- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02219815
Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery. (PREHAB)
Study Overview
Status
Conditions
- Patients Waiting for Elective Isolated Coronary Artery Bypass Grafting (CABG)
- Patients Waiting for Aortic Valve Repair/Replacement for Moderate Aortic Stenosis or Severe Regurgitation
- Patients Waiting for Mitral Valve Repair/Replacement for Moderate Stenosis or Severe Regurgitation
- Patients Waiting for Combined Procedures. (CAGB and Valve)
Intervention / Treatment
Detailed Description
PREHAB will be a three centre prospective, randomized, open, blinded endpoint (PROBE) controlled trial using assessor blinding and intention-to-treat analysis. The study will be conducted at three academic, tertiary care hospitals (St. Boniface Hospital, Winnipeg, MB, Montreal Heart Institute. Montreal QC and Queen Elizabeth II Health Sciences Centre, Halifax, NS) and one non-academic hospital (Saint John Regional Health Centre, Saint John, NB) that perform cardiac surgery. These sites were chosen based on similar patient populations and surgical waitlist times. Additionally, each of these sites are partnered with one or more community-based cardiac rehabilitation (CR) centres, which are certified medical fitness facilities dedicated to improving the health of the community through health promotion, disease prevention and rehabilitation services. These facilities offer expert guidance from certified professionals, innovative health enhancement programs, and provide integrated medical, rehabilitative and fitness services. The investigators intend to recruit a total of 244 participants to the study (122 per study arm), anticipating a 20% dropout rate to achieve an eventual sample size of 194 participants.
Patients in the PREHAB group will receive, in addition to standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility. This program will target both the physical and psycho-social-cognitive aspects of cardiac disease and frailty. In brief, participants will be required to complete an intake health status assessment by the CR team including a physiotherapist, cardiovascular nurse, and dietitian and complete a symptom-limited graded exercise stress test according to the American College of Sports Medicine Guidelines for Exercise Testing and Prescription 7th Edition. Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities. This has been shown to be safe and effective in unrepaired heart failure and elderly patients. PREHAB participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R2H2A6
- St. Boniface General Hospital
-
-
New Brunswick
-
Saint John, New Brunswick, Canada, E2L4L2
- Saint John Regional Hospital - New Brunswick Heart Centre
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H3A7
- Queen Elizabeth II Health Sciences Centre
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
-
Quebec City, Quebec, Canada, G1V4G5
- Laval University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 60 years and older, undergoing elective isolated coronary artery bypass grafting (CABG), aortic valve repair/replacement for moderate aortic stenosis or severe regurgitation, mitral valve repair/replacement for moderate stenosis or severe regurgitation or combined CABG/valve procedures
- Patients with Clinical Frailty Score (CFS) ≥3 (vulnerable) and < 7 (8 = very severely frail, approaching end-of-life or 9 = terminally ill) at time of acceptance for cardiac surgery
- Patients with an estimated ≥ 6 week wait time
Exclusion Criteria:
Patients who have unstable or recent unstable cardiac syndrome as defined by:
- Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms
- Critical left main (LM) coronary disease
- Hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome prior to randomization
Patients who have severe left ventricular obstructive disease as defined by:
- Severe aortic or mitral stenosis (aortic or mitral valve area <1.0cm2 or mean gradient > 40 mmHg or > 10 mmHg respectively)
- Dynamic left ventricular (LV) outflow obstruction
- Patients who have demonstrated exercise induced ventricular arrhythmias or have experienced a recent hospitalization for arrhythmias
- Patients who have cognitive deficits that would preclude rehabilitation
- Patients who have physical limitations that would preclude rehabilitation
- Patients who are unable to attend the Prehab program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Standard Care
Patients in the standard care group will receive care as is currently delivered to patients awaiting cardiac surgery at each site.
At present, patients are advised to rest and participate in very light intensity physical activity while awaiting surgery.
At 1-2 weeks prior to their scheduled surgical date, the patient attends a single three hour cardiac pre-assessment with a nurse practitioner and cardiac anesthesiologist.
In addition, a cardiac nurse counsels each patient on healthy behaviors (e.g.
smoking cessation, diet, exercise).
|
|
Experimental: Prehab Intervention
Patients in the Prehab group will receive, in addition to the standard of care, an eight-week comprehensive exercise therapy and education program at a community-based CR facility.
Patients will be asked to complete at least two sessions of supervised, structured exercise class plus have the option to attend one additional exercise class per week for eight-weeks, with progression to a moderate to high-intensity interval program based on the supervised assessment of the patient's capabilities.
Prehab participants will also attend four education sessions on topics such as risk factor reduction, medication use, cardiovascular physiology, smoking cessation, healthy eating, exercise, and stress management and promotion of self-managed care.
|
Pre-operative, structured exercise intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.
Time Frame: Post-surgery (approximately 9 weeks after baseline)
|
Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days
|
Post-surgery (approximately 9 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Exercise Capacity
Time Frame: baseline assessment - Study entry
|
This measure will be assessed using the results of a 6 minute walk test.
|
baseline assessment - Study entry
|
Preoperative Exercise Capacity
Time Frame: Pre-Surgery (approximately 8 weeks after baseline)
|
This measure will be assessed using the results of a 6 minute walk test.
|
Pre-Surgery (approximately 8 weeks after baseline)
|
3-Month Exercise Capacity
Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline)
|
This measure will be assessed using the results of a 6 minute walk test.
|
3 Months Post-Surgery (approximately 5 months after baseline)
|
1-Year Exercise Capacity
Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline)
|
This measure will be assessed using the results of a 6 minute walk test.
|
1 Year Post-Surgery (approximately 14 months after baseline)
|
Baseline Physical Activity Behaviour
Time Frame: baseline assessment - Study entry
|
This measure will be assessed objectively using accelerometers.
Moderate and vigorous physical activity (MVPA) will be compared
|
baseline assessment - Study entry
|
Preoperative Physical Activity Behaviour
Time Frame: Pre-Surgery (approximately 8 weeks after baseline)
|
This measure will be assessed objectively using accelerometers.
Moderate and vigorous physical activity (MVPA) will be compared
|
Pre-Surgery (approximately 8 weeks after baseline)
|
3-Month Physical Activity Behaviour
Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline)
|
This measure will be assessed objectively using accelerometers.
Moderate and vigorous physical activity (MVPA) will be compared
|
3 Months Post-Surgery (approximately 5 months after baseline)
|
1-Year Physical Activity Behaviour
Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline)
|
This measure will be assessed objectively using accelerometers.
Moderate and vigorous physical activity (MVPA) will be compared
|
1 Year Post-Surgery (approximately 14 months after baseline)
|
Baseline Health-Related Quality of Life
Time Frame: baseline assessment - Study entry
|
This measure will be assessed using EuroQual-Visual Analogue Scale.
(EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
|
baseline assessment - Study entry
|
Preoperatve Health-Related Quality of Life
Time Frame: Pre-Surgery (approximately 8 weeks after baseline)
|
This measure will be assessed using EuroQual-Visual Analogue Scale.
(EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
|
Pre-Surgery (approximately 8 weeks after baseline)
|
3-Month Health-Related Quality of Life
Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline)
|
This measure will be assessed using EuroQual-Visual Analogue Scale.
(EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
|
3 Months Post-Surgery (approximately 5 months after baseline)
|
1-Year Health-Related Quality of Life
Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline)
|
This measure will be assessed using EuroQual-Visual Analogue Scale.
(EQ-VAS) This scale ranges from 0 - 100 with 0 = worst health and 100 = best health
|
1 Year Post-Surgery (approximately 14 months after baseline)
|
Baseline Frailty
Time Frame: baseline assessment - Study entry
|
This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
|
baseline assessment - Study entry
|
Preoperative Frailty
Time Frame: Pre-Surgery (approximately 8 weeks after baseline)
|
This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
|
Pre-Surgery (approximately 8 weeks after baseline)
|
3-Month Frailty
Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline)
|
This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
|
3 Months Post-Surgery (approximately 5 months after baseline)
|
1-Year Frailty
Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline)
|
This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
|
1 Year Post-Surgery (approximately 14 months after baseline)
|
Baseline Anxiety
Time Frame: Baseline Assessment - Study entry
|
This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points.
The higher the score the more symptoms of anxiety may be observed
|
Baseline Assessment - Study entry
|
Preoperative Anxiety
Time Frame: Pre-Surgery Assessment (approximately 8 weeks after baseline)
|
This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points.
The higher the score the more symptoms of anxiety may be observed
|
Pre-Surgery Assessment (approximately 8 weeks after baseline)
|
3-Month Anxiety
Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline)
|
This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points.
The higher the score the more symptoms of anxiety may be observed
|
3 Months Post-Surgery (approximately 5 months after baseline)
|
1-Year Anxiety
Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline)
|
This measure will be assessed using the General Anxiety Disorder - 7 (GAD-7) Score is out of 0-21 points.
The higher the score the more symptoms of anxiety may be observed
|
1 Year Post-Surgery (approximately 14 months after baseline)
|
Baseline Depression
Time Frame: Baseline Assessment - Study entry
|
This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5.
A score of 2 or more may indicated symptoms of depression
|
Baseline Assessment - Study entry
|
Preoperative Depression
Time Frame: Pre-surgery Assessment ( 8 weeks after baseline)
|
This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5.
A score of 2 or more may indicated symptoms of depression
|
Pre-surgery Assessment ( 8 weeks after baseline)
|
3-Month Depression
Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline)
|
This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5.
A score of 2 or more may indicated symptoms of depression
|
3 Months Post-Surgery (approximately 5 months after baseline)
|
1 Year Depression
Time Frame: 1 year Post-Surgery (approximately 14 months after baseline)
|
This measure will be assessed using the Five-item Geriatric Depression Scale (GDS-5) Score is based from 0-5.
A score of 2 or more may indicated symptoms of depression
|
1 year Post-Surgery (approximately 14 months after baseline)
|
Postoperative Major Adverse Events
Time Frame: Post-Surgery (approximately 9 weeks after baseline)
|
Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.
|
Post-Surgery (approximately 9 weeks after baseline)
|
Postoperative Cardiac Rehabilitation Attendance
Time Frame: Post-Surgery (approximately 20 weeks after baseline)
|
Will be assessed using administrative data from participating cardiac rehabilitation facilities.
|
Post-Surgery (approximately 20 weeks after baseline)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rakesh Arora, MD, St. Boniface Hospital/University of Manitoba
Publications and helpful links
General Publications
- Kehler DS, Stammers AN, Tangri N, Hiebert B, Fransoo R, Schultz ASH, Macdonald K, Giacomontonio N, Hassan A, Legare JF, Arora RC, Duhamel TA. Systematic review of preoperative physical activity and its impact on postcardiac surgical outcomes. BMJ Open. 2017 Aug 11;7(8):e015712. doi: 10.1136/bmjopen-2016-015712.
- Stammers AN, Kehler DS, Afilalo J, Avery LJ, Bagshaw SM, Grocott HP, Legare JF, Logsetty S, Metge C, Nguyen T, Rockwood K, Sareen J, Sawatzky JA, Tangri N, Giacomantonio N, Hassan A, Duhamel TA, Arora RC. Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction of Hospitalization After coronary Bypass and valvular surgery: a randomised controlled trial. BMJ Open. 2015 Mar 9;5(3):e007250. doi: 10.1136/bmjopen-2014-007250.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prehab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Patients Waiting for Elective Isolated Coronary Artery Bypass Grafting (CABG)
-
St. Boniface HospitalCompletedPatients Waiting for Elective Coronary Artery Bypass Graft SurgeryCanada
-
Qazvin University Of Medical SciencesCompletedCoronary Artery Bypass Grafting (CABG) SurgeryIran, Islamic Republic of
-
University Hospital, GhentCAS Medical Systems, Inc.; Belgian Foundation for Cardiac SurgeryCompletedElective Off-pump Coronary Artery Bypass GraftingBelgium
-
Meshalkin Research Institute of Pathology of CirculationCompletedAutovenous Conduit for Coronary Artery Bypass Grafting
-
Eastern Mediterranean UniversityCompletedDischarge Training and Telephone Counseling for Coronary Artery Bypass Graft PatientsCyprus
-
Temple UniversityTerminatedPatients Undergoing Elective Coronary Artery Bypass GraftUnited States
-
China National Center for Cardiovascular DiseasesMinistry of Science and Technology of the People´s Republic of ChinaUnknownCoronary Artery Bypass Grafting | Surgical Treatment for Heart Valve DiseasesChina
-
University Hospital, AntwerpUniversitaire Ziekenhuizen KU Leuven; KU LeuvenUnknownPercutaneous Coronary Intervention (PCI) | Coronary Artery Disease (CAD); | Myocardial Infarction (MI) | Coronary Artery Bypass Grafting (CABG)Belgium
-
St. Petersburg State Pavlov Medical UniversityCompletedAutologous Bone Marrow Mononuclear Cells in the Combined Treatment of Coronary Heart Disease (TAMIS)Ischemic Heart Disease | Heart Failure, Diastolic | Coronary Artery Bypass Grafting (CABG) | Bone Marrow CellsRussian Federation
-
Philipps University Marburg Medical CenterCompletedCoronary Heart Disease | Patients' Expectations | Coronary Artery Bypass Graft Surgery (CABG)Germany
Clinical Trials on Prehab Intervention
-
Balgrist University HospitalMaastricht UniversityCompletedOsteoarthritis, KneeSwitzerland
-
Ottawa Heart Institute Research CorporationWithdrawnCoronary Artery Disease | Valvular Heart DiseaseCanada
-
Jason MartynAlberta Health services; University of Alberta; University of Calgary; Physiotherapy...UnknownBladder Cancer | Nutrition Aspect of Cancer
-
University of Guelph-HumberUniversity Health Network, Toronto; McGill University Health Centre/Research... and other collaboratorsCompletedProstate Cancer Patients Undergoing Radical ProstatectomyCanada
-
Cedars-Sinai Medical CenterRecruitingPancreas CancerUnited States
-
University of NebraskaCompletedExercise Training | Heart Failure NYHA Class IV | Heart-Assist DevicesUnited States
-
St. Boniface HospitalCompletedPatients Waiting for Elective Coronary Artery Bypass Graft SurgeryCanada
-
Wake Forest University Health SciencesCompleted
-
McMaster UniversityUniversity of Alberta; University of CalgaryRecruiting
-
Nantes University HospitalNot yet recruitingAnterior-cruciate Ligament Knee Injury