The PREPARE Trial: Exercise Before Surgery to Improve Recovery in Older People With Frailty

NCT ID: NCT04221295

Last Updated: 2024-08-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-24
• Study Completion Date: 2025-05-30

Brief Summary

This study evaluates whether participating in a home-based exercise program leads to lower levels of complication rates and patient-reported disability after surgery. Half of the participants will be randomized into the exercise group, while the other half will be randomized into the control group.

Detailed Description

Background: Four out of ten older people having surgery live with frailty, leaving them vulnerable to adverse outcomes due to accumulation of age- and disease-related deficits. An increasing number of people with frailty require surgery. Frailty is associated with a >2-fold increase in complications and new patient-reported disability; absolute rates are >50% and 20% respectively; physical and physiologic deficits are particularly implicated. Mortality, costs and institutionalization after surgery are also significantly associated with frailty.

Despite frailty's strong association with adverse outcomes, few perioperative trials include older people with frailty. Exercise therapy may improve function and decrease complications for other people with frailty by addressing physical and physiologic deficits. However, existing trials are small (median n=54) and single center. Most interventions have been resource-intensive, requiring attendance at hospital-based sessions, which may limit access to many who could benefit. Patient-reported outcomes are also lacking. Therefore, a multicenter trial of home-based exercise therapy before surgery for older people with frailty, powered to address patient-reported outcomes, is needed. Our trial will address these knowledge gaps by testing the effectiveness of home-based preoperative exercise (exercise prehabilitation) in decreasing patient-reported disability and postoperative complications in older people with frailty having major surgery.

Research aims: Estimate the effectiveness of exercise prehabilitation on:

• Co-primary outcomes: patient-reported disability 30-days after surgery and in-hospital complications
• Secondary outcomes: patient-centered (discharge home, survival, 30, 90 and one-year disability scores, quality of life, function) and system-relevant (length of stay, admissions)
• Health economic outcomes: costs, cost-effectiveness

Methods:

Design, setting and participants: Parallel-arm multicenter randomized controlled trial at 11 Canadian hospitals. People => 60 years old with frailty (Clinical Frailty Scale score of 4/9) having major elective non-cardiac surgery (vascular, intrathoracic, intraabdominal, pelvic, ENT) with expected length of stay of => 2 days will be included.

Intervention: Home-based exercise program with demonstrated efficacy, feasibility and acceptability tailored for people with frailty.

Outcomes and sample size: Co-primary outcomes are patient-reported disability 30 days after surgery (validated WHODAS tool) and prospectively collected in-hospital complications (validated POMS tool). 750 participants (375/arm) will provide 98% power for disability (control mean score 35 (SD 25; MID=8)) and 90% power for complications (55% complication rate (25% relative risk reduction)) (α=0.025; 2 pair-wise comparisons).

Due to surgical delays and cancellations as a result of the COVID-19 pandemic, our trial sample size has seen more participants having surgery outside of their expected time to operation than originally predicted. To account for this, and to ensure adequate power for our analyses, our final sample size will be increased to 850 participants.

Expertise: Our team features multidisciplinary clinical and methodological experts, nationally representative knowledge users and patient representatives.

Expected outcomes: Older people with frailty are a growing and vulnerable segment of the surgical population and are under-represented in existing studies. Exercise prehabilitation is a high-priority research question which may be most relevant to people with frailty given their physical and physiologic vulnerabilities. This study, featuring patient-reported outcomes and an integrated knowledge translation approach will produce generalizable findings directly relevant to patients, families, caregivers, and knowledge users.

Conditions

Frailty; Surgery--Complications; Disability Physical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise Group

The intervention is a home-based, multimodal exercise prehabilitation program. Exercise is prescribed in one-hour sessions, performed a minimum of three times per week for three weeks, consisting of: 1) strength training, 2) aerobic exercise and 3) flexibility. The intervention group will receive weekly phone calls to gauge adherence, suggest modifications, provide support and track any adverse events.

Group Type: EXPERIMENTAL

Exercise Group

Intervention Type: BEHAVIORAL

Previously described in the arm/group descriptions.

Control Group

The control group will receive the World Health Organization recommendations for physical activity for people greater or equal to the age of 65 years old pamphlet, as well as a guide to healthy eating for older adults.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise Group

Previously described in the arm/group descriptions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 60 years of age or older
• Elective surgery with expected post-surgery stay of 2 days or more.
• Frailty present (Clinical Frailty Scale (CFS) score of 4/9 or greater)
• Surgery date between 3 and 12 weeks from enrollment

Exclusion Criteria

• Inability to speak English or French
• Co-morbidity preventing assessment or understanding of questionnaires
• Unable to be contacted by telephone
• Unwilling to participate in exercise program
• Cardiac, neurological or orthopedic procedure
• Palliative surgery
• Certain cardiovascular conditions

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel I McIsaac, MD,MPH,FRCPC

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Research Institute

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

References

McIsaac DI, Fergusson DA, Khadaroo R, Meliambro A, Muscedere J, Gillis C, Hladkowicz E, Taljaard M; PREPARE Investigators. PREPARE trial: a protocol for a multicentre randomised trial of frailty-focused preoperative exercise to decrease postoperative complication rates and disability scores. BMJ Open. 2022 Aug 8;12(8):e064165. doi: 10.1136/bmjopen-2022-064165.

Reference Type: DERIVED

PMID: 35940835 (View on PubMed)

Other Identifiers

20190409-01T

Identifier Type: -

Identifier Source: org_study_id