

270

Recruited

62,500+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Findings from Research

Anatomic total shoulder arthroplasty patients using a neutral rotation sling position experienced less night pain and improved range of motion, supported by moderate evidence from the review of 14 studies.

The review highlighted that many factors influencing treatment outcomes, such as telemedicine and immediate range of motion exercises, had only preliminary or conflicting evidence, indicating a need for more standardized and high-quality research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with better treatment outcome of physical therapy interventions after shoulder arthroplasty: A systematic review. Claes, A., Mertens, MG., Verborgt, O., et al.[2022]

Preoperative scapular rehabilitation significantly reduced pain and improved shoulder function in patients undergoing arthroscopic repair for rotator cuff injuries, with notable benefits observed after one year.

Patients who received scapular rehabilitation showed greater improvements in shoulder abduction and overall quality of life compared to those who did not, indicating that targeted preoperative exercises can enhance recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Operative Scapular Rehabilitation for Arthroscopic Repair of Traumatic Rotator Cuff Tear: Results of a Randomized Clinical Trial. de Almeida, LL., Mendes Júnior, AF., Neto, JDM., et al.[2022]

A systematic review of 33 studies involving 3167 citations found that prehabilitation did not significantly improve postoperative function, quality of life, or pain in patients undergoing knee or hip arthroplasty for osteoarthritis.

However, prehabilitation programs lasting over 500 minutes may reduce the need for postoperative rehabilitation, indicating a potential benefit in healthcare utilization, even though no significant reductions in readmissions or nursing home placements were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. Cabilan, CJ., Hines, S., Munday, J.[2022]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Balancing clinician and patient priorities for total shoulder replacement preoperative education programs. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of early versus delayed rehabilitation following total shoulder replacement: A systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Factors associated with better treatment outcome of physical therapy interventions after shoulder arthroplasty: A systematic review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation Strategies After Shoulder Arthroplasty in Young and Active Patients. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Speed of recovery of the most commonly performed shoulder surgeries. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pre-Operative Scapular Rehabilitation for Arthroscopic Repair of Traumatic Rotator Cuff Tear: Results of a Randomized Clinical Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

What moves patients to participate in prehabilitation before major surgery? A mixed methods systematic review. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Costs and quality of life for prehabilitation and early rehabilitation after surgery of the lumbar spine. [2019]

9. Australia pubmed.ncbi.nlm.nih.gov

The effectiveness of prehabilitation or preoperative exercise for surgical patients: a systematic review. [2022]