Coronary (Artery); DiseaseHeart-ROCQNCT02984449
Preventive Heart Rehabilitation to Prevent Complications in Patients Undergoing Elective Open Heart Surgery
A study testing Pre+post-operative Cardiac rehabilitation and Postoperative Cardiac rehabilitation in people with Coronary (Artery); Disease and Aortic Valve Stenosis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Rationale: Patients undergoing cardiac surgery are at risk of developing perioperative complications and major adverse cardiac events, mainly related to both their preoperative status and type of surgical procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary (Artery); Disease, Aortic Valve Stenosis, Cardiac Surgery
- What is being tested?
- Pre+post-operative Cardiac rehabilitation and Postoperative Cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteNetherlands
- Study dates
- 3 May 2017to 31 Aug 2025
- 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 admitted to the department of Thoracic Surgery of the UMCG for:
- coronary artery bypass graft surgery
- valve surgery
- aortic surgery
- or a combination of the surgeries mentioned above
Who cannot join
- Patients accepted for transcatheter aortic valve implantation (TAVI)
- Patients undergoing congenital heart surgery
- Aortic descendens or dissections surgery
- Elite athletes
- Co-morbidities that prevent participation in one or more program elements (e.g. disorders to the nervous or musculoskeletal system that limits exercise capacity, severe COPD (GOLD class 3-4), addiction to alcohol or drugs/ serious psychiatric illness) or when it is undesirable to exercise (e.g. cardiomyopathy/morrow).
- Other treatment planned that possibly will interrupt the program (for example on a waiting list for an organ transplantation, preoperative endocarditis or planned chemotherapy for cancer etc.)
- Unable to read, write and understand Dutch
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
J. Hartog, MSc, 0031503617527, j.hartog@umcg.nl
M.A. Mariani, PhD, MSc, 0031503613238, m.mariani@umcg.nl
About this study
Official title: Preventive Heart Rehabilitation in Patients Undergoing Elective Open Heart Surgery to Prevent Complications and to Improve Quality of Life (Heart-ROCQ) - A Prospective Randomized Open Controlled Trial, Blinded End-point (PROBE)
Rationale:
Patients undergoing cardiac surgery are at risk of developing perioperative complications and major adverse cardiac events, mainly related to both their preoperative status and type of surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an effective therapy to prolong survival and improve quality of life. However, little is known about the effect on post-operative complications, quality of life and return to work of a combined pre- and post-operative CR program encompassing physical therapy, dietary counseling, psychological support and life style management compared to a CR program, which is provided only after cardiac surgery.
Read more
Objective:
to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up to three months) and long term outcomes (up to one year) of the cardiac surgery (i.e. reduction in postoperative surgical complications, readmissions to hospital and major adverse cardiac events in conjunction with improvements in the physical component of health related quality of life), when compared to postoperative CR only (POST).
Study design:
A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized between two standard care CR programs. One group will start a the POST CR program after surgery. The other group will be randomized to a combined PRE+POST CR program.
Study population:
Patients (age > 18 years) admitted for elective coronary bypass surgery, valve surgery and/or aortic surgery
Main study parameters/endpoints:
The primary outcome is a composite weighted endpoint of postoperative surgical complications, re-admissions to hospital, major adverse cardiac events and health related quality of life (two domains: physical functioning and physical problem), at three months and one year after surgery. Endpoints are determined by an independent endpoint committee, blinded to the group allocation. Secondary, the study focuses on physical health (cardiorespiratory fitness, muscle strength and functional status), psychological health (feelings of anxiety and depression), work participation, economics, lifestyle risk factors (physical activity and smoking behavior), self-efficacy and illness representations.
- Being tested
- Pre+post-operative Cardiac rehabilitation, Postoperative Cardiac rehabilitation
- Keywords
- cardiac rehabilitation, surgical complications, quality of life, preoperative, cardiac surgery
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre+post-operative Cardiac rehabilitationBehavioural
Also called Exercise, physical fitness, nutrition, psychological support
CR has the aim to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions (BACPR, 2012).
Postoperative Cardiac rehabilitationBehavioural
Also called Exercise, physical fitness, nutrition, psychological support
CR has the aim to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions (BACPR, 2012).
| Study group | Role | What they receive |
|---|---|---|
| Pre+postoperative Cardiac rehabilitation | Experimental | receive a cardiac rehabilitation program consisting of three phases. 1) A preoperative optimization phase (3x p/wk, 4-6 weeks, before surgery), 2) a postoperative in-patient phase (15 to 18 days in rehabilitation center, weekend at home) and, 3) an outpatient patient clinical rehabilitation phase (2x p/wk, 4 weeks). During each phase, patients will visit a physical therapist (group sessions of inspiratory muscle training (IMT), strength training, aerobic cycling and breath, cough and relaxation sessions), a dietician and a psychologist to optimize general health and receive advice on lifestyle, anxiety and stress management. Two additional components are coaching to stop smoking Receives: Behavioral: Pre+post-operative Cardiac rehabilitation |
| Postoperative Cardiac rehabilitation | Active comparator | Patients who are randomized to the POST group receive an out-patient cardiac rehabilitation program after surgery. In general, this program starts three to six weeks after discharge (phase ǀǀ) and patients always start with an exercise program, which is supervised by a physical therapist for about six weeks (twice a week). On indication support of psychological and/or dietary consult is added. Receives: Behavioral: Postoperative Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events
Each event, complication or worsening in functional status are considered as a score of 1 to 3 points. These points are summed to calculate the total score.
Measured: Up to one year post-surgery
Secondary outcomes (15)
Atrial fibrillation
Measured: up to one year post-surgery
prolonged stay at the intensive care unit
Measured: up to one year post-surgery
re-thoracotomy
Measured: up to one year post-surgery
re-admissions to intensive care unit
Measured: up to one year post-surgery
re-admissions to hospital
Measured: up to one year post-surgery
All-cause mortality
Measured: up to five year post-surgery
six minutes walking test
Measured: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
muscle strength
This will include grip strength and knee extension
Measured: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
functional status (KATZ)
Measured: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Quality of life (Rand-36-v2)
Measured: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Depression (PHQ-9)
Measured: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Anxiety (GAD)
Depression (PHQ-9), anxiety (GAD), Quality of life (Rand-36-v2)
Measured: Baseline, one day before surgery, 4-7 days, 3-4 months and one year after surgery
iMTA Productivity Cost Questionnaire (PCQ)
Measured: Baseline, 3-4, 7-8 and 12 months post-surgery
iMTA Medical Cost Questionnaire (MCQ)
Measured: Baseline, 3-4, 7-8 and 12 months post-surgery
Lifestyle risk factors
Physical activity is assessed using the Sensewear GECKO mini-armband (SWA) and the long version (27 questions) of the International Physical Activity Questionnaire (iPAQ)
Measured: Baseline, 3-4 months and one year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study start3 May 2017
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 University Medical Center GroningenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.A. Mariani, University Medical Center Groningen
- Investigators
- MA Mariani, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984449
- Sponsor's protocol ID
- METc: 2016/464 UMCG: 201600576
- Acronym
- Heart-ROCQ
- Status last verified
- Apr 2019
- First submitted
- 29 Nov 2016
- Last updated
- 30 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hartog J, Blokzijl F, Dijkstra S, DeJongste MJL, Reneman MF, Dieperink W, van der Horst ICC, Fleer J, van der Woude LHV, van der Harst P, Mariani MA. Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life (Heart-ROCQ): study protocol for a prospective, randomised, open, blinded endpoint (PROBE) trial. BMJ Open. 2019 Sep 18;9(9):e031738. doi: 10.1136/bmjopen-2019-031738.
PubMed 31537574
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Heart Rehabilitation in Patients Undergoing Elective Open Heart Surgery to Prevent Complications and to Improve Quality of Life (Heart-ROCQ) - A Prospective Randomized Open Controlled Trial, Blinded End-point (PROBE)
- ClinicalTrials.gov ID
- NCT02984449
- Acronym / sponsor ID
- Heart-ROCQ / METc: 2016/464 UMCG: 201600576
- Keywords
- cardiac rehabilitation, surgical complications, quality of life, preoperative, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 3 May 2017 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 7 Dec 2016 (estimated)
- 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.
Rationale:
Patients undergoing cardiac surgery are at risk of developing perioperative complications and major adverse cardiac events, mainly related to both their preoperative status and type of surgical procedure. Postoperative exercise based cardiac rehabilitation (CR) is an effective therapy to prolong survival and improve quality of life. However, little is known about the effect on post-operative complications, quality of life and return to work of a combined pre- and post-operative CR program encompassing physical therapy, dietary counseling, psychological support and life style management compared to a CR program, which is provided only after cardiac surgery.
Objective:
to determine whether a pre- and postoperative (PRE+POST) CR program improves the short (up to three months) and long term outcomes (up to one year) of the cardiac surgery (i.e. reduction in postoperative surgical complications, readmissions to hospital and major adverse cardiac events in conjunction with improvements in the physical component of health related quality of life), when compared to postoperative CR only (POST).
Study design:
A Prospective Randomized Open controlled trial, Blinded End-point. Patients are randomized between two standard care CR programs. One group will start a the POST CR program after surgery. The other group will be randomized to a combined PRE+POST CR program.
Study population:
Patients (age > 18 years) admitted for elective coronary bypass surgery, valve surgery and/or aortic surgery
Main study parameters/endpoints:
The primary outcome is a composite weighted endpoint of postoperative surgical complications, re-admissions to hospital, major adverse cardiac events and health related quality of life (two domains: physical functioning and physical problem), at three months and one year after surgery. Endpoints are determined by an independent endpoint committee, blinded to the group allocation. Secondary, the study focuses on physical health (cardiorespiratory fitness, muscle strength and functional status), psychological health (feelings of anxiety and depression), work participation, economics, lifestyle risk factors (physical activity and smoking behavior), self-efficacy and illness representations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre+postoperative Cardiac rehabilitation | Experimental | Behavioral: Pre+post-operative Cardiac rehabilitationreceive a cardiac rehabilitation program consisting of three phases. 1) A preoperative optimization phase (3x p/wk, 4-6 weeks, before surgery), 2) a postoperative in-patient phase (15 to 18 days in rehabilitation center, weekend at home) and, 3) an outpatient patient clinical rehabilitation phase (2x p/wk, 4 weeks). During each phase, patients will visit a physical therapist (group sessions of inspiratory muscle training (IMT), strength training, aerobic cycling and breath, cough and relaxation sessions), a dietician and a psychologist to optimize general health and receive advice on lifestyle, anxiety and stress management. Two additional components are coaching to stop smoking |
| Postoperative Cardiac rehabilitation | Active comparator | Behavioral: Postoperative Cardiac rehabilitationPatients who are randomized to the POST group receive an out-patient cardiac rehabilitation program after surgery. In general, this program starts three to six weeks after discharge (phase ǀǀ) and patients always start with an exercise program, which is supervised by a physical therapist for about six weeks (twice a week). On indication support of psychological and/or dietary consult is added. |
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 admitted to the department of Thoracic Surgery of the UMCG for:
- coronary artery bypass graft surgery
- valve surgery
- aortic surgery
- or a combination of the surgeries mentioned above
Key exclusion criteria (7 listed)
- Patients accepted for transcatheter aortic valve implantation (TAVI)
- Patients undergoing congenital heart surgery
- Aortic descendens or dissections surgery
- Elite athletes
- Co-morbidities that prevent participation in one or more program elements (e.g. disorders to the nervous or musculoskeletal system that limits exercise capacity, severe COPD (GOLD class 3-4), addiction to alcohol or drugs/ serious psychiatric illness) or when it is undesirable to exercise (e.g. cardiomyopathy/morrow).
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 |
|---|---|---|
| Pre+post-operative Cardiac rehabilitationAlso: Exercise, physical fitness, nutrition, psychological supportCR has the aim to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions (BACPR, 2012). | Behavioural | Pre+postoperative Cardiac rehabilitation |
| Postoperative Cardiac rehabilitationAlso: Exercise, physical fitness, nutrition, psychological supportCR has the aim to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions (BACPR, 2012). | Behavioural | Postoperative Cardiac rehabilitation |
Primary outcome
a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events
Time frame: Up to one year post-surgery
Each event, complication or worsening in functional status are considered as a score of 1 to 3 points. These points are summed to calculate the total score.
15 secondary outcomes
Atrial fibrillation
Time frame: up to one year post-surgery
prolonged stay at the intensive care unit
Time frame: up to one year post-surgery
re-thoracotomy
Time frame: up to one year post-surgery
re-admissions to intensive care unit
Time frame: up to one year post-surgery
re-admissions to hospital
Time frame: up to one year post-surgery
All-cause mortality
Time frame: up to five year post-surgery
six minutes walking test
Time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
muscle strength
Time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
functional status (KATZ)
Time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Quality of life (Rand-36-v2)
Time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Depression (PHQ-9)
Time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year post-surgery
Anxiety (GAD)
Time frame: Baseline, one day before surgery, 4-7 days, 3-4 months and one year after surgery
iMTA Productivity Cost Questionnaire (PCQ)
Time frame: Baseline, 3-4, 7-8 and 12 months post-surgery
iMTA Medical Cost Questionnaire (MCQ)
Time frame: Baseline, 3-4, 7-8 and 12 months post-surgery
Lifestyle risk factors
Time frame: Baseline, 3-4 months and one year post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Derived from this study: PubMed 31537574Hartog J, Blokzijl F, Dijkstra S, DeJongste MJL, Reneman MF, Dieperink W, van der Horst ICC, Fleer J, van der Woude LHV, van der Harst P, Mariani MA. Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life (Heart-ROCQ): study protocol for a prospective, randomised, open, blinded endpoint (PROBE) trial. BMJ Open. 2019 Sep 18;9(9):e031738. doi: 10.1136/bmjopen-2019-031738.
- 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.
MA Mariani, MD, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre+post-operative Cardiac rehabilitation and Postoperative Cardiac rehabilitation in people with Coronary (Artery); Disease and Aortic Valve Stenosis, run by University Medical Center Groningen at 1 site in Netherlands.
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 7 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: status not confirmed, as of the sponsor's last update on 30 Apr 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MA Mariani, MD, PhD (0031503613238, m.mariani@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a composite weighted score of functional status, postoperative surgical complications, re-admissions to hospital and major adverse cardiac events (time frame: Up to one year post-surgery). 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 NCT02984449, which also lists 1 linked publication.
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 30 Apr 2019.