Patients Waiting for Coronary Artery Bypass Graft SurgeryPREHABNCT02219815
Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
A study testing Prehab Intervention in people with Patients Waiting for Coronary Artery Bypass Graft Surgery and Patients Waiting for Aortic Valve Repair or Replacement, run by St. Boniface Hospital at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement, Patients Waiting for Mitral Valve Repair or Replacement
- What is being tested?
- Prehab Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 5 sitesCanada
- Study dates
- Apr 2015to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H3A7
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Laval University
Québec, Quebec, G1V4G5
Saint John Regional Hospital - New Brunswick Heart Centre
Saint John, New Brunswick, E2L4L2
St. Boniface General Hospital
Winnipeg, Manitoba, R2H2A6
About this study
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.
Read the 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.
- Conditions
- Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement, Patients Waiting for Mitral Valve Repair or Replacement, Patients Waiting for Combined Procedures. (CAGB and Valve)
- Being tested
- Prehab Intervention
- Keywords
- Preoperative Care, Exercise Therapy, Cardiac Surgery, Frailty
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehab InterventionBehavioural
Pre-operative, structured exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | 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). |
| Prehab Intervention | Experimental | 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. Receives: Behavioral: Prehab Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post-surgery (approximately 9 weeks after baseline)
Secondary outcomes (26)
Baseline Exercise Capacity
This measure will be assessed using the results of a 6 minute walk test.
Measured: baseline assessment - Study entry
Preoperative Exercise Capacity
This measure will be assessed using the results of a 6 minute walk test.
Measured: Pre-Surgery (approximately 8 weeks after baseline)
3-Month Exercise Capacity
This measure will be assessed using the results of a 6 minute walk test.
Measured: 3 Months Post-Surgery (approximately 5 months after baseline)
1-Year Exercise Capacity
This measure will be assessed using the results of a 6 minute walk test.
Measured: 1 Year Post-Surgery (approximately 14 months after baseline)
Baseline Physical Activity Behaviour
This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Measured: baseline assessment - Study entry
Preoperative Physical Activity Behaviour
This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Measured: Pre-Surgery (approximately 8 weeks after baseline)
3-Month Physical Activity Behaviour
This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Measured: 3 Months Post-Surgery (approximately 5 months after baseline)
1-Year Physical Activity Behaviour
This measure will be assessed objectively using accelerometers. Moderate and vigorous physical activity (MVPA) will be compared
Measured: 1 Year Post-Surgery (approximately 14 months after baseline)
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
Measured: baseline assessment - Study entry
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
Measured: Pre-Surgery (approximately 8 weeks after baseline)
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
Measured: 3 Months Post-Surgery (approximately 5 months after baseline)
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
Measured: 1 Year Post-Surgery (approximately 14 months after baseline)
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
Measured: baseline assessment - Study entry
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
Measured: Pre-Surgery (approximately 8 weeks after baseline)
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
Measured: 3 Months Post-Surgery (approximately 5 months after baseline)
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
Measured: 1 Year Post-Surgery (approximately 14 months after baseline)
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
Measured: Baseline Assessment - Study entry
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
Measured: Pre-Surgery Assessment (approximately 8 weeks after baseline)
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
Measured: 3 Months Post-Surgery (approximately 5 months after baseline)
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
Measured: 1 Year Post-Surgery (approximately 14 months after baseline)
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
Measured: Baseline Assessment - Study entry
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
Measured: Pre-surgery Assessment ( 8 weeks after baseline)
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
Measured: 3 Months Post-Surgery (approximately 5 months after baseline)
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
Measured: 1 year Post-Surgery (approximately 14 months after baseline)
Postoperative Major Adverse Events
Major adverse events include death, myocardial infarction (MI), stroke or renal failure requiring dialysis.
Measured: Post-Surgery (approximately 9 weeks after baseline)
Postoperative Cardiac Rehabilitation Attendance
Will be assessed using administrative data from participating cardiac rehabilitation facilities.
Measured: Post-Surgery (approximately 20 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2014 (estimated)
- Study startApr 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Waiting for Coronary Artery Bypass Graft SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Boniface Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rakesh C. Arora, St. Boniface Hospital
- Investigators
- Rakesh Arora, MD, Principal investigator, St. Boniface Hospital/University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219815
- Sponsor's protocol ID
- PREHAB
- Acronym
- PREHAB
- Status last verified
- Oct 2024
- First submitted
- 30 Jul 2014
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 28801404Stammers 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.
PubMed 25753362
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Rehabilitation for Reduction of Hospitalization After Coronary Bypass and Valvular Surgery.
- ClinicalTrials.gov ID
- NCT02219815
- Acronym / sponsor ID
- PREHAB / PREHAB
- Conditions
- Patients Waiting for Coronary Artery Bypass Graft Surgery, Patients Waiting for Aortic Valve Repair or Replacement, Patients Waiting for Mitral Valve Repair or Replacement, Patients Waiting for Combined Procedures. (CAGB and Valve)
- Keywords
- Preoperative Care, Exercise Therapy, Cardiac Surgery, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- St. Boniface HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Posted 13 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –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). |
| Prehab Intervention | Experimental | Behavioral: Prehab InterventionPatients 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- Patients who have unstable or recent unstable cardiac syndrome as defined by:
- Patients who have severe left ventricular obstructive disease as defined by:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehab InterventionPre-operative, structured exercise intervention. | Behavioural | Prehab Intervention |
Primary outcome
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
26 secondary outcomes
Baseline Exercise Capacity
Time frame: baseline assessment - Study entry
Preoperative Exercise Capacity
Time frame: Pre-Surgery (approximately 8 weeks after baseline)
3-Month Exercise Capacity
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
1-Year Exercise Capacity
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Baseline Physical Activity Behaviour
Time frame: baseline assessment - Study entry
Preoperative Physical Activity Behaviour
Time frame: Pre-Surgery (approximately 8 weeks after baseline)
3-Month Physical Activity Behaviour
Time frame: 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)
Baseline Health-Related Quality of Life
Time frame: baseline assessment - Study entry
Preoperatve Health-Related Quality of Life
Time frame: 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)
1-Year Health-Related Quality of Life
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Baseline Frailty
Time frame: baseline assessment - Study entry
Preoperative Frailty
Time frame: Pre-Surgery (approximately 8 weeks after baseline)
3-Month Frailty
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
1-Year Frailty
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Baseline Anxiety
Time frame: Baseline Assessment - Study entry
Preoperative Anxiety
Time frame: Pre-Surgery Assessment (approximately 8 weeks after baseline)
3-Month Anxiety
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
1-Year Anxiety
Time frame: 1 Year Post-Surgery (approximately 14 months after baseline)
Baseline Depression
Time frame: Baseline Assessment - Study entry
Preoperative Depression
Time frame: Pre-surgery Assessment ( 8 weeks after baseline)
3-Month Depression
Time frame: 3 Months Post-Surgery (approximately 5 months after baseline)
1 Year Depression
Time frame: 1 year Post-Surgery (approximately 14 months after baseline)
Postoperative Major Adverse Events
Time frame: Post-Surgery (approximately 9 weeks after baseline)
Postoperative Cardiac Rehabilitation Attendance
Time frame: Post-Surgery (approximately 20 weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28801404Kehler 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.
- Derived from this study: PubMed 25753362Stammers 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rakesh Arora, MD principal investigator
St. Boniface Hospital/University of Manitoba
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehab Intervention in people with Patients Waiting for Coronary Artery Bypass Graft Surgery and Patients Waiting for Aortic Valve Repair or Replacement, run by St. Boniface Hospital at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Hospital Length of Stay Greater Than 7 Days. (time frame: Post-surgery (approximately 9 weeks after baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02219815, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.