| Trial Status | Open |
|---|---|
| Overall study start date | 10-08-2021 |
| Overall study end date | |
| Country | The Netherlands |
| Trial Number | NL-OMON56416 |
| Trial URL | https://onderzoekmetmensen.nl/en/trial/56416 |
| 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 Design | Prospective randomised controlled trial. |
| Study Setting(s) | Hospital, Home |
| Study Acronym | Tele-ADHF |
| Study Hypotheses | home-based rehabilitation (cardiac telerehabilitation, CTR) tailored to individual disabilities is an attractive and feasible alternative for CHF patients with favourable long-term outcomes. |
| Condition | Cardiac |
| 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. |
| Primary Outcome Measure | 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 Measure | 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. |
Eligibility
| Participant Type(s) | Cardiac |
|---|---|
| Age Group | Adult (18-64), Senior (65+) |
| Sex | Both |
| Target Number of Participants | 90 |
| Total Final Enrolment | |
| Participant 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 |
| Participant 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 |