Effects of hybrid comprehensive telerehabilitation on cardiopulmonary capacity in heart failure patients depending on diabetes mellitus: subanalysis of the TELEREH-HF randomized clinical trial

Abstract

Background: Type 2 diabetes mellitus (DM) is one of the most common comorbidities among patients with heart failure (HF) with reduced ejection fraction (HFrEF). There are limited data regarding efficacy of hybrid comprehensive telerehabilitation (HCTR) on cardiopulmonary exercise capacity in patients with HFrEF with versus those without diabetes.

Aim: The aim of the present study was to analyze effects of 9-week HCTR in comparison to usual care on parameters of cardiopulmonary exercise capacity in HF patients according to history of DM.

Methods: Clinically stable HF patients with left ventricular ejection fraction [LVEF] < 40% after a hospitalization due to worsening HF within past 6 months were enrolled in the TELEREH-HF (The TELEREHabilitation in Heart Failure Patients) trial and randomized to the HCTR or usual care (UC). Cardiopulmonary exercise tests (CPET) were performed on treadmill with an incremental workload according to the ramp protocol.

Results: CPET was performed in 385 patients assigned to HCTR group: 129 (33.5%) had DM (HCTR-DM group) and 256 patients (66.5%) did not have DM (HCTR-nonDM group). Among 397 patients assigned to UC group who had CPET: 137 (34.5%) had DM (UC-DM group) and 260 patients (65.5%) did not have DM (UC-nonDM group). Among DM patients, differences in cardiopulmonary parameters from baseline to 9 weeks remained similar among HCTR and UC patients. In contrast, among patients without DM, HCTR was associated with greater 9-week changes than UC in exercise time, which resulted in a statistically significant interaction between patients with and without DM: difference in changes in exercise time between HCTR versus UC was 12.0 s [95% CI - 15.1, 39.1 s] in DM and 43.1 s [95% CI 24.0, 63.0 s] in non-DM, interaction p-value = 0.016. Furthermore, statistically significant differences in the effect of HCTR versus UC between DM and non-DM were observed in ventilation at rest: - 0.34 l/min [95% CI - 1.60, 0.91 l/min] in DM and 0.83 l/min [95% CI - 0.06, 1.73 l/min] in non-DM, interaction p value = 0.0496 and in VE/VCO₂ slope: 1.52 [95% CI - 1.55, 4.59] for DM vs. - 1.44 [95% CI - 3.64, 0.77] for non-DM, interaction p value = 0.044.

Conclusions: The benefits of hybrid comprehensive telerehabilitation versus usual care on the improvement of physical performance, ventilatory profile and gas exchange parameters were more pronounced in patients with HFrEF without DM as compared to patients with DM.

Trial registration: ClinicalTrials.gov Identifier: NCT02523560. Registered 3rd August 2015. https://clinicaltrials.gov/ct2/show/NCT02523560?term=NCT02523560&draw=2&rank=1 . Other Study ID Numbers: STRATEGME1/233547/13/NCBR/2015.

Keywords: Diabetes mellitus; Exercise training; Heart failure; Hybrid rehabilitation; Telerehabilitation.

Fig. 1

Study design. HCTR-DM patients in hybrid comprehensive telerehabilitation arm with heart failure and diabetes, HCTR-nonDM patients in hybrid comprehensive telerehabilitation arm with heart failure and without diabetes, HFrEF heart failure with reduced ejection fraction, UC-DM patients in usual care arm with heart failure and diabetes, UC-nonDM patients in usual care arm with heart failure and without diabetes

Fig. 2

Forest plots of changes in parameters of main cardiopulmonary capacity in patients with and without diabetes. delta alteration in CPET parameters between baseline and 9-week based on formula: HCTR-UC for DM minus HCTR-UC for non-DM, DM patients with diabetes, nonDM patients without diabetes, VO₂ peak peak oxygen uptake, VAT ventilatory anaerobic threshold, VE/VCO₂ slope slope of ventilatory equivalent for carbon dioxide