Aim: The aim of this study is to examine the effects of a program of mind‐body interventions on psychological resilience, vagal tone, emotional states, and heart failure (HF) outcomes in patients with HF. Methods: One hundred and fifty participants will be enrolled in this randomized controlled trial. Participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive an 8‐week program of mind‐body interventions consisting of slow breathing, autogenic training, mindfulness and positive emotion enhancement. The control group will be managed in accordance with current clinical practice and receive conventional follow‐up. The primary endpoint is all‐cause mortality or all‐cause hospital admission after 3, 6, and 12 months. Secondary endpoints include HF self‐care behaviour, health‐related quality of life (HRQOL), and number of days in hospital after 6 and 12 months. Self‐care behaviour will be assessed by the Self‐care of Heart Failure Index (SCHFI) version 6. HRQOL will be assessed by the Medical Outcome Studies 36‐Item Short‐Form (SF‐36) Health Survey. To assess participants' abilities to cope effectively with adversity, the Resilience Scale (RS) will be used in this study. Depressive and anxiety symptoms will be examined by the Beck Depression Inventory‐II (BDI‐II) and the Beck Anxiety Inventory (BAI), respectively. To assess vagal tone, heart rate variability (HRV) will be tested. The RS, HRV, BDI‐II, BAI, SCHFI, and SF‐36 will be assessed at baseline, one week after the 8‐week intervention period, and after 6 months and 12 months. Expected Outcomes: It is expected that mind‐body interventions tested in this study could significantly increase the RS score and HRV, decrease scores of BDI‐II and BAI, and improve SCHFI and SF‐36. All‐cause mortality or all‐cause hospital admission and number of days in hospital after 3, 6, and 12 months are expected to be lower in the intervention group compared with the control group. The cumulative risk of death after 12 months is expected to be lower in the intervention group after adjusting for the Charlson Comorbidity Index alone or adjusting for all possible confounders compared with the control group.
|Effective start/end date||8/1/13 → 7/31/14|
- Emotional States
- Health‐Related Quality of Life
- Heart Failure
- Mind‐body interventions
- Survival Analysis
- Vagal Tone