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Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery. (PREHAB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219815
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Rakesh C. Arora, St. Boniface Hospital

Brief Summary:
The PREHAB study is a clinical trial where frail patients waiting for heart surgery are randomly chosen to either receive the current standard of care or to participate in an 8-week exercise/education program at a community-based cardiac rehabilitation facility. Patients can wait for elective heart surgery for as long as 3-4 months. During this time, individuals are often fearful of making things worse, causing them to stop being active and further deteriorate their physical condition. This wait period presents a potential opportunity for health care providers to engage the patient to take control of their self-managed care prior to surgery with the intent of improving post-surgical outcomes. Patients randomized to the PREHAB intervention group will participate in supervised exercise twice per week in a program designed to improve physical functioning and exercise capacity. The investigators hypothesize that the PREHAB program for frail elderly patients awaiting an elective cardiac surgery will reduce frailty, improve exercise capacity, improve physical activity behaviour, improve in-hospital outcomes, improve clinical outcomes 3 months and 1 year postoperatively, and improve overall quality of life.

Condition or disease Intervention/treatment Phase
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) Behavioral: Prehab Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
Study Start Date : April 2015
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018


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.
Behavioral: Prehab Intervention
Pre-operative, structured exercise intervention.




Primary Outcome Measures :
  1. Proportion of patients with hospital length of stay greater than 7 days. [ Time Frame: Post-surgery (approximately 9 weeks after baseline) ]

Secondary Outcome Measures :
  1. Preoperative Frailty [ Time Frame: Pre-Surgery (approximately 8 weeks after baseline) ]
    This measure will be assessed using the Modified Fried Criteria, Clinical Frailty Scale and the Short Performance Physical Battery Test.

  2. Preoperative Exercise Capacity [ Time Frame: Pre-Surgery (approximately 8 weeks after baseline) ]
    This measure will be assessed using the results of an exercise stress test and a 6 minute walk test.

  3. 3-Month Exercise Capacity [ Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline) ]
    This measure will be assessed using the results of an exercise stress test and a 6 minute walk test.

  4. 1-Year Exercise Capacity [ Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline) ]
    This measure will be assessed using the results of an exercise stress test and a 6 minute walk test.

  5. Preoperative Physical Activity Behaviour [ Time Frame: Pre-Surgery (approximately 8 weeks after baseline) ]
    This measure will be assessed objectively using accelerometers in addition to self-report questionnaires including the Paffenbarger Physical Activity Index, Physical Activity of the Elderly Scale, International Physical Activity Questionnaire and the Fowles Third Survey of Physical Activity.

  6. 3-Month Physical Activity Behaviour [ Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline) ]
    This measure will be assessed objectively using accelerometers in addition to self-report questionnaires including the Paffenbarger Physical Activity Index, Physical Activity of the Elderly Scale, International Physical Activity Questionnaire and the Fowles Third Survey of Physical Activity.

  7. Postoperative Intensive Care Unit and Hospital Length of Stay [ Time Frame: Post-Surgery (approximately 9 weeks after baseline) ]
    Postoperative Intensive Care Unite and hospital length of stay

  8. 3-Month Health-Related Quality of Life [ Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline) ]
    This measure will be assessed using the Short Form-12 (SF-12v2), EuroQual-5D (EQ-5D), and EuroQual-Visual Analogue Scale.

  9. 1-Year Health-Related Quality of Life [ Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline) ]
    This measure will be assessed using the Short Form-12 (SF-12v2), EuroQual-5D (EQ-5D), and EuroQual-Visual Analogue Scale.

  10. 1-Year Physical Activity Behaviour [ Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline) ]
    This measure will be assessed objectively using accelerometers in addition to self-report questionnaires including the Paffenbarger Physical Activity Index, Physical Activity of the Elderly Scale, International Physical Activity Questionnaire and the Fowles Third Survey of Physical Activity.

  11. Postoperative 30-Day Mortality [ Time Frame: Post-Surgery (approximately 9 weeks after baseline) ]
    30-Day Mortality

  12. 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.

  13. Postoperative Cardiac Rehabilitation Attendance [ Time Frame: Post-Surgery (approximately 12 weeks after baseline) ]
    Will be assessed using administrative data from participating cardiac rehabilitation facilities.

  14. 3-Month Frailty [ Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline) ]
    This measure will be assessed using the Modified Fried Criteria, Clinical Frailty Scale and the Short Performance Physical Battery Test.

  15. 1-Year Frailty [ Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline) ]
    This measure will be assessed using the Modified Fried Criteria, Clinical Frailty Scale and the Short Performance Physical Battery Test.

  16. Preoperative Anxiety and Depression [ Time Frame: Pre-Surgery (approximately 8 weeks after baseline) ]
    This measure will be assessed using the Geriatric Depression Scale, Patient Health Questionnaire, and the Montreal Cognitive Assessment.

  17. 3-Month Anxiety and Depression [ Time Frame: 3 Months Post-Surgery (approximately 5 months after baseline) ]
    This measure will be assessed using the Geriatric Depression Scale, Patient Health Questionnaire, and the Montreal Cognitive Assessment.

  18. 1-Year Anxiety and Depression [ Time Frame: 1 Year Post-Surgery (approximately 14 months after baseline) ]
    This measure will be assessed using the Geriatric Depression Scale, Patient Health Questionnaire, and the Montreal Cognitive Assessment.

  19. Preoperative Health Related Quality of Life [ Time Frame: Pre-Surgery (approximately 8 weeks after baseline) ]
    This measure will be assessed using the Short Form-12 (SF-12v2), EuroQual-5D (EQ-5D), and EuroQual-Visual Analogue Scale.

  20. Baseline Frailty [ Time Frame: Baseline (upon entry into study) ]
    This measure will be assessed using the Modified Fried Criteria, Clinical Frailty Scale and the Short Performance Physical Battery Test.

  21. Baseline Physical Activity Behaviour [ Time Frame: Baseline (upon entry into study) ]
    This measure will be assessed objectively using accelerometers in addition to self-report questionnaires including the Paffenbarger Physical Activity Index, Physical Activity of the Elderly Scale, International Physical Activity Questionnaire and the Fowles Third Survey of Physical Activity.

  22. Baseline Anxiety and Depression [ Time Frame: Baseline (upon entry into study) ]
    This measure will be assessed using the Geriatric Depression Scale, Patient Health Questionnaire, and the Montreal Cognitive Assessment.

  23. Baseline Exercise Capacity [ Time Frame: Baseline (upon entry into study) ]
    This measure will be assessed using the results of an exercise stress test and a 6 minute walk test.

  24. Baseline Health-Related Quality of Life [ Time Frame: Baseline (upon entry into study) ]
    This measure will be assessed using the Short Form-12 (SF-12v2), EuroQual-5D (EQ-5D), and EuroQual-Visual Analogue Scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

    1. Severe heart failure (NYHA IV) or angina (CCS class IV) symptoms
    2. Critical left main (LM) coronary disease
    3. Hospitalization for arrhythmias, congestive heart failure or acute coronary syndrome prior to randomization
  • Patients who have severe left ventricular obstructive disease as defined by:

    1. Severe aortic or mitral stenosis (aortic or mitral valve area <1.0cm2 or mean gradient > 40 mmHg or > 10 mmHg respectively)
    2. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219815


Locations
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Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H2A6
Canada, New Brunswick
Saint John Regional Hospital - New Brunswick Heart Centre
Saint John, New Brunswick, Canada, E2L4L2
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H3A7
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Laval University
Quebec City, Quebec, Canada, G1V4G5
Sponsors and Collaborators
St. Boniface Hospital
Investigators
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Principal Investigator: Rakesh Arora, MD St. Boniface Hospital/University of Manitoba
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Rakesh C. Arora, Medical Director, Intensive Care Cardiac Sciences, St. Boniface Hospital
ClinicalTrials.gov Identifier: NCT02219815    
Other Study ID Numbers: PREHAB
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dr. Rakesh C. Arora, St. Boniface Hospital:
Preoperative Care
Exercise Therapy
Cardiac Surgery
Frailty
Additional relevant MeSH terms:
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Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction