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Ensayo clinico aleatorizado para evaluar el efecto de un programa de rehabilitacion cardiaca supervisado con ejercicio en el consumo de oxigeno, la funcion y calidad de vida de pacientes con falla cardiaca cronica (A randomised clinical trial to evaluate the effect of a supervised rehabilitation program with exercise on oxygen consumption, function, and quality of life of patients with chronic heart failure) [Spanish]
Lugo LH, Navas CM, Plata JA, Ortiz SD, Caraballo D, Henao AC, Garcia HI, Senior JM
Revista Colombiana de Cardiologia 2018 Mar-Apr;25(2):106-115
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; 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*

OBJECTIVE: To evaluate the effect of a supervised exercise program on oxygen consumption, function, and quality of life in patients with heart failure. DESIGN AND METHODS: A double-blind clinical trial, with parallel groups, conducted on patients with functional stage II to IV heart failure for more than 6 months and with an ejection fraction of < 40%. The primary outcome was the peak oxygen consumption at 8 weeks. RESULTS: A total of 23 patients were assigned to the intervention group and 26 to the control group. Of those, 5 died, 4 failed to complete all the evaluations, and 1 did not perform the cardiopulmonary exercise test. Finally, 17 patients were analysed in the intervention group and 20 in the control group. As regards the peak VO2, no statistically significant changes were observed at the end of the intervention program at 8 weeks (-13.3 +/- 3.9ml/kg/min in the intervention group compared to 14.8 +/- 4.6ml/kg/min in the control group, p = 0.31). There were no differences between the groups in the functional evaluations and the quality of life at 8 weeks or 6 months. However, the results showed an improvement in the functionality and quality of life in both groups. CONCLUSION: The use of a standard and supervised exercise program by patients with heart failure with an ejection fraction < 40% does not lead to significant changes in the peak VO2, when compared to a community program.

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