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Hospital-based and telemonitoring guided home-based training programs: effects on exercise tolerance and quality of life in patients with heart failure (NYHA class III) and cardiac resynchronization therapy. A randomized, prospective observation
Smolis-Bak E, Dabrowski R, Piotrowicz E, Chwyczko T, Dobraszkiewicz-Wasilewska B, Kowalik I, Kazimierska B, Jedrzejczyk B, Smolis R, Gepner K, Maciag A, Sterlinski M, Szwed H
International Journal of Cardiology 2015 Nov 15;199:442-447
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

Cardiac resynchronization therapy with defibrillator function (CRT-D) along with an optimal medical therapy improves symptoms, cardiac efficiency, quality of life (QoL) and prognosis in patients with heart failure (CHF). The aim of the study was to assess effects of hospital-based and home-based/telemonitoring exercise training. METHODS: The prospective, randomized study was conducted in 52 patients (pts), aged 45 to 75 years (mean 62 +/- 9.3), with CHF of ischemic or another etiology, NYHA class III and implanted CRT-D. Group CRT-Ex (n = 26) underwent initial exercise training in the hospital setting and continued training program at home with telemonitoring 5 times a week for 8 weeks. The CRT-control group (n = 26) consisted of patients who had hospital rehabilitation, but no training program after discharge. RESULTS: No differences between the groups in CHF etiology, comorbidities, medical therapy and in any of spiroergometry (CPX) parameters at baseline were observed. After 3 to 4 months the CRT-Ex group achieved better results in VO2peak, VCO2 peak and treadmill test duration. But after 12 months the measurements returned to the baseline values. No significant differences were observed directly between two groups in distances of 6-MWT at baseline, at 3 to 4 months and at 12 months. Echocardiographic evaluation showed significant reduction of left ventricular dimensions and improvement in the left ventricular ejection fraction (EF), in both groups (25.3 +/- 7.4% to 28.9 +/- 9.1%, CRT-Ex group, p = 0.0213 and 24.9 +/- 7.2% to 31.7 +/- 10.6%, CRT-control group, p = 0.0001). Significant improvement in all domains of QoL was observed in the CRT-Ex group, while the CRT-control pts declared only higher energy levels and less pain. Intensity of telemonitoring guided home-based exercise training was low. In the 12- and 18-months follow-up there were no differences in the ICD-interventions, mortality or hospitalization rates between the groups. CONCLUSIONS: A structured exercise training program in the hospital and home-based with telemonitoring was safe option of additional treatment and improved directly physical fitness and, quality of life in patients with NYHA III CHF and CRT-D. However these effects haven't been sustained in longer period of time and had no impact on prognosis.

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