The Prehabilitation Study: Exercise Before Surgery to Improve Patient Function in People

NCT02934230 | Unknown DMC

• 1 other identifier: 20160091
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

The rapid aging of the population means that anesthesiologists care for elderly patients with increasing regularity. Although age is an independent predictor for adverse postoperative outcomes, significant outcome variation exists among older surgical patients. Frailty, a syndrome that describes an aggregate susceptibility to adverse health outcomes due to age-, and disease-related deficits that accumulate across multiple domains is a key predictor of adverse postoperative outcomes in elderly patients. Frail surgical patients are at increased risk of complications, institutionalization, death, and are high healthcare resource users. Multiple stakeholders, including anesthesiologists and patients, have identified improving the outcomes of older patients and preoperative exercise training (prehabilitation) as 2 of the 10 most important areas for future perioperative research. Physical vulnerability is an important aspect of the frailty syndrome, and may be amenable to structured exercise therapy. However, the evidence for preoperative exercise training (prehabilitation) improving postoperative outcomes is obscured by methodological limitations and a focus on non-elderly patients. Recently, evidence has emerged that older and sicker patients may benefit most from prehab, however, this hypothesis has not been formally tested. Because the complex needs of frail perioperative patients require a longitudinal and multidisciplinary approach, the investigators are developing a perioperative surgical home for the frail elderly (PSH-Frail). Development of the PSH-Frail is supported by a robust data collection system, including linkage of prospectively collected data to health administrative data infrastructure to improve efficiency and long-term follow up. The investigators hypothesize that prehabilitation will be a vital intervention supported by the PSH frail, however, high quality evidence from randomized trials is needed to support its efficacy. Therefore, the investigators propose a single center randomized controlled trial of prehabilitation of frail elderly patients having elective abdominal and thoracic cancer surgery to improve postoperative function (primary outcome), and to decrease postoperative resource utilization (secondary outcomes).

Conditions

Cancer; Frailty

Outcome Measures

Primary Outcomes (1)

• Postoperative functional capacity

  Functional capacity at baseline (surgical assessment typically 4 weeks prior to surgery) compared to postoperative functional capacity 30 days after surgery. The primary outcome of this study will be postoperative functional capacity, specifically the 6-minute walk test 30 days after surgery. A clinically relevant difference in this outcome is a change of 25 meters walked over 6 minutes.

  30 days after surgery

Secondary Outcomes (10)

• Functional Mobility

  30 days after surgery

• Patient-reported health outcomes and adverse events: Health Related Quality of Life - health state

  30 and 90 days after surgery

• Patient-reported health outcomes and adverse events: Health Related Quality of Life

  30 and 90 days after surgery

• Patient-reported health outcomes and adverse events: Disability Free Survival

  30 and 90 days after surgery

• Patient-reported health outcomes and adverse events: Adverse Events

  Within 365 days after surgery

Study Arms (2)

Prehabilitation Group

EXPERIMENTAL

The intervention will be a home-based total-body exercise training program (prehabilitation) based on a protocol with proven efficacy in improving the function of non-frail surgical patients in less than 4 weeks of preoperative utilization.Prehabilitation will consist of 3 components: 1) strength training; 2) aerobic exercise and 3) flexibility. Prehabilitation will be prescribed as 1-hour sessions performed a minimum of 3 times per week. Intervention group patients will also be provided with nutritional advice. In addition to paper-based materials outlining the prehabilitation program, weekly prehabilitation teaching sessions will be held at our Cancer Centre for patients randomized to the intervention group, and activity logs and weekly phone calls will be used to measure compliance and to answer questions. During the final week of the program, patients will also participate in a brief qualitative interview over the phone to explore their experience with the program.

Behavioral: Prehabilitation Program

Control Group

NO INTERVENTION

Patients randomized to the control group will be provided standard perioperative care as per our institutional standards. They will receive the World Health Organization (WHO) Global Recommendations for Physical Activity for Health for people 60 years and above pamphlet, as well as Canada's Food Guide. In-hospital perioperative care, and postoperative care, will be at the discretion of each patient's surgeon and anesthesiologist.

Interventions

Prehabilitation Program BEHAVIORAL

Strength training: This component consists of 1 set of 10 repetitions of each exercise: a. push-ups (modified to the individual's level of function as either wall push-ups, knee push-ups, or full push-ups); b. seated row (performed with an elastic resistance band); c. chest fly (performed with an elastic resistance band); d. deltoid lift (performed with an elastic resistance band); e. biceps curls (performed with an elastic resistance band); f. triceps extensions (performed with an elastic resistance band); g. chair squats; h. hamstring curls; i. standing calf raises; j. abdominal crunches (modified to be performed seated in a chair) Aerobics: Walking for 20 minutes at moderate intensity. Flexibility: Chest, arm, leg and truck stretches, with each stretch to be held for 20 seconds, done for 2 repetitions.

Prehabilitation Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• scheduled to undergo elective surgery for intraabdominal or thoracic cancer
• diagnosed with frailty based on the Clinical Frailty Scale (CFS; score of \>4/9 defines frailty)

You may not qualify if:

• cannot communicate in written or oral form in official languages serviced by TOH (English or French)
• unwilling to participate in home-based prehabilitation
• major cardiac risk factors
• scheduled to undergo surgery in fewer than 3 weeks from randomization

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

The Ottawa Hospital, General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Related Publications (3)

• McIsaac DI, Neilipovitz N, Bryson GL, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M, Hladkowicz E. Home-based exercise prehabilitation to improve disease-free survival and return to intended oncologic treatment after cancer surgery in older adults with frailty: a secondary analysis of a randomized trial. Can J Anaesth. 2024 Nov;71(11):1525-1534. doi: 10.1007/s12630-024-02835-w. Epub 2024 Sep 5.

  PMID: 39237725 DERIVED

• McIsaac DI, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, van Walraven C, McCartney CJL, Taljaard M. Home-based prehabilitation with exercise to improve postoperative recovery for older adults with frailty having cancer surgery: the PREHAB randomised clinical trial. Br J Anaesth. 2022 Jul;129(1):41-48. doi: 10.1016/j.bja.2022.04.006. Epub 2022 May 17.

  PMID: 35589429 DERIVED

• McIsaac DI, Saunders C, Hladkowicz E, Bryson GL, Forster AJ, Gagne S, Huang A, Lalu M, Lavallee LT, Moloo H, Nantel J, Power B, Scheede-Bergdahl C, Taljaard M, van Walraven C, McCartney CJL. PREHAB study: a protocol for a prospective randomised clinical trial of exercise therapy for people living with frailty having cancer surgery. BMJ Open. 2018 Jun 22;8(6):e022057. doi: 10.1136/bmjopen-2018-022057.

  PMID: 29934394 DERIVED

MeSH Terms

Conditions

Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel I McIsaac, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: October 14, 2016
• Study Start: January 5, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)