Key result
The Technology-based Comprehensive Cardiac Rehabilitation Therapy (TaCT) intervention will be evaluated for its effect on functional capacity compared to usual care in 100 women with cardiovascular disease.
Why the study?
Does the TaCT electronic cardiac rehabilitation intervention improve functional capacity in adult women with cardiovascular disease?
RCT (n=100)
Single-blind
Permuted block (size 10) randomization (1:1 SNOSE)
No
Does the TaCT electronic cardiac rehabilitation intervention improve functional capacity in adult women with cardiovascular disease?
This protocol outlines a randomized controlled trial to evaluate the effectiveness of a women-focused electronic cardiac rehabilitation intervention on functional capacity in a middle-income setting.
Women are underrepresented in cardiac rehabilitation (CR) despite the benefits, and this is exacerbated in lower-resource settings where CR is insufficiently available. In this randomized controlled trial, the effectiveness of the Technology-based Comprehensive Cardiac Rehabilitation Therapy (TaCT) electronic cardiac rehabilitation (eCR) intervention on functional capacity, risk factors, quality of life, heart-health behaviors, symptoms, and morbidity will be tested among women with CVD in a middle-income country. Following a pilot study, a single-center, single-blinded, 2 parallel-arm (1:1 SNOSE) superiority trial comparing an eCR intervention (TaCT) to usual care, with assessments pre-intervention and at 3 and 6 months will be undertaken. One hundred adult women will be recruited. Permuted block (size 10) randomization will be applied. The 6-month intervention comprises an app, website, SMS texts with generic heart-health management advice, and bi-weekly 1:1 telephone calls with a nurse trainee. Individualized exercise prescriptions will be developed based on an Incremental Shuttle Walk Test (primary outcome) and dietary plans based on 24 h dietary recall. A yoga/relaxation video will be provided via WhatsApp, along with tobacco cessation support and a moderated group chat. At 3 months, intervention engagement and acceptability will be assessed. Analyses will be conducted based on intent-to-treat. If results of this novel trial of women-focused eCR in a middle-income country demonstrate clinically-significant increases in functional capacity, this could represent an important development for the field considering this would be an important outcome for women and would translate to lower mortality.
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Menezes et al. (2022) conducted an RCT in Cardiovascular disease (n=100). Technology-based Comprehensive Cardiac Rehabilitation Therapy (TaCT) vs. Usual care was evaluated on Incremental Shuttle Walk Test (functional capacity). The Technology-based Comprehensive Cardiac Rehabilitation Therapy (TaCT) intervention will be evaluated for its effect on functional capacity compared to usual care in 100 women with cardiovascular disease.
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