Clinical trial NCT02934230: The Prehabilitation Study: Exercise Before Surgery to Improve Patient Function in People
Official title: The Prehabilitation Study: Exercise Before Surgery to Improve Patient Function in People
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Frailty
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 204
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Detailed description: Frailty is a key risk factor for adverse outcomes among the increasingly large number of older patients presenting for surgery. The complexity and risk profile of frail patients makes them a population who may derive significant benefit from the multidisciplinary and continuous care provided by a Perioperative Surgical Home (PSH) model of care. Development of an evidence-based PSH for the frail elderly (PSH-Frail) is the overarching goal of the investigator's research program. However, the PSH-Frail is a complex intervention, and will require high quality evidence to support inclusion of specific processes and interventions into the overall framework.

To date, the investigator's research group has undertaken prospective studies to support the routine and accurate identification of frail patients before surgery. The next step in the development of the PSH-Frail is testing interventions to improve the outcomes of frail elderly surgical patients. The role of preoperative exercise training (prehabilitation) in improving postoperative outcomes is a priority research area in perioperative medicine, and may provide its most significant impact in frail elderly patients. However, this hypothesis has not been formally tested.

Study design:

A single center, parallel arm randomized controlled trial of home-based prehabilitation vs. standard perioperative care in frail elderly patients undergoing elective surgery for intraabdominal cancer will be conducted. This will be a superiority trial to test the hypothesis that home-based prehabilitation will result in improved postoperative functional outcomes compared to standard care. This protocol is described in keeping with the Standard Protocol Items: Recommendations for Intervention Trials (SPIRIT) guidelines).

Study setting:

This study will be performed at The Ottawa Hospital (TOH), a 900-bed tertiary care academic health sciences center serving a catchment area of 1.2 million people. TOH is the regional cancer referral center for the Eastern portion of the Canadian province of Ontario. On average, cancer patients are seen 4 weeks prior to surgery (as this is a provincial benchmark for cancer care).

Sample size:

To detect a clinically important 25 meter difference in the primary outcome between study arms, using a two-sided test at the 5% level of significance with 80% power, and assuming a standard deviation of 55 meters based on a previously published trial, we will require 77 patients per arm. To account for up to 20% attrition we will enroll 100 patients per arm.

Recruitment:

Patients will be recruited from the investigator's hospital's Cancer Assessment Center. Following cancer diagnosis, patients are seen by a surgeon 4 weeks prior to their scheduled operation. Following surgical assessment and confirmation of the decision to operate, patients who consent to consideration for research contact, and who meet all inclusion criteria except for frailty score, will be assessed by a trained clinician or clinical assistant using the Clinical Frailty Scale (CFS). Patients who score \>4/9 on the CFS will then be randomized after providing written informed consent.

Intervention:

The intervention will be a home-based total-body exercise training program (henceforth referred to as 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.

Control:

Patients randomized to the control group will be provided standard perioperative care as per institutional standards. Patients will receive the World Health Organization (WHO) Global Recommendations for Physical Activity for Health for people 65 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.

Eligibility criteria: Inclusion Criteria:

* 60 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative functional capacity
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Functional Mobility
timeFrame: 30 days after surgery
measure: Patient-reported health outcomes and adverse events: Health Related Quality of Life - health state
timeFrame: 30 and 90 days after surgery
measure: Patient-reported health outcomes and adverse events: Health Related Quality of Life
timeFrame: 30 and 90 days after surgery
measure: Patient-reported health outcomes and adverse events: Disability Free Survival
timeFrame: 30 and 90 days after surgery
measure: Patient-reported health outcomes and adverse events: Adverse Events
timeFrame: Within 365 days after surgery
measure: Patient-reported health outcomes and adverse events: Adverse Events
timeFrame: Within 365 days after surgery
measure: Patient-reported health outcomes and adverse events: Adverse Events
timeFrame: Within 365 days after surgery
measure: Healthcare resource utilization: hospital length of stay
timeFrame: Within 365 days after surgery
measure: Healthcare resource utilization: proportion of patients discharged to an institution, readmissions within 30 days of discharge
timeFrame: Within 365 days after surgery
measure: Healthcare resource utilization: total healthcare costs
timeFrame: Within 365 days after surgery
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital, General Campus
state: Ontario
Study officials:
affiliation: The Ottawa Hospital
name: Daniel I McIsaac, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.