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

NCT02934230 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2020-06-09

No results posted yet for this study

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

Interventions

BEHAVIORAL

Prehabilitation Program

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.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Daniel I McIsaac, MD · The Ottawa Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-05
Primary Completion
2020-03-31
Completion
2021-03-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02934230 on ClinicalTrials.gov