PRehabilitiation in Elective Frail and Elderly Cardiac Surgery PaTients

NCT03399162 | Withdrawn DMC

• 1 other identifier: 20170698
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Coronary Artery Disease; Valvular Heart Disease

Outcome Measures

Primary Outcomes (1)

• Functional capacity

  The primary outcome, functional capacity, will be measured using the 6-minute walk test.

  Change between baseline and 8 weeks (+/- 1 week)

Secondary Outcomes (8)

• Frailty (Fried criteria)

  Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)

• Frailty (clinical score)

  Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)

• Short Form - 36

  Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)

• Depression

  Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)

• Anxiety

  Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)

Other Outcomes (1)

• Biomarkers

  Compared between baseline and 8 weeks (+/- 1 week)

Study Arms (2)

PREHAB Group

EXPERIMENTAL

Patients in this arm will receive the usual standard of care prior to surgery, which includes a PREHAB workshop; consultations with a surgeon, anaesthesiologist, and nurse; referrals to diabetes counselling and/or smoking cessation, as appropriate; and the usual diagnostic work-up. Patients in this group will also complete an 8-week PREHAB exercise program, with weekly exercise classes and a list of exercises to complete at home.

Behavioral: PREHAB Workshop; Behavioral: PREHAB Exercise Program

Standard of care group

ACTIVE COMPARATOR

Patients in this arm will receive the usual standard of care prior to surgery, which includes a PREHAB workshop; consultations with a surgeon, anaesthesiologist, and nurse; referrals to diabetes counselling and/or smoking cessation, as appropriate; and the usual diagnostic work-up.

Behavioral: PREHAB Workshop

Interventions

PREHAB Workshop BEHAVIORAL

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

PREHAB Group; Standard of care group

PREHAB Exercise Program BEHAVIORAL

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.

PREHAB Group

Eligibility Criteria

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

You may qualify if:

• Patients \>18 years of age
• Patients able to provide informed consent
• Patients undergoing elective cardiac surgery for either CABG, valve, or CABG + valve
• Patients who have an estimated wait time of at least 10 weeks.
• Patients who are either ≥65 years of age or classified as frail using Fried Frailty criteria or scoring at least 3 on the Clinical Frailty Scale

You may not qualify if:

• Patients with current or recent unstable cardiac disease, defined as and of the following:
• CCS class IV angina,
• NYHA Class III or IV heart failure,
• Critical left main disease,
• hospitalization for arrhythmia within the last month
• Dynamic ventricular outflow obstruction
• Symptomatic exercise-induced arrhythmia
• Patients who are cognitively, geographically or physically unable to complete the PREHAB sessions
• Patients who, in the opinion of either their treating physician or the study investigators, should not participate in a pre-operative rehabilitation program.

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y4W7, Canada

Location

Related Publications (2)

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Afilalo J, Mottillo S, Eisenberg MJ, Alexander KP, Noiseux N, Perrault LP, Morin JF, Langlois Y, Ohayon SM, Monette J, Boivin JF, Shahian DM, Bergman H. Addition of frailty and disability to cardiac surgery risk scores identifies elderly patients at high risk of mortality or major morbidity. Circ Cardiovasc Qual Outcomes. 2012 Mar 1;5(2):222-8. doi: 10.1161/CIRCOUTCOMES.111.963157. Epub 2012 Mar 6.

  PMID: 22396586 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Juan B Grau Alvaro, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Louise Sun, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Jennifer Reed, PhD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: January 16, 2018
• Study Start: May 20, 2018
• Primary Completion: May 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 20, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)