Coronary Artery DiseasePREFECTNCT03399162
PRehabilitiation in Elective Frail and Elderly Cardiac Surgery PaTients
A study testing PREHAB Workshop and PREHAB Exercise Program in people with Coronary Artery Disease and Valvular Heart Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Valvular Heart Disease
- What is being tested?
- PREHAB Workshop and PREHAB Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 20 May 2018to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PRehabilitiation in Elective Frail and Elderly Cardiac Surgery PaTients (PREFECT): Assessing the Impact of a Personalized Prehabilitation Program Before Cardiac Surgery on Frailty and Clinical Outcomes
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.
Read the detailed description
Frailty is a common syndrome among older adults, defined as a "clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function". Fried defined frailty as meeting three out of the five criteria: low grip strength, low energy, slowed walking speed, low physical activity, and/or unintentional weight loss. Clinicians are currently challenged with a rising prevalence of elderly and frail patients presenting for major cardiac surgery. Such patients typically present with a greater comorbidity burden and are more likely to be malnourished, physically deconditioned, and to exhibit decreased physiological adaptation to stress. Frail cardiac surgical patients are, unsurprisingly, at increased risk for major adverse cardiac and cerebrovascular events, short- and longer-term mortality, and increased length of hospital of stay. Clinicians may also struggle to quantify the peri-operative risk of morbidity and mortality among these individuals, since tools such as the Society of Thoracic Surgeons (STS) risk assessment are not designed to comprehensively assess the complex interaction between various risk factors seen in the frail patient.
Cardiovascular rehabilitation (CR) programs are integral to managing patients with cardiovascular disease. Such programs include health behaviour change, and cardiovascular risk factor management (e.g. moderate-to-vigorous-intensity continuous exercise training [MICE], healthy eating, smoking cessation, stress management, and psychological services). The benefits of MICE for patients with cardiovascular disease include improvements in exercise tolerance, muscular strength, cardiovascular health and reduced hospitalizations. MICE is, therefore, able to improve several facets of physical dysfunction, and forms major therapeutic interventions for functional capacity and frailty. Improvements in nutritional status have been observed in patients with cardiovascular disease(CVD) participating in CR, and exercise training and stress management have been shown to reduce distress in CVD patients.
Emerging evidence indicates that CR before cardiac surgery (i.e. prehabilitation [PREHAB]) may improve clinical outcomes. Sawatzky et al. showed that a 12-week PREHAB program consisting of two structured exercise training sessions per week and 12 education sessions concerning cardiovascular risk factor management, exercise, stress, diet, and medication use in patients awaiting coronary artery bypass grafting (CABG) was feasible and significantly improved functional capacity.
Elderly and frail patients are increasingly presenting for cardiac surgery, and these individuals must be carefully optimized pre-operatively to increase the likelihood of their recovery and return to a reasonable quality of life. A personalized PREHAB program that targets and ameliorates the elements of frailty, including low functional capacity, poor nutrition, and stress, offers the best chance of mitigating frailty and its associated risk factors in a way that is feasible, patient-centred, and translatable to other cardiovascular centres. This project will use objective measures, including tests of functional capacity, validated questionnaires, and biomarker analysis, to better quantify the subjective diagnosis of frailty in our patients, and will implement a novel personalized PREHAB program with integrated on-site and home-based exercise sessions, in an attempt to mitigate the frailty and other risk factors that impact patients in the peri-operative period.
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Being tested
- PREHAB Workshop, PREHAB Exercise Program
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREHAB WorkshopBehavioural
PREHAB workshop/education session in the Prevention and Rehabilitation Centre regarding nursing, nutrition, physiotherapy, psychology, and diabetes.
PREHAB Exercise ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: PREHAB Workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
The primary outcome, functional capacity, will be measured using the 6-minute walk test.
Measured: Change between baseline and 8 weeks (+/- 1 week)
Secondary outcomes (8)
Frailty (Fried criteria)
Measured using the Fried frailty score (presence of 3 of the 5 symptoms of frailty)
Measured: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Frailty (clinical score)
Measured using the Clinical Frailty Scale (9 point clinical assessment)
Measured: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Short Form - 36
Measured using the SF-36 Quality of Life questionnaire
Measured: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Depression
Measured using the BDI-II
Measured: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Anxiety
Measured using the BAI
Measured: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Dietary habits
Measured using the Block food frequency questionnaire
Measured: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Exercise adherence
Measured using a pedometer
Measured: Compared between baseline and 8 weeks (+/- 1 week)
Clinical and cardiovascular outcomes
A composite endpoint that will look at the rates of occurrence of major cardiovascular and cerebrovascular outcomes (i.e. death, myocardial infarction, cardiac arrest, stroke) and length of hospitalization.
Measured: In the 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start20 May 2018
- Primary completion1 May 2019
- Study completionAug 2019 (estimated)
Why it stopped: Due to a reduction in surgical wait times, there was insufficient time to complete the intervention prior to surgery.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan B Grau Alvaro, MD, Principal investigator, Ottawa Heart Institute Research CorporationLouise Sun, MD, Principal investigator, Ottawa Heart Institute Research CorporationJennifer Reed, PhD, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399162
- Sponsor's protocol ID
- 20170698
- Acronym
- PREFECT
- Status last verified
- Jun 2019
- First submitted
- 20 Sep 2017
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11253156Afilalo 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.
PubMed 22396586
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRehabilitiation in Elective Frail and Elderly Cardiac Surgery PaTients (PREFECT): Assessing the Impact of a Personalized Prehabilitation Program Before Cardiac Surgery on Frailty and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03399162
- Acronym / sponsor ID
- PREFECT / 20170698
- Conditions
- Coronary Artery Disease, Valvular Heart Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a reduction in surgical wait times, there was insufficient time to complete the intervention prior to surgery.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- Aug 2019 (estimated)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Frailty is a common syndrome among older adults, defined as a "clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function". Fried defined frailty as meeting three out of the five criteria: low grip strength, low energy, slowed walking speed, low physical activity, and/or unintentional weight loss. Clinicians are currently challenged with a rising prevalence of elderly and frail patients presenting for major cardiac surgery. Such patients typically present with a greater comorbidity burden and are more likely to be malnourished, physically deconditioned, and to exhibit decreased physiological adaptation to stress. Frail cardiac surgical patients are, unsurprisingly, at increased risk for major adverse cardiac and cerebrovascular events, short- and longer-term mortality, and increased length of hospital of stay. Clinicians may also struggle to quantify the peri-operative risk of morbidity and mortality among these individuals, since tools such as the Society of Thoracic Surgeons (STS) risk assessment are not designed to comprehensively assess the complex interaction between various risk factors seen in the frail patient.
Cardiovascular rehabilitation (CR) programs are integral to managing patients with cardiovascular disease. Such programs include health behaviour change, and cardiovascular risk factor management (e.g. moderate-to-vigorous-intensity continuous exercise training [MICE], healthy eating, smoking cessation, stress management, and psychological services). The benefits of MICE for patients with cardiovascular disease include improvements in exercise tolerance, muscular strength, cardiovascular health and reduced hospitalizations. MICE is, therefore, able to improve several facets of physical dysfunction, and forms major therapeutic interventions for functional capacity and frailty. Improvements in nutritional status have been observed in patients with cardiovascular disease(CVD) participating in CR, and exercise training and stress management have been shown to reduce distress in CVD patients.
Emerging evidence indicates that CR before cardiac surgery (i.e. prehabilitation [PREHAB]) may improve clinical outcomes. Sawatzky et al. showed that a 12-week PREHAB program consisting of two structured exercise training sessions per week and 12 education sessions concerning cardiovascular risk factor management, exercise, stress, diet, and medication use in patients awaiting coronary artery bypass grafting (CABG) was feasible and significantly improved functional capacity.
Elderly and frail patients are increasingly presenting for cardiac surgery, and these individuals must be carefully optimized pre-operatively to increase the likelihood of their recovery and return to a reasonable quality of life. A personalized PREHAB program that targets and ameliorates the elements of frailty, including low functional capacity, poor nutrition, and stress, offers the best chance of mitigating frailty and its associated risk factors in a way that is feasible, patient-centred, and translatable to other cardiovascular centres. This project will use objective measures, including tests of functional capacity, validated questionnaires, and biomarker analysis, to better quantify the subjective diagnosis of frailty in our patients, and will implement a novel personalized PREHAB program with integrated on-site and home-based exercise sessions, in an attempt to mitigate the frailty and other risk factors that impact patients in the peri-operative period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PREHAB Group | Experimental | Behavioral: PREHAB Workshop, Behavioral: PREHAB Exercise ProgramPatients 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. |
| Standard of care group | Active comparator | Behavioral: PREHAB WorkshopPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 WorkshopPREHAB workshop/education session in the Prevention and Rehabilitation Centre regarding nursing, nutrition, physiotherapy, psychology, and diabetes. | Behavioural | PREHAB Group, Standard of care group |
| PREHAB Exercise ProgramAn 8-week program that consists of: (1) 2x/week 60-minute supervised exercise sessions; and (2) 3x/week 30-minute home-based exercise sessions. | Behavioural | PREHAB Group |
Primary outcome
Functional capacity
Time frame: Change between baseline and 8 weeks (+/- 1 week)
The primary outcome, functional capacity, will be measured using the 6-minute walk test.
8 secondary outcomes
Frailty (Fried criteria)
Time frame: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Frailty (clinical score)
Time frame: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Short Form - 36
Time frame: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Depression
Time frame: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Anxiety
Time frame: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Dietary habits
Time frame: Compared between baseline, 8 weeks (+/- 1 week), and 4 weeks after surgery (+/- 2 weeks)
Exercise adherence
Time frame: Compared between baseline and 8 weeks (+/- 1 week)
Clinical and cardiovascular outcomes
Time frame: In the 6 weeks after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
- Background: PubMed 11253156Fried 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.
- Background: PubMed 22396586Afilalo 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.
- Individual participant dataSharing planned: No
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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.
Juan B Grau Alvaro, MD principal investigator
Ottawa Heart Institute Research Corporation
Louise Sun, MD principal investigator
Ottawa Heart Institute Research Corporation
Jennifer Reed, PhD principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PREHAB Workshop and PREHAB Exercise Program in people with Coronary Artery Disease and Valvular Heart Disease, run by Ottawa Heart Institute Research Corporation at 1 site 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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Functional capacity (time frame: Change between baseline and 8 weeks (+/- 1 week)). 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 NCT03399162, 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 20 Jun 2019.