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ID
Source
Brief title
Health condition
Congestive heart failure
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is physical functional capacity described using the Short Physical Performance Battery (SPPB) score, which is assessed at week 0, week 18 and week 26.
Secondary outcome
Secondary endpoints are recovery after submaximal exercise by evaluating VO2 recovery kinetics (tau-rec), subjective health status evaluated with Kansas City Cardiomyopathy Questionnaire (KCCQ-12), health related quality of life (HRQOL) evaluated with the Minnesota Living with Heart Failure Questionnaire (MLHFQ), compliance and acceptance to the rehabilitation program, and readmission rate.
Background summary
Cardiac rehabilitation (CR) has favourable effects in chronic heart failure (CHF) patients on exercise capacity, the risk at hospital (re-)admission and quality of life. Although CR is generally recommended, it is still under-utilized in daily clinical practice mainly due to patient related factors (e.g. dependence on others for transportation, high level of disability). We hypothesize that comprehensive home-based rehabilitation with remote guidance (cardiac telerehabilitation, CTR) tailored to individual disabilities has beneficial effects on the functional capacity in patients after hospital admission due to acute decompensated heart failure.
Study objective
We hypothesize that comprehensive home-based rehabilitation with remote guidance (cardiac telerehabilitation, CTR) tailored to individual disabilities has beneficial effects on the functional capacity in patients after hospital admission due to acute decompensated heart failure.
Study design
Inclusion: during admission to the hospital primarily due to acute decompensated heart failure (ADHF).
Pre-intervention: uptitration of heart failure medication, follow-up with Remote Patient Monitoring (RPM).
Randomization: after stabilization and first outcome measurement (T0) the participants will be randomized to control or intervention group.
Intervention: 18 weeks telerehabilitation program vs. no rehabilitation.
T1: 18 weeks after start intervention.
T2: 26 weeks (6 months) after starting the intervention.
Intervention
An 18-weeks multidisciplinary telerehabilitation program with exercise training by physical and occupational therapist, supported by a (remote) technology-assisted dietary intervention and mental health guiding by a physiologist. The training program starts with three centre-based and two home-based video exercise training sessions followed by video coaching sessions. The mental health and dietary program are executed using individual and group video sessions.
Inclusion criteria
- Age 18 years and above
- Diagnosed with congestive heart failure
- Hospitalization primarily for acute decompensated heart failure (ADHF) at the time of inclusion
- Sufficient digital capacity or caretaker with digital capacity
- Able to speak and read the Dutch language
Exclusion criteria
- Unable to understand the purpose and procedures of the study
- Unable to mobilize (e.g. due to orthopaedic limitations)
- Recent CR program followed (latest 12 months)
- No internet connection
- Untreated life-threatening cardiac arrhythmias
- Early phase after acute coronary syndrome (latest 3 months)
- Uncontrolled hypertension
- Advanced atrioventricular block
- Symptomatic aortic stenosis
- Up-coming (cardiac) surgery in 6 months
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9619 |
| CCMO | NL78154.015.21 |
| OMON | NL-OMON56416 |