The aim of this observational study is to obtain the evidence base to improve CR programmes regarding sustainable effectiveness, cost-effectiveness and participation level in elderly patients, by comparing 8 currently available CR programmes. The…
ID
Source
Brief title
Condition
- Myocardial disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Physical fitness:
- Difference in peak oxygen uptake obtained from an incremental exercise test
(T1-T0)
Secondary outcome
Physical fitness:
- Difference in peak oxygen uptake obtained from an incremental exercise test
(T2-T0)
- Difference in peak oxygen uptake obtained from an incremental exercise test
(T2-T1)
Traditional risk factors:
- Changes in lipid profile (T1-T0, T2-T0, T2-T1)
- Changes in HbA1C (T1-T0, T2-T0, T2-T1)
- Changes in renal function (T1-T0, T2-T0, T2-T1)
- Changes in lean body mass (T1-T0, T2-T0, T2-T1)
- Changes in blood pressure (T1-T0, T2-T0, T2-T1)
- Changes in smoking habit (T2-T0)
Major Adverse Cardiovascular Events (MACE):
- The occurrence of events (cardiovascular (CV) mortality, all-cause mortality,
near sudden cardiac death, ACS, CV intervention/surgery, CV hospital admission,
CV emergency visits) as composite endpoint (T2-T0) are registered and collected
by monthly telephone calls.
General health:
- Difference in depression score assessed by: PHQ-9 questionnaire (T1-T0,
T2-T0, T2-T1)
- Difference in anxiety score assessed by GAD-7 questionnaire (T1-T0, T2-T0,
T2-T1)
- Quality of Life: SF-36v2, difference in Physical Component Summary Score and
Mental Component Summary Score (T1-T0, T2-T0, T2-T1)
- Difference in dietary pattern (reflected by total score and score on
individual components) assessed by Mediterranean Diet Score (T1-T0, T2-T0,
T2-T1)
- Care utilisation as composite endpoint of: (number of) admissions, emergency
visits and cardiac interventions (PCI, CABG) (T2-T0)
- Costs of care utilisation based on activities (clinical admission days,
emergency and outpatient clinic visits, GP visits for cardiac (related)
complaints or issues, radiology/cardiophysiology/nuclear and laboratory tests,
and cardiac interventions) registered at T0, T1 and T2 and collected by monthly
telephone calls with the participants between T1 and T2
Adherence:
- The occurrence of drop-outs (including reason for drop-out) or completed CR
is registered per CR programme throughout the study period.
Compliance:
- Percentage of attended training sessions is registered per CR programme.
Background summary
Cardiovascular diseases (CVDs) are still the leading cause of death in Europe
and a major cause of disability and loss of productivity in adults worldwide,
this comes down to more than 4 million deaths each year in Europe. The
substantial burden of CVD is further exemplified by a huge economic strain.
Costs of CVD in the European Union are estimated at ¤169 billion annually, with
healthcare costs accounting for 54% of the costs.
Literature shows that cardiac rehabilitation (CR) is highly effective, but
knowledge on the effectiveness of individual CR components and appropriateness
for specific patient groups (young versu elderly) is limited. CR is currently
underused by elderly (in comparison to the younger population) and the effects
of these programmes are underestimated by professionals. The current approach
of CR is often less appropriate for the elderly, and as a result of which
effectiveness, compliance, participation levels and cost-utility of CR
programmes is hampered.
Study objective
The aim of this observational study is to obtain the evidence base to improve
CR programmes regarding sustainable effectiveness, cost-effectiveness and
participation level in elderly patients, by comparing 8 currently available CR
programmes. The sustainability of CR programmes will be analysed by adding a
follow-up period after the end of the regular CR programmes.
Study design
A prospective cohort study
Study burden and risks
Non-invasive cardiac testing procedures in this study are not related to any
potential risk for the participant. All procedures are performed routinely at
the departments and are part of usual care. Incremental maximal exercise 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 participating in existing CR
programmes (based on the current guidelines) we expect no additional risk by
joining the study.
Dokter van Heesweg 2
AB Zwolle 8025
NL
Dokter van Heesweg 2
AB Zwolle 8025
NL
Listed location countries
Age
Inclusion criteria
- Patients of 65 years or older who have accepted CR
- Signed written informed consent
- One of the following criteria:
o Patients with an ACS, including MI and/or revascularisation within 3 months prior to the start of the CR programme
o Patients that underwent a PCI within 3 months prior to the start of the CR programme
o Patients that received CABG within 3 months prior to the start of the CR programme
o Patients who were treated surgically or percutaneously for valvular heart disease (including (including Transcatheter Aortic Valve Implantation) within 3 months prior to the start of the CR programme
o Patients with a stable angina with documented significant coronary artery disease (defined by standard non-invasive or invasive methods)
Exclusion criteria
- Contraindication to CR
- Mental impairment leading to inability to cooperate
- Severe impaired ability to exercise
- Signs of severe cardiac ischemia and/or a positive exercise testing on severe cardiac ischemia
- Insufficient knowledge of the native language
- Implanted cardiac device (CRT-P, 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 | NL52816.075.15 |