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

Wellcome Open Research

article

Panniyammakal Jeemon¹  Salim Reethu²  Sanjay Ganapathi²  Lakshmipuram Rajappan Lakshmi Kanth²  Eapen Punnoose³  Jabir Abdullakutty⁴  Shafeeq Mattumal⁵  Johny Joseph⁶  Stigi Joseph⁷  Chitra Venkateswaran⁸  Poornima Sunder⁹  Abraham Samuel Babu^1,10  Sebastian Padickaparambil^1,11  Kandagathuparambil Rajan Neenumol²  Susanna Chacko²  Shamla Shajahan²  Krishnaja Krishnankutty³  Selma Devis⁷  Rani Joseph⁶  Bhagavathikandy Shemija⁵  Sneha Anna John⁴  Sivadasanpillai Harikrishnan² 

[1] ICMR-Centre for Advanced Research and Excellence in Heart Failure ,(CARE-HF) and Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology;ICMR-Centre for Advanced Research and Excellence in Heart Failure ,(CARE-HF), Sree Chitra Thirunal Institute of Medical Sciences and Technology;MOSC Medical College Hospital;Lisie Hospital;Aster MIMS;Caritas Hospital;Little flower hospital and research centre;Believers Church Medical College Hospital;Mehac Foundation;Department of Physiotherapy, Manipal College of Health Professions;Department of Clinical Psychology, Manipal College of Health Professions

关键词: Factorial trial;    heart failure;    cardiac rehabilitation;    exercise;    behaviour therapy;    India;   

DOI  :  10.12688/wellcomeopenres.18047.1

学科分类：内科医学

来源: Wellcome

【 摘 要 】

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.

【 授权许可】

CC BY