To assess whether an extension of the cardiac rehabilitation program with telemonitoring guidance results in better long term effects on physical and mental outcomes than a regular follow-up period after traditional cardiac rehabilitation.
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameter/endpoint is physical fitness defined by peak oxygen uptake
obtained from an incremental maximal cycle ergometer exercise test at 12
months.
Secondary outcome
o Physical fitness (peak oxygen uptake obtained from maximal incremental cycle
ergometer exercise test) at baseline and 6 months.
o Cardiac structure and function (cardiac dimensions, systolic and diastolic
function parameters, valve disorders) at baseline and 12 months.
o General health (quality of life (KVL-H), physical functioning (IPAQ-long
version), emotional functioning (PHQ-9, HADS), social functioning (MPSS) at
baseline, 6 months and 12 months.
o Traditional risk factors (i.e. cholesterol, lipid profile, HbA1C, blood
pressure, and body characteristics) at baseline, 6 months and 12 months.
o Compliance (use of the smartphone in the intervention group for at least half
an hour at 5 five days per week during the first 6 months of the study)
o Care consumption ((days) admission, outpatient clinic visits, GP visits,
interventions, radiology, nuclear and lab testing) collected throughout the
study period.
o Major Adverse Cardiovascular Events (cardiovascular (CV) mortality, all-cause
mortality, near sudden cardiac death, acute coronary syndrome, CV
intervention/surgery, CV hospital admission, CV Emergency visits) collected
throughout the study period.
Background summary
Cardiovascular diseases (CVDs) are the leading cause of death and a major cause
of disability and loss of productivity in adults worldwide. In the Netherlands,
the substantial burden of CVD is further exemplified by an estimated 45%
increase of the number of patients with CVD from 2007-2025. Compliance to
physical activity after cardiac rehabilitation, which is generally limited to
12 weeks at most, is found to be relatively low and less than half of the
patients continue their physical training after initial rehabilitation. In
addition to this, it has been shown that 44% of patients that underwent the
standard cardiac rehabilitation program in the Netherlands required
rehospitalization within five years.
The problem of low compliance to physical training after regular cardiac
rehabilitation is often caused by the transition from a supervised to an
unsupervised environment. In order to achieve long term effects on physical
fitness and activity, patients need more guidance in this transition phase. On
the short term, programs with telehealth interventions seem to be effective in
improving self-management skills and provide an effective risk factor reduction
and secondary prevention. However, long term effectiveness of telehealth
interventions are still not known.
Study objective
To assess whether an extension of the cardiac rehabilitation program with
telemonitoring guidance results in better long term effects on physical and
mental outcomes than a regular follow-up period after traditional cardiac
rehabilitation.
Study design
Randomized clinical trial
Intervention
The intervention of the study starts when patients finish their initial cardiac
rehabilitation program. Patients participating in the extended cardiac
rehabilitation program with telemonitoring will undergo 6 months of
telemonitoring guidance and in addition another 6 months without
telemonitoring. The telemonitoring group will receive instructions before they
start training with a heart rate monitor in their home environment. Patients
are instructed to perform a moderate exercise 5 days per week for at least half
an hour.
Study burden and risks
Noninvasive cardiac testing procedures in this study are not related to any
potential risk for the participant. Maximal cycling tests will be performed at
the hospital under supervision of highly qualified personnel.
A possible complication of venipuncture is a hematoma, which is induced in ~5%
of all cases. To prevent complications, an experienced professional will
perform the blood withdrawal and sufficient pressure will be provided after
withdrawal of the needle. As patients are included in the study after
participation in the standard cardiac rehabilitation program we expect no
potential risk for them to exercise in their home environment.
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- Patients participating in cardiac rehabilitation (minimal attendance of 80% in physical program)
- Signed written informed consent
- One of the following criteria:
o Patients with an acute coronary syndrome, including myocardial infarction (MI) within 3 months
prior to start cardiac rehabilitation program
o Patients that underwent a percutaneous coronary intervention (PCI) within 3 months prior to
prior to start cardiac rehabilitation program
o Patients that received coronary artery bypass grafting (CABG) within 3 months prior to start
cardiac rehabilitation program
Exclusion criteria
- Contraindication to cardiac rehabilitation
- Mental impairment leading to inability to cooperate
- Severe impaired ability to exercise
- Signs of cardiac ischemia and/or a positive exercise testing on cardiac ischemia
- Insufficient knowledge of the Dutch language
- No access, availability or insufficient knowledge of a computer with internet
- Implanted cardiac device (pacemaker, ICD)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48475.075.14 |