Effects of Sacred Dances versus Conventional Physical Training on Functional Capacity and Quality of Life in Women with Heart Failure: Protocol for a Randomized Active-Controlled Crossover Non-Inferiority Trial (RED-WHF)

This protocol describes the RED-WHF trial, a randomized, active-controlled, two-period crossover clinical trial designed to evaluate whether Sacred Dances (SD)—as a mind-body intervention—are non-inferior to conventional physical training (PT) regarding functional capacity and quality of life in women with heart failure (HF). Sedentary behavior and emotional stress significantly worsen HF prognosis, yet conventional exercise programs face barriers in patient adherence and variable motivation. Sacred Dances, a form of low-to-moderate-intensity moving meditation, may enhance physical fitness while promoting emotional well-being and spiritual connection (flourishing). We will recruit 30 sedentary women aged 18 to 70 with stable HF (NYHA class I-III) and a documented left ventricular ejection fraction. Participants will be randomized 1:1 to one of two treatment sequences: SD followed by PT, or vice versa. Each 12-week intervention phase consists of two weekly sessions, lasting 90 minutes for SD (with 60 minutes of active dancing to allow choreography instruction) and 60 minutes for PT, separated by a 3-week washout period. Primary outcomes are functional capacity (6-minute walk test [6MWT]) and health-related quality of life (EQ-5D-5L Index and VAS). Secondary outcomes include adherence rates, spiritual attitudes (ARES scale), symptoms of depression, anxiety, and stress (DASS-21), and perceived subjective impact (EUPI-12). Statistical planning incorporates linear mixed models (LMM) with treatment, period, and sequence fixed effects, and an intention-to-treat approach with multiple imputation for missing data. To establish non-inferiority, a 30-meter margin for the 6MWT difference will be applied. The study was approved by the local Ethics Committee (CEP/EBMSP opinion 7.443.180, CAAE: 86133125.0.0000.5544) and prospectively registered in the Brazilian Registry of Clinical Trials (ReBEC ID: RBR-85tkdz5).