Cardiac RehabilitationREHAB+NCT05207072
Mobile Tele-Monitoring Guided Cardiac Rehabilitation in Post-Acute Coronary Syndrome Patients
An observational study of Cardiac Rehabilitation and Acute Coronary Syndrome, run by Maastricht University at 4 sites in 2 countries.
Trial summary
Cardiac rehabilitation (CR) programmes are effective measures to reduce recurrent ischemic events in post-acute coronary syndrome (ACS) patients. However, participation rates in CR programmes following myocardial infarction remain low and their long-term effects are uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Acute Coronary Syndrome
- How many people
- 900 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 6 Dec 2021to 1 Dec 2023
- Phase
- Observational
- 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
Study population: Subjects of 18 years or older following acute myocardial infarction.
Who may be able to join
- Subjects of 18 years or older who are a candidate for CR with the following criteria:
- Patients with a myocardial infarction (both STEMI and NSTEMI);
- Signed written informed consent.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Contraindication to CR;
- Mental impairment leading to inability to cooperate;
- Severe impaired ability to exercise;
- participating in a cardiac rehabilitation programme at the time of inclusion;
- Insufficient knowledge of the native language;
- Participating in CR elsewhere.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites, 3 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona
J. Lozano Torres, MD
- Not yet recruiting
Hospital Universitario La Paz
Madrid
A Castro conde, MD
- Not yet recruiting
Hospital Virgen de la Victoria de Málaga
Málaga
J Gomes Doblas, MD
Netherlands1 site, 1 recruiting
- Recruiting
Stichting Zuyderland Medisch Centrum
Heerlen, Limburg, 6419PC
C Hoorntje, MD
About this study
Official title: Prospective Observational Trial for a Cardiac Rehabilitation eHealth Application in Post-ACS Patients; Assessment of the Effects on Sustainability and Participation Level (REHAB+)
Cardiac rehabilitation (CR) programmes are effective measures to reduce recurrent ischemic events in post-acute coronary syndrome (ACS) patients. However, participation rates in CR programmes following myocardial infarction remain low and their long-term effects are uncertain.
Home-based CR in combination with novel innovative e-Health applications could overcome barriers to accessibility and participation. Rehab+, a mobile cardiac rehabilitation (mCR) programme co-created with patients and rehabilitation centres, is designed to future-proof CR and to make CR more accessible to patients. Moreover, Rehab+ will be offered for 12 consecutive months after myocardial infarction and could therefore result in greater sustained effects.
Read more
This prospective, investigator-initiated, multicentre, matched control, observational trial intends to enroll 900 post-ACS patients. Subjects following ACS will be enrolled in the hospital if they meet all the eligibility criteria. Each subject will be able to choose between one of the 2 treatment groups, i.e. 12 months of mCR or 6-8 weeks of traditional centre-based CR. The follow-up for each subject will take 12 months for both groups.
The primary objective of this study is to assess whether mCR programme result in better sustained effects on physical, mental and social outcomes in post-ACS patients, as compared to post-ACS patients who follow the traditional CR programme.
The main hypothesis is that mCR is expected to result in greater improvement in Quality of Life at 12 months as compared to traditional CR.
Read the detailed description
Subjects will be screened during hospitalisation following myocardial infarction. All eligible patients for CR will be informed about the study and requested to participate. Those fulfilling the eligibility criteria who have provided written informed consent will be allocated based upon patient preference to the mCR group with mobile tele-monitoring guidance or the control group following the regular CR programme.
Patient data will be collected at three different time points, T0 at inclusion (baseline), T1 after 3 months and T2 after 12 months. Data will be administered from the patient's (electronic) health record collected during usual care. Extra data will be administered through questionnaires.
Patients can leave the study at any time for any reason if they wish to do so without any consequences. The site investigator can decide to withdraw a patient from the study for urgent medical reasons.
In order to assess the effects on sustained physical fitness after participation in the mCR programme it was determined that an inclusion of 300 patients per group would be sufficient to examine the aim of this study.
This is based on the expected difference in increase in Quality of Life at 12 months between the mCR and matched traditional CR group with an estimated standard deviation of 7 units (Physical component score SF-36 questionnaire) in both groups. The base correlation is expected to be 0.5. Assuming 80% power and 5% two-sided significance level (alpha=0.05), the sample size (n) required to achieve a probability of 80% of detecting a difference in the QoL level between two groups, is n=268 per group.
Based on 10% withdrawal or incomplete data, the investigators aim for a group size of n= 300 per group (n=600 in total). In order to find a control group of 300 matched patients, 600 consecutive patients following regular CR will be registered. The investigators expect patients choosing for mCR versus regular CR in a ratio of 1:2. Therefore a total of 900 patients will be included in the study.
- Conditions
- Cardiac Rehabilitation, Acute Coronary Syndrome
- Keywords
- Cardiac Telerehabilitation, Acute Coronary Syndrome, Cardiac Rehabilitation
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Cardiac Rehabilitation (mCR) group | The mCR programme involves a home-based programme for 12 months in which patients are supplied with a smartphone/application with a data subscription from LIVA. Through this application patients are able to measure and register physical activity, heart frequency and intensity (BORG scale) and can monitor progress. A healthcare professional (coach) also has access to a portal to monitor progress of different patients, advice on rehabilitation approach and stimulate compliance. Together with their coaches every patient makes their own rehabilitation programme. Patients will be coached for 12 months starting intensively with decreasing amounts of contacts over time. | |
| Traditional Cardiac Rehabilitation (CR) group | The traditional CR programme involves standard a standard CR programme over a 6-8 weeks period. Subjects receive no advice or coaching after the end of the traditional CR program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of Life measured by the SF-36 questionnaire.
Short Form 36 (SF-36) quality of life scale will be used to evaluate health-related quality of life between the end of follow-up (T2) and baseline (T0). Items are grouped in 8 scaled scores exploring multiple dimensions of health (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).
Scoring will be performed as recommended by the SF-36 instruction manual to create the eight scale scores. Furthermore, these subscales sum to obtain the total SF-36 score and will be summarized into two composite scores (physical and mental quality of life).
Measured: At 12 months (T2) and baseline (T0)
Secondary outcomes (8)
Change in Quality of Life measured by the SF-36 questionnaire.
Short Form 36 (SF-36) quality of life scale will be used to evaluate health-related quality of life between 3 months (T1) and baseline (T0). Items are grouped in 8 scaled scores exploring multiple dimensions of health (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).
Scoring will be performed as recommended by the SF-36 instruction manual to create the eight scale scores. Furthermore, these subscales sum to obtain the total SF-36 score and will be summarized into two composite scores (physical and mental quality of life).
Measured: At 3 months (T1) and baseline (T0)
Rate of re-hospitalization or visits to the emergency department.
The occurrence of re-hospitalizations or visits to the emergency department between baseline and the end of follow-up.
Measured: At 12 months (T2)
Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ).
The IPAQ short form (IPAQ-sf) with an activity diary (in minutes/week) will be used to evaluate the physical activity level of the participants. Results will be reported in categories (low activity levels, moderate activity levels or high activity levels).
Measured: At 12 months (T2), 3 months (T1) and baseline (T0)
Self-reported impact of eHealth on its users measured by the e-Health Impact Questionnaire (eHIQ).
The eHealth Impact Questionnaire (eHIQ) measures users' attitudes towards an application which they recently viewed. It is divided into the 11-item eHIQ-Part 1, asking for general attitudes towards using the internet to access health information and the 26-item eHIQ-Part 2, which is related to the effects of using a specific health-related application on three subscales: 1) confidence and identification, 2) information and presentation and 3) understanding and motivation. Both answering formats range from 1 (strongly disagree) to 5 (strongly agree). Part 1 will be assessed in both groups, while part 2 will only be assessed in the mCR group.
Measured: At 3 months (T1)
Change in metabolic equivalent of task (MET) as calculated from treadmill or cycle ergometry.
Physical fitness level will be measured as number of MET during an incremental maximal exercise test (cycling or treadmill). The test will be performed under supervision. All tests will be performed by the same protocol. For patients who are not able to participate cycling test, this test will be replaced by the treadmill Test. The testing modality chosen per centre at T0, will remain the same at T2. To ensure a safe environment in which the tests can be performed, the test will be performed to applicable guidelines and regulations within each participating centre.
Measured: At 12 months (T2) and baseline (T0)
Change in lipid profile
Blood samples as part of standard care will be obtained to assess changes in lipid profiles (in mmol/L).
Measured: At 12 months (T2), at 3 months (T1) and at baseline (T0)
Change in HbA1c
Blood samples as part of standard care will be obtained to assess changes in HbA1c (in mmol/mol).
Measured: At 12 months (T2), at 3 months (T1) and at baseline (T0)
Change in smoking (tobacco addiction) according to the Fagerström test.
The Fagerström test consists of six questions. The minimum value is 0 points and maximum values is 10 points. The higher score represents the greater nicotine dependence.
Measured: At 12 months (T2), at 3 months (T1) and at baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start6 Dec 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (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 Cardiac RehabilitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AWJ van t Hof, Maastricht University
- Investigators
- Arnoud van 't Hof, MD PhD, Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05207072
- Sponsor's protocol ID
- Z20210177
- Other IDs
- 210707
- Acronym
- REHAB+
- Status last verified
- Jan 2022
- First submitted
- 24 Dec 2021
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van Mierlo RFR, Houben VJG, Rikken SAOF, Gomez-Doblas JJ, Lozano-Torres J, van 't Hof AWJ. Cardiac (tele)rehabilitation in routine clinical practice for patients with coronary artery disease: protocol of the REHAB + trial. Front Cardiovasc Med. 2024 Jul 29;11:1387148. doi: 10.3389/fcvm.2024.1387148. eCollection 2024.
PubMed 39224752
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Trial for a Cardiac Rehabilitation eHealth Application in Post-ACS Patients; Assessment of the Effects on Sustainability and Participation Level (REHAB+)
- ClinicalTrials.gov ID
- NCT05207072
- Acronym / sponsor ID
- REHAB+ / Z20210177
- Conditions
- Cardiac Rehabilitation, Acute Coronary Syndrome
- Keywords
- Cardiac Telerehabilitation, Acute Coronary Syndrome, Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Maastricht UniversityUniversity, hospital or other
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 Jan 2022 (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.
Cardiac rehabilitation (CR) programmes are effective measures to reduce recurrent ischemic events in post-acute coronary syndrome (ACS) patients. However, participation rates in CR programmes following myocardial infarction remain low and their long-term effects are uncertain.
Home-based CR in combination with novel innovative e-Health applications could overcome barriers to accessibility and participation. Rehab+, a mobile cardiac rehabilitation (mCR) programme co-created with patients and rehabilitation centres, is designed to future-proof CR and to make CR more accessible to patients. Moreover, Rehab+ will be offered for 12 consecutive months after myocardial infarction and could therefore result in greater sustained effects.
This prospective, investigator-initiated, multicentre, matched control, observational trial intends to enroll 900 post-ACS patients. Subjects following ACS will be enrolled in the hospital if they meet all the eligibility criteria. Each subject will be able to choose between one of the 2 treatment groups, i.e. 12 months of mCR or 6-8 weeks of traditional centre-based CR. The follow-up for each subject will take 12 months for both groups.
The primary objective of this study is to assess whether mCR programme result in better sustained effects on physical, mental and social outcomes in post-ACS patients, as compared to post-ACS patients who follow the traditional CR programme.
The main hypothesis is that mCR is expected to result in greater improvement in Quality of Life at 12 months as compared to traditional CR.
Detailed description
Subjects will be screened during hospitalisation following myocardial infarction. All eligible patients for CR will be informed about the study and requested to participate. Those fulfilling the eligibility criteria who have provided written informed consent will be allocated based upon patient preference to the mCR group with mobile tele-monitoring guidance or the control group following the regular CR programme.
Patient data will be collected at three different time points, T0 at inclusion (baseline), T1 after 3 months and T2 after 12 months. Data will be administered from the patient's (electronic) health record collected during usual care. Extra data will be administered through questionnaires.
Patients can leave the study at any time for any reason if they wish to do so without any consequences. The site investigator can decide to withdraw a patient from the study for urgent medical reasons.
In order to assess the effects on sustained physical fitness after participation in the mCR programme it was determined that an inclusion of 300 patients per group would be sufficient to examine the aim of this study.
This is based on the expected difference in increase in Quality of Life at 12 months between the mCR and matched traditional CR group with an estimated standard deviation of 7 units (Physical component score SF-36 questionnaire) in both groups. The base correlation is expected to be 0.5. Assuming 80% power and 5% two-sided significance level (alpha=0.05), the sample size (n) required to achieve a probability of 80% of detecting a difference in the QoL level between two groups, is n=268 per group.
Based on 10% withdrawal or incomplete data, the investigators aim for a group size of n= 300 per group (n=600 in total). In order to find a control group of 300 matched patients, 600 consecutive patients following regular CR will be registered. The investigators expect patients choosing for mCR versus regular CR in a ratio of 1:2. Therefore a total of 900 patients will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Cardiac Rehabilitation (mCR) group | – | –The mCR programme involves a home-based programme for 12 months in which patients are supplied with a smartphone/application with a data subscription from LIVA. Through this application patients are able to measure and register physical activity, heart frequency and intensity (BORG scale) and can monitor progress. A healthcare professional (coach) also has access to a portal to monitor progress of different patients, advice on rehabilitation approach and stimulate compliance. Together with their coaches every patient makes their own rehabilitation programme. Patients will be coached for 12 months starting intensively with decreasing amounts of contacts over time. |
| Traditional Cardiac Rehabilitation (CR) group | – | –The traditional CR programme involves standard a standard CR programme over a 6-8 weeks period. Subjects receive no advice or coaching after the end of the traditional CR program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects of 18 years or older following acute myocardial infarction.
Key inclusion criteria (3 listed)
- Patients with a myocardial infarction (both STEMI and NSTEMI);
- Signed written informed consent.
Key exclusion criteria (7 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Contraindication to CR;
- Mental impairment leading to inability to cooperate;
- Severe impaired ability to exercise;
- participating in a cardiac rehabilitation programme at the time of inclusion;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Quality of Life measured by the SF-36 questionnaire.
Time frame: At 12 months (T2) and baseline (T0)
Short Form 36 (SF-36) quality of life scale will be used to evaluate health-related quality of life between the end of follow-up (T2) and baseline (T0). Items are grouped in 8 scaled scores exploring multiple dimensions of health (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health). Scoring will be performed as recommended by the SF-36 instruction manual to create the eight scale scores. Furthermore, these subscales sum to obtain the total SF-36 score and will be summarized into two composite scores (physical and mental quality of life).
8 secondary outcomes
Change in Quality of Life measured by the SF-36 questionnaire.
Time frame: At 3 months (T1) and baseline (T0)
Rate of re-hospitalization or visits to the emergency department.
Time frame: At 12 months (T2)
Change in physical activity as measured by the International Physical Activity Questionnaire (IPAQ).
Time frame: At 12 months (T2), 3 months (T1) and baseline (T0)
Self-reported impact of eHealth on its users measured by the e-Health Impact Questionnaire (eHIQ).
Time frame: At 3 months (T1)
Change in metabolic equivalent of task (MET) as calculated from treadmill or cycle ergometry.
Time frame: At 12 months (T2) and baseline (T0)
Change in lipid profile
Time frame: At 12 months (T2), at 3 months (T1) and at baseline (T0)
Change in HbA1c
Time frame: At 12 months (T2), at 3 months (T1) and at baseline (T0)
Change in smoking (tobacco addiction) according to the Fagerström test.
Time frame: At 12 months (T2), at 3 months (T1) and at baseline (T0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Derived from this study: PubMed 39224752van Mierlo RFR, Houben VJG, Rikken SAOF, Gomez-Doblas JJ, Lozano-Torres J, van 't Hof AWJ. Cardiac (tele)rehabilitation in routine clinical practice for patients with coronary artery disease: protocol of the REHAB + trial. Front Cardiovasc Med. 2024 Jul 29;11:1387148. doi: 10.3389/fcvm.2024.1387148. eCollection 2024.
- Links to the REHAB+ project on the website of the grant funding organization (European Institute of Innovation and Technology).Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cardiac Rehabilitation
Recruiting
Remote Rehabilitation in Patients With HFpEF (PATRON-HF)
Heart Failure With Preserved Ejection Fraction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Not yet recruiting
King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
Heart Failure, Cardiac Rehabilitation
Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
Recruiting
Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients
Cardiovascular Diseases (CVD), Coronary Disease
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.
Arnoud van 't Hof, MD PhD principal investigator
Maastricht University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation and Acute Coronary Syndrome, run by Maastricht University at 4 sites in 2 countries.
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 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 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, 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 Vital Houben, MD (088 - 459 9718 ext. +31, v.houben@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life measured by the SF-36 questionnaire. (time frame: At 12 months (T2) and baseline (T0)). 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 NCT05207072, 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 26 Jan 2022.