MedTrace Logo

PRehabilitiation in Elective Frail and Elderly Cardiac Surgery PaTients

NCT03399162 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-06-20

No results posted yet for this study

Summary

Older and more frail adults are more often being referred for cardiac surgery. These patients are often in suboptimal health, and may be physically frail, malnourished, and have other conditions, such as diabetes, that complicate their recovery. Research suggests that a rehabilitation program prior to surgery may help improve participants' health and improve their fitness for surgery. Currently, a pre-operative rehabilitation workshop is offered at the University of Ottawa Heart Institute, but this interventional, randomized study will investigate whether a more comprehensive pre-operative regime, including structured weekly exercise program, is more effective at improving health prior to surgery. Patients will be randomized to either the control group (pre-operative rehabilitation workshop ONLY) or the treatment group (pre-operative rehabilitation workshop plus exercise regime). This regime will attempt to improve patients' overall health, including their physical fitness and nutritional status. The effectiveness of this regime will be evaluated by comparing patients' physical function, questionnaires (diet, quality of life, stress) and serum biomarkers from baseline to pre-surgery to post-surgery. The Investigators hypothesize that patients that complete the pre-operative rehabilitation program will improve their health prior to surgery, and that this may result in shorter length of hospitalization and fewer complications after surgery. The study will take place over two years, with each patient's participation lasting about 3 months.

Conditions

Interventions

BEHAVIORAL

PREHAB Workshop

PREHAB workshop/education session in the Prevention and Rehabilitation Centre regarding nursing, nutrition, physiotherapy, psychology, and diabetes.

BEHAVIORAL

PREHAB Exercise Program

An 8-week program that consists of: (1) 2x/week 60-minute supervised exercise sessions; and (2) 3x/week 30-minute home-based exercise sessions.

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Juan B Grau Alvaro, MD · Ottawa Heart Institute Research Corporation

  • Louise Sun, MD · Ottawa Heart Institute Research Corporation

  • Jennifer Reed, PhD · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-20
Primary Completion
2019-05-01
Completion
2019-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT03399162 on ClinicalTrials.gov