Remote maintenance cardiac rehabilitation (MAINTAIN): A protocol for a randomised feasibility study

Background Long-term adherence to exercise is often poor for people with coronary heart disease (CHD) who have completed supervised, centre-based cardiac rehabilitation. The aim of this study is to assess the feasibility of a remotely prescribed, delivered and monitored cardiac rehabilitation intervention using a wearable device to support long-term adherence to exercise and physical activity during maintenance of cardiac rehabilitation. Methods After completing cardiac rehabilitation, 30 participants with CHD, will be randomised (1:1) to an intervention (n = 15) or a usual care group (n = 15) in a 12-month feasibility randomised controlled trial (RCT). The intervention will comprise of an exercise consultation, personalised exercise prescription delivered via a wearable activity monitor using biometric feedback, regular monitoring via check-ins, and feedback text-messages for 6-months. Participants will be assessed at baseline (following completion of cardiac rehabilitation) and at three-, six-, and 12-months post-randomisation. The primary outcome will be feasibility, including assessment of eligibility, recruitment, adherence, and acceptability. Secondary outcomes will include exercise capacity, physical activity behaviours, cardiovascular disease risk and quality of life. Semi-structured interviews will be conducted at three-, six-, and 12-months post-randomisation (and with those who drop-out) to explore the acceptability of the study intervention and procedures. A questionnaire will be offered to those who decline participation. Discussion The MAINTAIN study will evaluate the feasibility of conducting a future definitive multi-centre RCT testing a remotely prescribed and monitored long-term mHealth maintenance exercise programme, versus usual care, for people with CHD who have completed cardiac rehabilitation. Trial registration number ClinicalTrials.gov, NCT05292287. Registered on 22/03/2022

[1]  D. Panagiotakos,et al.  Effectiveness of Home-Based Cardiac Rehabilitation, Using Wearable Sensors, as a Multicomponent, Cutting-Edge Intervention: A Systematic Review and Meta-Analysis , 2022, Journal of clinical medicine.

[2]  G. Pepera,et al.  Safety of home-based cardiac rehabilitation: A systematic review. , 2022, Heart & lung : the journal of critical care.

[3]  G. Pepera,et al.  Epidemiology, risk factors and prognosis of cardiovascular disease in the Coronavirus Disease 2019 (COVID-19) pandemic era: a systematic review. , 2022, Reviews in cardiovascular medicine.

[4]  D. Broom,et al.  Is It Really Home-Based? A Commentary on the Necessity for Accurate Definitions across Exercise and Physical Activity Programmes , 2021, International journal of environmental research and public health.

[5]  K. George,et al.  Charter to establish clinical exercise physiology as a recognised allied health profession in the UK: a call to action , 2021, BMJ Open Sport & Exercise Medicine.

[6]  P. Brubaker,et al.  How has technology been used to deliver cardiac rehabilitation during the COVID-19 pandemic? An international cross-sectional survey of healthcare professionals conducted by the BACPR , 2021, BMJ Open.

[7]  M. Tully,et al.  Changes in physical activity and sedentary behaviours from before to during the COVID-19 pandemic lockdown: a systematic review , 2021, BMJ Open Sport & Exercise Medicine.

[8]  Paul Dendale,et al.  Digital Health in Cardiac Rehabilitation and Secondary Prevention: A Search for the Ideal Tool , 2020, Sensors.

[9]  D. Ding,et al.  Do smartphone applications and activity trackers increase physical activity in adults? Systematic review, meta-analysis and metaregression , 2020, British Journal of Sports Medicine.

[10]  M. Wilhelm,et al.  Effectiveness of Home-Based Mobile Guided Cardiac Rehabilitation as Alternative Strategy for Nonparticipation in Clinic-Based Cardiac Rehabilitation Among Elderly Patients in Europe , 2020, JAMA cardiology.

[11]  O. Fersia,et al.  The impact of the COVID-19 pandemic on cardiology services , 2020, Open Heart.

[12]  P. Doherty,et al.  Standardization and quality improvement of secondary prevention through cardiovascular rehabilitation programmes in Europe: The avenue towards EAPC accreditation programme: A position statement of the Secondary Prevention and Rehabilitation Section of the European Association of Preventive Cardiolog , 2020, European journal of preventive cardiology.

[13]  M. Underwood,et al.  Does contemporary exercise-based cardiac rehabilitation improve quality of life for people with coronary artery disease? A systematic review and meta-analysis , 2020, BMJ Open.

[14]  M. Pakosh,et al.  Systematic review of cardiac rehabilitation guidelines: Quality and scope , 2020, European journal of preventive cardiology.

[15]  F. Solmi,et al.  Can consumer wearable activity tracker-based interventions improve physical activity and cardiometabolic health in patients with chronic diseases? A systematic review and meta-analysis of randomised controlled trials , 2020, International Journal of Behavioral Nutrition and Physical Activity.

[16]  A. Bergland,et al.  Long-term follow-up with a smartphone application improves exercise capacity post cardiac rehabilitation: A randomized controlled trial , 2020, European journal of preventive cardiology.

[17]  F. Hettinga,et al.  The Role of Technology in Adherence to Physical Activity Programs in Patients with Chronic Diseases Experiencing Fatigue: a Systematic Review , 2019, Sports Medicine - Open.

[18]  J. Coombes,et al.  Impact of wearable physical activity monitoring devices with exercise prescription or advice in the maintenance phase of cardiac rehabilitation: systematic review and meta-analysis , 2019, BMC Sports Science, Medicine and Rehabilitation.

[19]  Daniel E Forman,et al.  Home-Based Cardiac Rehabilitation: A Scientific Statement From the American Association of Cardiovascular and Pulmonary Rehabilitation, the American Heart Association, and the American College of Cardiology. , 2019, Circulation.

[20]  Jennifer Dixon,et al.  The NHS long term plan , 2019, British Medical Journal.

[21]  P. Ritvo,et al.  Wearable Technology and Physical Activity Behavior Change in Adults With Chronic Cardiometabolic Disease: A Systematic Review and Meta-Analysis , 2018, American journal of health promotion : AJHP.

[22]  Nader N Kabboul,et al.  Comparative Effectiveness of the Core Components of Cardiac Rehabilitation on Mortality and Morbidity: A Systematic Review and Network Meta-Analysis , 2018, Journal of clinical medicine.

[23]  W. Kraus,et al.  Effects of a 12‐week mHealth program on peak VO2 and physical activity patterns after completing cardiac rehabilitation: A randomized controlled trial , 2018, American heart journal.

[24]  P. Tugwell,et al.  CONSORT 2010 statement: extension to randomised pilot and feasibility trials , 2016, British Medical Journal.

[25]  Michael J.A. Williams,et al.  Examining motivations and barriers for attending maintenance community-based cardiac rehabilitation using the health-belief model. , 2015, Heart, lung & circulation.

[26]  Eivind Aadland,et al.  Reliability of the Actigraph GT3X+ Accelerometer in Adults under Free-Living Conditions , 2015, PloS one.

[27]  Minsoo Kang,et al.  Validation of the ActiGraph GT3X and activPAL Accelerometers for the Assessment of Sedentary Behavior , 2015 .

[28]  Steven A Julious,et al.  Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable , 2015, Statistical methods in medical research.

[29]  S. Hagen,et al.  A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse , 2013, Trials.

[30]  N. Cook,et al.  Development and validation of a prediction rule for recurrent vascular events based on a cohort study of patients with arterial disease: the SMART risk score , 2013, Heart.

[31]  D. Rennie,et al.  SPIRIT 2013 statement: defining standard protocol items for clinical trials. , 2013, Annals of internal medicine.

[32]  S. Michie,et al.  The behaviour change wheel: A new method for characterising and designing behaviour change interventions , 2011, Implementation science : IS.

[33]  G. Bonsel,et al.  Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) , 2011, Quality of Life Research.

[34]  P. van der Veer,et al.  Spirit , 2011, American Afterlives.

[35]  D. Moher,et al.  CorrespondenceCONSORT 2010 Statement : updated guidelines for reporting parallel group randomised trials , 2010 .

[36]  Edgar Erdfelder,et al.  G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences , 2007, Behavior research methods.

[37]  B. Löwe,et al.  A brief measure for assessing generalized anxiety disorder: the GAD-7. , 2006, Archives of internal medicine.

[38]  V. Braun,et al.  Using thematic analysis in psychology , 2006 .

[39]  J. Hibbard,et al.  Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. , 2004, Health services research.

[40]  A. Cohen-Solal,et al.  Physical activity for primary and secondary prevention. Position paper of the Working Group on Cardiac Rehabilitation and Exercise Physiology of the European Society of Cardiology , 2003, European journal of cardiovascular prevention and rehabilitation : official journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology.

[41]  B. Bock,et al.  Program Participation and Physical Activity Maintenance after Cardiac Rehabilitation , 2003, Behavior modification.

[42]  M. Rayner,et al.  The economic burden of coronary heart disease in the UK , 2002, Heart.

[43]  R. Spitzer,et al.  The PHQ-9 , 2001, Journal of General Internal Medicine.

[44]  R. Spitzer,et al.  Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. , 1999, JAMA.

[45]  R. H. Browne On the use of a pilot sample for sample size determination. , 1995, Statistics in medicine.

[46]  P. Thompson,et al.  ACSM's Guidelines for Exercise Testing and Prescription , 1995 .

[47]  M. S. Singh,et al.  Development of a shuttle walking test of disability in patients with chronic airways obstruction. , 1992, Thorax.

[48]  G. Guyatt,et al.  Effects on quality of life with comprehensive rehabilitation after acute myocardial infarction. , 1991, The American journal of cardiology.

[49]  R. Shephard,et al.  A simple method to assess exercise behavior in the community. , 1969, Canadian journal of applied sport sciences. Journal canadien des sciences appliquees au sport.

[50]  Sei J. Lee,et al.  Mobile Health Intervention Promoting Physical Activity in Adults Post Cardiac Rehabilitation: Pilot Randomized Controlled Trial , 2020, JMIR formative research.

[51]  Shirley M Moore,et al.  Women's and men's exercise adherence after a cardiac event. , 2010, Research in gerontological nursing.

[52]  D. Moher,et al.  CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials , 2010, Trials.

[53]  Tiffany Moxham,et al.  Home-based versus centre-based cardiac rehabilitation. , 2010, The Cochrane database of systematic reviews.

[54]  R. Spitzer,et al.  The PHQ-9: validity of a brief depression severity measure. , 2001, Journal of general internal medicine.

[55]  M. Johnston,et al.  Measures in Health Psychology: A User's Portfolio , 1995 .

[56]  BHF Fundraising,et al.  The British Heart Foundation , 1963, Nature.

[57]  M. Wilhelm,et al.  Effectiveness of Home-Based Mobile Guided Cardiac Rehabilitation as Alternative Strategy for Nonparticipation in Clinic-Based Cardiac Rehabilitation Among Elderly Patients in Europe A Randomized Clinical Trial , 2022 .