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

NCT04221295 | Active Not Recruiting DMC

• 1 other identifier: 20190409-01T
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty; Surgery--Complications; Disability Physical

Outcome Measures

Primary Outcomes (2)

• In-hospital complications

  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.

  up to 30 days.

• Patient-reported disability 30 days after surgery

  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.

  Assessing change in score from baseline data collection to 30 days post-op

Secondary Outcomes (12)

• Function - 5 Times Sit to Stand

  Assessing change in score from baseline data collection up to 30 days post-op.

• 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.

• 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.

• Health-related quality of life

  Assessing any change from baseline to 30, 90 and 365 days post-op.

Study Arms (2)

Exercise Group

EXPERIMENTAL

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.

Behavioral: Exercise Group

Control Group

NO INTERVENTION

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.

Interventions

Exercise Group BEHAVIORAL

Previously described in the arm/group descriptions.

Exercise Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Related Publications (2)

• McIsaac DI, Lee S, Fergusson D, Gillis C, Khadaroo RG, Meliambro A, Muscedere J, Eskander A, Moloo H, Nelson G, Saha T, Chun R, Serrano PE, Wijeysundera DN, Taljaard M; PREPARE Trial Investigator Group; Barnes K, Boet S, Boland L, Branje K, Breau R, Bryson GL, Dhalla I, Dixon E, Dobson G, Farnand M, Forster A, Gagne S, Hladkowicz E, Holroyd-Leduc J, Huang A, Hutton J, Jacobsohn E, Joanisse J, Johnson A, Johnson S, Khalil N, Kidd G, Lalu M, Lavallee LT, Le T, Levine M, Love C, McCartney C, McMullen M, Bergamascki LM, Moore R, Mozel M, Nagpal S, Nantel J, Power B, Scheede-Bergdahl C, Tamblyn-Watts L, Thavorn K, Trottier D, van Walraven C, Yang I. Home-Based Prehabilitation for Older Surgical Patients With Frailty: A Randomized Clinical Trial. JAMA Surg. 2025 Dec 3:e255288. doi: 10.1001/jamasurg.2025.5288. Online ahead of print.

  PMID: 41335421 DERIVED

• 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.

  PMID: 35940835 DERIVED

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel I McIsaac, MD,MPH,FRCPC

  The Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Group allocation will not be indicated in data analyzed by the outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: January 9, 2020
• Study Start: February 24, 2020
• Primary Completion: June 5, 2024
• Study Completion: May 30, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication of one year follow up data.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal. Data can be used to achieve aims in a proposed proposal or for individual participant data meta-analysis. Proposals should be directed to dmcisaac@toh.ca. To gain access, data requestors will need to sign a data access agreement. Data will be shared via an appropriate 3rd party website that is consistent with ethical and health privacy compliant legislation at the time of study conclusion.

Locations

CA (1)