To investigate if CTR in recently hospitalized congestive heart failure (CHF) patients improves their physical functional capacity when compared to usual care. Secondary objectives are recovery from submaximal exercise evaluated with a constant-load…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
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), 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).
Therefore, we hypothesize that home-based rehabilitation (cardiac
telerehabilitation, CTR) tailored to individual disabilities is an attractive
and feasible alternative for CHF patients with favourable long-term outcomes.
Study objective
To investigate if CTR in recently hospitalized congestive heart failure (CHF)
patients improves their physical functional capacity when compared to usual
care. Secondary objectives are recovery from submaximal exercise evaluated with
a constant-load test, disease specific quality of life, adherence to the
program and readmission rate.
Study design
Prospective randomised controlled trial.
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.
Study burden and risks
CR is associated with reduction of cardiovascular mortality, morbidity and
disability and increases quality of life. The additional risk from CTR is
expected to be low as previous research showed that home-based training in HF
patients is safe. To minimize potential risks, all patients start with 5
supervised training sessions, followed by a personalized home-based training
program with telemonitoring guidance.
De Run 4600
Veldhoven 5504DB
NL
De Run 4600
Veldhoven 5504DB
NL
Listed location countries
Age
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
- Severe aortic stenosis
- Up-coming major (cardiac) surgery in 3 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL78154.015.21 |
| Other | NL9619 |
| OMON | NL-OMON27821 |