PREPARE Trial: a Parallel Arm Multicenter Randomized Trial of Frailty-focused PReoperative Exercise to Decrease PostoperAtive Complications Rates and Disability scorEs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 850
- Locations
- 1
- Primary Endpoint
- In-hospital complications
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Group allocation will not be indicated in data analyzed by the outcome assessors.
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Exercise Group (Behavioral)
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.
Outcomes
Primary Outcomes
In-hospital complications
Time Frame: up to 30 days.
The Postoperative Morbidity Survey (POMS), will be used to define complications. Individuals experiencing any POMS complication or dying in hospital will be said to have experienced a complication.
Patient-reported disability 30 days after surgery
Time Frame: Assessing change in score from baseline data collection to 30 days post-op
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) will be used . It is a patient-reported disability scale that assesses limitations in six major life domains - cognition, mobility, self-care, social interaction, life activities and participation in society. Participants will report if they have had no difficulty, mild difficulty, moderate difficulty, severe difficulty or extreme difficulty (simply cannot do) with the items listed.
Secondary Outcomes
- Health System - Emergency department visits(365 days post-op)
- Function - Falls(Assessing the difference in the occurrence of falls between the exercise group and control group on day 3, 5, 7, up to 30 days, as well as 30-day, 90-day and one-year after surgery.)
- Function - 5 Times Sit to Stand(Assessing change in score from baseline data collection up to 30 days post-op.)
- Health System - Long-term care admissions(30, 90, and 365 days post-op via telephone)
- Health-related quality of life(Assessing any change from baseline to 30, 90 and 365 days post-op.)
- Health System - Hospital re-admissions(30, 90, and 365 days post-op via telephone)
- Function - Daily and total step count(Assessing the difference in daily and total step count between the exercise group and control group for 30 days post-op.)
- Function - Katz Index of Activities of Daily Living(Assessing change in the participants KATZ ADL score from baseline to post-op day 3, 5, 7 and up to 30 days.)
- All-cause mortality(30, 90, and 365 days.)
- Health System - Discharge disposition(Up to 30 days post-op.)
- Participant Feedback(Participants are asked to reflect on the program during a call the day before surgery.)
- Safety (Adverse Events)(Assessing frequency of, or change in any safety events from enrollment up to 30 days post-op in hospital between the exercise group and control group.)