Handgrip strength and functional class as prognostic factors in elderly patients with heart failure in Colombia. FORCE II study

Amarís-Vergara, Amaury Alexis; Ariza, Gustavo Alejandro Palomino; Rodríguez-Hernández, Betsy Viviana; Velandia-Carrillo, Carlos; Sanabria, Miguel Oswaldo Cadena; Ochoa, Miguel

doi:10.15761/tim.1000144

Cited by 1 publication

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“…Care will be taken to avoid Valsalva manoeuvres during this time. The average of the three attempts with a resting period of 15 seconds between attempts will be performed and the best value among them will also be recorded during the procedure 38 .…”

Section: Methodsmentioning

confidence: 99%

A multicentric, 2 × 2 factorial, randomised, open-label trial to evaluate the clinical effectiveness of structured physical activity training and cognitive behavioural therapy versus usual care in heart failure patients: a protocol for the PACT-HF trial

Jeemon¹,

Reethu²,

Ganapathi³

et al. 2022

Wellcome Open Res

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Background: Heart failure (HF) is a multi-morbid chronic condition, which adversely affects the quality of life of the affected individual. Engaging the patient and their caregivers in self-care is known to reduce mortality, rehospitalisation and improve quality of life among HF patients. The PACT-HF trial will answer whether clinical benefits in terms of mortality and hospitalisation outcomes can be demonstrated by using a pragmatic design to explore the specific effects of physical activity, and cognitive behavioural therapy in HF patients in India. Methods: We will conduct a 2 × 2 factorial, randomized, open-label trial, which aims to see if rehabilitation strategies of structured physical activity training and cognitive behavioural therapy for depression and self-management reduce the risk of repeat hospitalisation and deaths in HF patients in India. Patients will be randomised to (1) physical activity + usual care (2) cognitive behaviour therapy + usual care, (3) physical activity + cognitive behaviour therapy + usual care, and (4) usual care at 1:1:1:1 ratio. Time to mortality will be the primary outcome. A composite of mortality and hospitalisation for HF will be the main secondary outcome. Additional secondary outcomes will include ‘days alive and out of hospital’, cumulative hospitalisation, quality of life, Minnesota Living with Heart Failure questionnaire score, depression score, six minutes walking distance, handgrip strength, and adherence to medicines and lifestyle. The effects of intervention on the primary outcome will be estimated from Cox proportional hazard models. For the continuous secondary outcome variables, differences between randomised groups will be estimated from linear mixed models or generalised estimating equations (GEE) as appropriate. Discussion: PACT-HF is designed to provide reliable evidence about the balance of benefits and risks conferred by physical activity and cognitive behavioural therapy-based cardiac rehabilitation for those with HF, irrespective of their initial disease severity.

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Section: Methodsmentioning

confidence: 99%