{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,27]],"date-time":"2026-02-27T05:11:18Z","timestamp":1772169078190,"version":"3.50.1"},"reference-count":41,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2022,8,12]],"date-time":"2022-08-12T00:00:00Z","timestamp":1660262400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100009053","name":"The Wellcome Trust DBT India Alliance","doi-asserted-by":"publisher","award":["IA\/CPHS\/20\/1\/505229"],"award-info":[{"award-number":["IA\/CPHS\/20\/1\/505229"]}],"id":[{"id":"10.13039\/501100009053","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100001411","name":"Indian Council of Medical Research","doi-asserted-by":"publisher","award":["55\/4\/5\/CARE-HF\/2018-NCD-II"],"award-info":[{"award-number":["55\/4\/5\/CARE-HF\/2018-NCD-II"]}],"id":[{"id":"10.13039\/501100001411","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["wellcomeopenresearch.org"],"crossmark-restriction":false},"short-container-title":["Wellcome Open Res"],"abstract":"<ns4:p>\n                    <ns4:bold>Background:<\/ns4:bold>\n                    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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Methods:<\/ns4:bold>\n                    We will conduct a 2\n                    <ns4:bold\/>\n                    \u00d7 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 \u2018days alive and out of hospital\u2019, 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.\u00a0 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.\n                  <\/ns4:p>\n                  <ns4:p>\n                    <ns4:bold>Discussion:<\/ns4:bold>\n                    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.\n                  <\/ns4:p>","DOI":"10.12688\/wellcomeopenres.18047.1","type":"journal-article","created":{"date-parts":[[2022,8,12]],"date-time":"2022-08-12T05:05:20Z","timestamp":1660280720000},"page":"210","update-policy":"https:\/\/doi.org\/10.12688\/wellcomeopenres.crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["A multicentric, 2 \u00d7 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"],"prefix":"10.12688","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4172-4307","authenticated-orcid":false,"given":"Panniyammakal","family":"Jeemon","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Salim","family":"Reethu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sanjay","family":"Ganapathi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lakshmipuram Rajappan","family":"Lakshmi 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Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC.","volume":"33","author":"J McMurray","year":"2012","journal-title":"Eur J Heart Fail."},{"key":"ref-3","first-page":"283-8","article-title":"Heart failure: epidemiology and prevention in India.","volume":"23","author":"M Huffman","year":"2010","journal-title":"Natl Med J India."},{"key":"ref-4","doi-asserted-by":"publisher","first-page":"585-94","DOI":"10.1007\/s10389-019-01141-w","article-title":"Financial burden of heart failure in a developing country: cost analysis from Manipal Heart Failure Registry, India.","volume":"29","author":"A Singh","year":"2021","journal-title":"J Public Health."},{"key":"ref-5","doi-asserted-by":"publisher","first-page":"139-43","DOI":"10.1016\/j.ijcard.2020.10.012","article-title":"Five-year mortality and readmission rates in patients with heart failure in India: Results from the Trivandrum heart failure registry.","volume":"326","author":"S Harikrishnan","year":"2021","journal-title":"Int J Cardiol."},{"key":"ref-6","doi-asserted-by":"publisher","first-page":"40-6","DOI":"10.1016\/j.hrtlng.2017.09.004","article-title":"Patterns of self-care and clinical events in a cohort of adults with heart failure: 1 year follow-up.","volume":"47","author":"C Lee","year":"2018","journal-title":"Heart Lung."},{"key":"ref-7","doi-asserted-by":"publisher","first-page":"676-82","DOI":"10.1111\/jan.13903","article-title":"Self-care interventions for adults with heart failure: A systematic review and meta-analysis protocol.","volume":"75","author":"T Ruppar","year":"2019","journal-title":"J Adv Nurs."},{"key":"ref-8","doi-asserted-by":"publisher","first-page":"1179546819856855","DOI":"10.1177\/1179546819856855","article-title":"Self-Care Interventions That Reduce Hospital Readmissions in Patients With Heart Failure; Towards the Identification of Change Agents.","volume":"13","author":"S Toukhsati","year":"2019","journal-title":"Clin Med 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rehabilitation\/secondary prevention programs: 2007 update: a scientific statement from the American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee, the Council on Clinical Cardiology; the Councils on Cardiovascular Nursing, Epidemiology and Prevention, and Nutrition, Physical Activity, and Metabolism; and the American Association of Cardiovascular and Pulmonary Rehabilitation.","volume":"115","author":"G Balady","year":"2007","journal-title":"Circulation."},{"key":"ref-13","doi-asserted-by":"publisher","first-page":"323-9","DOI":"10.1016\/j.ijcard.2004.10.021","article-title":"Effect of physical training on quality of life and oxygen consumption in patients with congestive heart failure.","volume":"103","author":"M Klocek","year":"2005","journal-title":"Int J Cardiol."},{"key":"ref-14","doi-asserted-by":"publisher","first-page":"99-103","DOI":"10.4103\/1995-705X.95064","article-title":"Effects of Combined Early In-Patient Cardiac Rehabilitation and Structured Home-based Program on Function among Patients with Congestive Heart Failure: A Randomized Controlled Trial.","volume":"12","author":"A Babu","year":"2011","journal-title":"Heart Views."},{"key":"ref-15","doi-asserted-by":"publisher","first-page":"257-62","DOI":"10.1176\/appi.psychotherapy.2000.54.2.257","article-title":"Cognitive behavioral therapy of depression: theory, treatment, and empirical status.","volume":"54","author":"L McGinn","year":"2000","journal-title":"Am J Psychother."},{"key":"ref-16","doi-asserted-by":"publisher","first-page":"799-806","DOI":"10.1016\/j.amjmed.2007.03.026","article-title":"Impact of cardiac rehabilitation on depression and its associated mortality.","volume":"120","author":"R Milani","year":"2007","journal-title":"Am J Med."},{"key":"ref-17","article-title":"CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised 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patients","author":"S Harikrishnan","year":"2022"},{"key":"ref-22","doi-asserted-by":"publisher","first-page":"g1687","DOI":"10.1136\/bmj.g1687","article-title":"Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide.","volume":"348","author":"T Hoffmann","year":"2014","journal-title":"BMJ."},{"key":"ref-23","doi-asserted-by":"publisher","first-page":"97-101","DOI":"10.1136\/bmjebm-2019-111249","article-title":"TIDieR checklist evaluation of clinical trial intervention reporting for recent FDA-approved anticancer medications.","volume":"25","author":"C Wayant","year":"2020","journal-title":"BMJ Evid Based Med."},{"key":"ref-24","article-title":"A multicentric, 2 x 2 factorial, randomised, open-label trial to evaluate the clinical effectiveness of structured physical activity training and behavioural therapy versus usual care in heart failure patients: a protocol for the PACT-HF trial","author":"S Harikrishnan","year":"2022"},{"key":"ref-25","article-title":"Exercise Schedule","author":"S Harikrishnan","year":"2022"},{"key":"ref-26","article-title":"CBT_Participant_English.pdf","year":"2000"},{"key":"ref-27","article-title":"Behavior therapy","author":"S Harikrishnan","year":"2022"},{"key":"ref-28","article-title":"Schedule for evaluation","author":"S Harikrishnan","year":"2022"},{"key":"ref-29","doi-asserted-by":"publisher","first-page":"606-13","DOI":"10.1046\/j.1525-1497.2001.016009606.x","article-title":"The PHQ-9: validity of a brief depression severity measure.","volume":"16","author":"K Kroenke","year":"2001","journal-title":"J Gen Intern Med."},{"key":"ref-30","doi-asserted-by":"publisher","first-page":"1092-7","DOI":"10.1001\/archinte.166.10.1092","article-title":"A brief measure for assessing generalized anxiety disorder: the GAD-7.","volume":"166","author":"R Spitzer","year":"2006","journal-title":"Arch Intern Med."},{"key":"ref-31","doi-asserted-by":"publisher","first-page":"996-1001","DOI":"10.1016\/j.jval.2016.07.001","article-title":"Psychometric Properties of the Four-Item Morisky Green Levine Medication Adherence Scale among Atherosclerosis Risk in Communities (ARIC) Study Participants.","volume":"19","author":"H Beyhaghi","year":"2016","journal-title":"Value Health."},{"key":"ref-32","doi-asserted-by":"publisher","first-page":"e019413","DOI":"10.1136\/bmjopen-2017-019413","article-title":"Development and validation of the Multimorbidity Treatment Burden Questionnaire (MTBQ).","volume":"8","author":"P Duncan","year":"2018","journal-title":"BMJ Open."},{"key":"ref-33","doi-asserted-by":"publisher","first-page":"1245-55","DOI":"10.1016\/s0735-1097(00)00531-3","article-title":"Development and evaluation of the Kansas City Cardiomyopathy Questionnaire: a new health status measure for heart failure.","volume":"35","author":"C Green","year":"2000","journal-title":"J Am Coll Cardiol."},{"key":"ref-34","doi-asserted-by":"publisher","first-page":"1727-36","DOI":"10.1007\/s11136-011-9903-x","article-title":"Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L).","volume":"20","author":"M Herdman","year":"2011","journal-title":"Qual Life Res."},{"key":"ref-35","doi-asserted-by":"publisher","first-page":"1753944719870084","DOI":"10.1177\/1753944719870084","article-title":"6-minute walking test: a useful tool in the management of heart failure patients.","volume":"13","author":"S Giannitsi","year":"2019","journal-title":"Ther Adv Cardiovasc Dis."},{"key":"ref-36","doi-asserted-by":"publisher","first-page":"111-7","DOI":"10.1164\/ajrccm.166.1.at1102","article-title":"ATS statement: guidelines for the six-minute walk test.","volume":"166","year":"2002","journal-title":"Am J Respir Crit Care Med."},{"key":"ref-37","doi-asserted-by":"publisher","first-page":"553-565","DOI":"10.1016\/j.apmr.2019.10.183","article-title":"Measurement Properties of the Hand Grip Strength Assessment: A Systematic Review With Meta-analysis.","volume":"101","author":"P Bobos","year":"2020","journal-title":"Arch Phys Med Rehabil."},{"key":"ref-38","doi-asserted-by":"publisher","first-page":"1-4","DOI":"10.15761\/TiM.1000144","article-title":"Handgrip strength and functional class as prognostic factors in elderly patients with heart failure in Colombia. FORCE II study.","volume":"18","author":"A Amar\u00eds-Vergara","year":"2018","journal-title":"Trends Med."},{"key":"ref-39","doi-asserted-by":"publisher","first-page":"842-848","DOI":"10.1016\/j.cardfail.2018.05.007","article-title":"In-Hospital and Three-Year Outcomes of Heart Failure Patients in South India: The Trivandrum Heart Failure Registry.","volume":"24","author":"G Sanjay","year":"2018","journal-title":"J Card Fail."},{"key":"ref-40","first-page":"353-9","article-title":"Cardiac Rehabilitation in Patients with Heart Failure.","volume":"30","author":"T Fu","year":"2014","journal-title":"Acta Cardiol Sin."},{"key":"ref-41","doi-asserted-by":"publisher","first-page":"691-705","DOI":"10.1016\/j.jchf.2019.04.023","article-title":"Exercise-Based Rehabilitation for Heart Failure: Cochrane Systematic Review, Meta-Analysis, and Trial Sequential Analysis.","volume":"7","author":"R Taylor","year":"2019","journal-title":"JACC: Heart Failure."}],"container-title":["Wellcome Open Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/7-210\/v1\/xml","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/7-210\/v1\/pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/7-210\/v1\/iparadigms","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,5]],"date-time":"2022-09-05T10:25:12Z","timestamp":1662373512000},"score":1,"resource":{"primary":{"URL":"https:\/\/wellcomeopenresearch.org\/articles\/7-210\/v1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8,12]]},"references-count":41,"URL":"https:\/\/doi.org\/10.12688\/wellcomeopenres.18047.1","relation":{"has-review":[{"id-type":"doi","id":"10.21956\/wellcomeopenres.20013.r52034","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.20013.r52033","asserted-by":"subject"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.20013.r52033","asserted-by":"object"},{"id-type":"doi","id":"10.21956\/wellcomeopenres.20013.r52034","asserted-by":"object"}]},"ISSN":["2398-502X"],"issn-type":[{"value":"2398-502X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,8,12]]},"assertion":[{"value":"Indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/7-210\/v1#article-reports","order":0,"name":"referee-status","label":"Referee status","group":{"name":"current-referee-status","label":"Current Referee Status"}},{"value":"10.21956\/wellcomeopenres.20013.r52033, Veena Nanjappa, Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Mysore, Karnataka, India, 19 Aug 2022, version 1, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/7-210\/v1#referee-response-52033","order":0,"name":"referee-response-52033","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.21956\/wellcomeopenres.20013.r52034, Roopa Shivashankar, Indian Council of Medical Research (ICMR), New Delhi, Delhi, India, 05 Sep 2022, version 1, indexed","URL":"https:\/\/wellcomeopenresearch.org\/articles\/7-210\/v1#referee-response-52034","order":1,"name":"referee-response-52034","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"This work was supported by the Indian Council of medical research (ICMR), New Delhi, India, towards Centre for Advanced Research and Excellence (CARE) in Heart Failure, File No. 55\/4\/5\/CARE-HF\/2018-NCD-II. Panniyammakal Jeemon is supported by the Wellcome\nTrust\/DBT India Alliance Senior Fellowship [IA\/CPHS\/20\/1\/505229]. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.","order":2,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}