Patients Waiting for Aortic Valve Repair or Replacement, Patients Waiting for Combined Procedures. (CAGB and Valve), Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Mitral Valve Repair or Replacement
Conditions
Keywords
Preoperative Care, Exercise Therapy, Cardiac Surgery, Frailty
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.
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.
Interventions
BEHAVIORALPrehab Intervention
Pre-operative, structured exercise intervention.
Sponsors
St. Boniface Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Exercise Capacity | Pre-Surgery (approximately 8 weeks after baseline) | This measure will be assessed using the results of a 6 minute walk test. |
| 3-Month Exercise Capacity | 3 Months Post-Surgery (approximately 5 months after baseline) | This measure will be assessed using the results of a 6 minute walk test. |
| 1-Year Exercise Capacity | 1 Year Post-Surgery (approximately 14 months after baseline) | This measure will be assessed using the results of a 6 minute walk test. |
| Baseline Physical Activity Behaviour | baseline assessment - Study entry | This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared |
| Preoperative Physical Activity Behaviour | Pre-Surgery (approximately 8 weeks after baseline) | This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared |
| 3-Month Physical Activity Behaviour | 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 |
| 1-Year Physical Activity Behaviour | 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 |
| Baseline Health-Related Quality of Life | 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 |
| Preoperatve Health-Related Quality of Life | 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 |
| 3-Month Health-Related Quality of Life | 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 |
| 1-Year Health-Related Quality of Life | 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 |
| Baseline Frailty | 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 Exercise Capacity | baseline assessment - Study entry | This measure will be assessed using the results of a 6 minute walk test. |
| 3-Month Frailty | 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 |
| 1-Year Frailty | 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 |
| Baseline Anxiety | 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 |
| Preoperative Anxiety | 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 |
| 3-Month Anxiety | 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 |
| 1-Year Anxiety | 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 |
| Baseline Depression | 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 |
| Preoperative Depression | 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 |
| 3-Month Depression | 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 |
| 1 Year Depression | 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 |
| Postoperative Major Adverse Events | Post-Surgery (approximately 9 weeks after baseline) | Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis. |
| Postoperative Cardiac Rehabilitation Attendance | Post-Surgery (approximately 20 weeks after baseline) | Will be assessed using administrative data from participating cardiac rehabilitation facilities. |
| Preoperative Frailty | 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 42 |
| 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.
Prehab Intervention: Pre-operative, structured exercise intervention. | 39 |
| Total | 81 |
Baseline characteristics
| Characteristic | Prehab Intervention | Total | Standard Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 35 Participants | 66 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 15 Participants | 11 Participants |
| Age, Continuous | 71.4 years STANDARD_DEVIATION 6.4 | 70.3 years STANDARD_DEVIATION 5.9 | 69.3 years STANDARD_DEVIATION 5.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 39 participants | 81 participants | 42 participants |
| Sex: Female, Male Female | 5 Participants | 16 Participants | 11 Participants |
| Sex: Female, Male Male | 34 Participants | 65 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 39 |
| other Total, other adverse events | 8 / 42 | 3 / 39 |
| serious Total, serious adverse events | 2 / 42 | 1 / 39 |
Outcome results
Primary
Proportion of Patients With Hospital Length of Stay Greater Than 7 Days.
Proportion of patients with hospital length of stay greater than 7 days compared to those with less than 7 days
Time frame: Post-surgery (approximately 9 weeks after baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. | 20 Participants |
| Prehab Intervention | Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. | 16 Participants |
Secondary
1-Year Anxiety
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
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Secondary
1 Year Depression
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
Time frame: 1 year Post-Surgery (approximately 14 months after baseline)
Secondary
1-Year Exercise Capacity
This measure will be assessed using the results of a 6 minute walk test.
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Secondary
1-Year Frailty
This measure will be assessed using the Modified Fried Criteria Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Secondary
1-Year Health-Related Quality of Life
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
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Secondary
1-Year Physical Activity Behaviour
This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Secondary
3-Month Anxiety
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
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
Secondary
3-Month Depression
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
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
Secondary
3-Month Exercise Capacity
This measure will be assessed using the results of a 6 minute walk test.
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
Secondary
3-Month Frailty
This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
Secondary
3-Month Health-Related Quality of Life
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
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
Secondary
3-Month Physical Activity Behaviour
This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
Secondary
Baseline Anxiety
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
Time frame: Baseline Assessment - Study entry
Secondary
Baseline Depression
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
Time frame: Baseline Assessment - Study entry
Secondary
Baseline Exercise Capacity
This measure will be assessed using the results of a 6 minute walk test.
Time frame: baseline assessment - Study entry
Secondary
Baseline Frailty
This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Time frame: baseline assessment - Study entry
Secondary
Baseline Health-Related Quality of Life
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
Time frame: baseline assessment - Study entry
Secondary
Baseline Physical Activity Behaviour
This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Time frame: baseline assessment - Study entry
Secondary
Postoperative Cardiac Rehabilitation Attendance
Will be assessed using administrative data from participating cardiac rehabilitation facilities.
Time frame: Post-Surgery (approximately 20 weeks after baseline)
Secondary
Postoperative Major Adverse Events
Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.
Time frame: Post-Surgery (approximately 9 weeks after baseline)
Secondary
Preoperative Anxiety
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
Time frame: Pre-Surgery Assessment (approximately 8 weeks after baseline)
Secondary
Preoperative Depression
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
Time frame: Pre-surgery Assessment ( 8 weeks after baseline)
Secondary
Preoperative Exercise Capacity
This measure will be assessed using the results of a 6 minute walk test.
Time frame: Pre-Surgery (approximately 8 weeks after baseline)
Secondary
Preoperative Frailty
This measure will be assessed using the Modified Fried Criteria score Score ranges from 0 - 5, 0=not frail, 1=prefrail, 2-5=frail
Time frame: Pre-Surgery (approximately 8 weeks after baseline)
Secondary
Preoperative Physical Activity Behaviour
This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Time frame: Pre-Surgery (approximately 8 weeks after baseline)
Secondary
Preoperatve Health-Related Quality of Life
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
Time frame: Pre-Surgery (approximately 8 weeks after baseline)