- Elderly frail patients with acute decompensated heart failure hospitalizations benefit from cardiac rehabilitation
- Tailored rehabilitation led to a large, significant improvement in Short Physical Performance Battery (SPPB) score which was relatively uniform across pre-specified subgroups
- Rehabilitation intervention patients saw large, significant, clinically meaningful improvements in 6-minute walk distance, quality-of-life, Fried Frailty score, and depression
Older people with acute decompensated heart failure (ADHF) suffer from poor quality of life, frequent rehospitalizations, loss of independence and high mortality. Physical dysfunction may be contributing to these poor outcomes but is often overlooked as a possible mechanism. In recent years, advocacy groups within the American College of Cardiology have made a concerted effort to increase access for adults to cardiac rehabilitation. The REHAB-HF trial (NCT02196038), presented as a Late Breaking Clinical Trial on May 16th at ACC, contributes to a growing body of literature supporting improvement of physical function through cardiac rehabilitation for older adults with ADHF.
REHAB-HF sought to evaluate whether physical rehabilitation for older adults would improve outcomes amongst patients with ADHF. The trial’s investigative team, led by Dr. Dalane Kitzman of Wake Forest University Health Sciences, note that both frailty and reduced physical function are major determinants of adverse outcomes in older ADHF patients, however these issues are not adequately addressed by current heart failure (HF) management strategies. They led a multi-center, randomized, attention-controlled, single-blind trial in which 360 patients ≥60 years hospitalized with ADHF were randomized either to a novel 12-week multi-domain physical rehabilitation intervention beginning early during hospitalization or to attention control. The intervention arm received endurance, mobility, strength, and balance training which was tailored to patient performance, began during hospitalization, and continued 3 times weekly in the outpatient setting for a total of 12 weeks. Patients continued unsupervised exercise at home 5 times weekly for 3 additional months. The attention control arm received usual care as well as bi-weekly contact from study staff followed by telephone contact in the final 3 months.
In his presentation, Dr. Kitzman noted that the inclusion criteria were broad to include as many adults as possible. They included adequate clinical stability to participate in the study, independence with basic activities of daily living and ambulation, and ability to walk 4 meters (with cane or walker allowed).
All participants underwent measures of physical function and quality of life at baseline, 1 month, and 3 months. Clinical events were monitored for 6 months following the index hospitalization. The primary trial aim was to assess the efficacy of the rehabilitation intervention on physical function measured by total Short Physical Performance Battery (SPPB) score. This score is known to be a strong predictor of a wide range of outcomes and has been validated in several similar studies. SPPB was assessed by a blinded observer. The secondary outcome was 6-month all-cause rehospitalization. Additional outcome measures included quality of life and costs.
The results of the REHAB-HF trial, published simultaneously in the New England Journal of Medicine (https://www.nejm.org/doi/full/10.1056/NEJMoa2026141) indicate overwhelming success of the rehabilitation intervention. Intervention retention and adherence were excellent at 82% and 78%, respectively. Retention for the secondary outcome was 99%. Three serious safety events possible related to the intervention took place, all self-limited.
Amongst this diverse, elderly, frail population, the study found that functioning improved for all domains of the intervention including balance, strength, mobility and endurance. SPPB, which ranges from 0 at the lowest level of functioning to 12 which is normal, was 6.1 on average at baseline. Practically, this score indicates that at baseline these patients were at the margin of ability to maintain independence which is typical of a nursing home population. After 3 months, the control group showed only a small improvement in their physical functioning after discharge. Dr. Kitzman notes, “These results suggest that patients who have ADHF hospitalizations have long-term disability that does not improve on its own.” The intervention arm however showed a large and significant improvement compared to control with an effect size of 1.5 units, 3 times larger than the minimal clinically meaningful difference of 0.5. These improvements in SPPB amongst the intervention arm were seen uniformly amongst pre-specified subgroups which included women and patients with all types of HF. The intervention arm also increased their 6-minute walk distance significantly by nearly 20%. Other significant improvements were seen in the intervention group in parameters that included the Kansas City Cardiomyopathy Questionnaire, frailty, and depression.
All-cause or heart failure rehospitalizations, and the combined endpoint of all cause rehospitalization and death were numerically lower in the intervention group but were not significantly different.
These clinical events were common amongst both populations. Numerically more deaths were observed in the rehabilitation intervention group however the number overall was small, and no significant differences were seen. The author notes that the study was underpowered to detect clinical events.
This trial was made possible via a National Institute on Aging grant (R01-AG045551).