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A relaxation response randomized trial on patients with chronic heart failure
Chang BH, Hendricks A, Zhao Y, Rothendler JA, loCastro JS, Slawsky MT
Journal of Cardiopulmonary Rehabilitation 2005 May-Jun;25(3):149-157
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

PURPOSE: Patients with various medical conditions benefit from eliciting the relaxation response (RR), using a variety of techniques, but few studies have focused on chronic heart failure (CHF). We evaluated the efficacy of an RR intervention program on the quality of life (QOL) and exercise capacity of CHF patients by conducting a single-blind, 3-arm, randomized, controlled trial. METHODS: Between April 2000 and June 2002, we enrolled 95 patients with moderate severity CHF from the Veterans Affairs Boston Healthcare System. Patients in the study intervention group attended a weekly RR group for 15 weeks and were requested to practice the techniques at home twice a day. A 15-week cardiac education (EDU) program was used as an alternative intervention, and usual care (UC) was the control group. The QOL questionnaires and a bicycle test were administered at baseline and after intervention or 15 to 19 weeks. RESULTS: Eighty-three (87%) of the 95 enrolled patients completed both baseline and post-intervention QOL measures (31 RR, 24 EDU, and 28 UC). No dropout bias was observed. The RR group had significantly better QOL change scores in peace-spiritual scales than did the UC group (p = 0.02), adjusting for baseline scores, time between assessments, age, education, diet, and medication, whereas no significant difference was observed between the EDU and UC groups. A similar trend was observed in emotional QOL (RR and UC group comparison, p = 0.07). No statistically significant intervention effect on physical QOL or exercise capacity was observed. CONCLUSIONS: A short RR intervention can improve some aspects of QOL in CHF patients.
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