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CARE CR-Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based Cardiac Rehabilitation: a study protocol for a community-based controlled study with criterion methods.

ABSTRACT: INTRODUCTION:Cardiac rehabilitation (CR) reduces all-cause and cardiovascular mortality in patients with coronary heart disease (CHD). Much of this improvement has been attributed to the beneficial effects of structured exercise training. However, UK-based studies have not confirmed this. Improvements in survival and cardiovascular health are associated with concurrent improvements in cardiorespiratory fitness (CRF). It is therefore concerning that estimated CRF improvements resulting from UK-based CR are approximately one-third of those reported in international literature. Modest improvements in CRF suggest that UK CR exercise training programmes may require optimisation if long-term survival is to be improved. However, contemporary UK studies lack control data or use estimates of CRF change. Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based CR is a longitudinal, observational, controlled study designed to assess the short-term and long-term effect of CR on CRF, as well cardiovascular and cardiometabolic health. METHODS AND ANALYSIS:Patients will be recruited following referral to their local CR programme and will either participate in a routine, low-to-moderate intensity, 8-week (16 sessions) exercise-based CR programme or freely abstain from supervised exercise. Initial assessment will be conducted prior to exercise training, or approximately 2?weeks after referral to CR if exercise training is declined. Reassessment will coincide with completion of exercise training or 10 weeks after initial assessment for control participants. Participants will receive a final follow-up 12 months after recruitment. The primary outcome will be peak oxygen consumption determined using maximal cardiopulmonary exercise testing. Secondary outcomes will include changes in subclinical atherosclerosis (carotid intima-media thickness and plaque characteristics), body composition (dual X-ray absorptiometry) and cardiometabolic biomarkers. ETHICS AND DISSEMINATION:Ethical approval for this non-randomised controlled study has been obtained from the Humber Bridge NHS Research Ethics Committee-Yorkshire and the Humber on the 27th September 2013, (12/YH/0278). Results will be presented at national conferences and published in peer-reviewed journals.

SUBMITTER: Nichols S

PROVIDER: S-EPMC5829840 | biostudies-other | 2018 Jan

REPOSITORIES: biostudies-other

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CARE CR-Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based Cardiac Rehabilitation: a study protocol for a community-based controlled study with criterion methods.

Nichols Simon S Nation Fiona F Goodman Toni T Clark Andrew L AL Carroll Sean S Ingle Lee L

BMJ open 20180127 1

<h4>Introduction</h4>Cardiac rehabilitation (CR) reduces all-cause and cardiovascular mortality in patients with coronary heart disease (CHD). Much of this improvement has been attributed to the beneficial effects of structured exercise training. However, UK-based studies have not confirmed this. Improvements in survival and cardiovascular health are associated with concurrent improvements in cardiorespiratory fitness (CRF). It is therefore concerning that estimated CRF improvements resulting fr ...[more]

PMID: 29374670

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Project description:BackgroundRecent studies have revealed that many discharged patients with COVID-19 experience ongoing symptoms months later. Rehabilitation interventions can help address the consequences of COVID-19, including medical, physical, cognitive, and psychological problems. To our knowledge, no studies have investigated the effects of rehabilitation following discharge from hospital for patients with COVID-19.ObjectiveThe specific aims of this project are to investigate the effects of a 12-week exercise program on pulmonary fibrosis in patients recovering from COVID-19. A further aim will be to examine how Chinese herbal medicines as well as the gut microbiome and its metabolites regulate immune function and possibly autoimmune deficiency in the rehabilitation process.MethodsIn this triple-blinded, randomized, parallel-group, controlled clinical trial, we will recruit adult patients with COVID-19 who have been discharged from hospital in Hong Kong and are experiencing impaired lung function and pulmonary function. A total of 172 eligible patients will be randomized into four equal groups: (1) cardiorespiratory exercise plus Chinese herbal medicines group, (2) cardiorespiratory exercise only group, (3) Chinese herbal medicines only group, and (4) waiting list group (in which participants will receive Chinese herbal medicines after 24 weeks). These treatments will be administered for 12 weeks, with a 12-week follow-up period. Primary outcomes include dyspnea, fatigue, lung function, pulmonary function, blood oxygen levels, immune function, blood coagulation, and related blood biochemistry. Measurements will be recorded prior to initiating the above treatments and repeated at the 13th and 25th weeks of the study. The primary analysis is aimed at comparing the outcomes between groups throughout the study period with an α level of .05 (two-tailed).ResultsThe trial has been approved by the university ethics committee following the Declaration of Helsinki (approval number: REC/19-20/0504) in 2020. The trial has been recruiting patients. The data collection will be completed in 24 months, from January 1, 2021, to December 31, 2022.ConclusionsGiven that COVID-19 and its sequelae would persist in human populations, important findings from this study would provide valuable insights into the mechanisms and processes of COVID-19 rehabilitation.Trial registrationClinicalTrials.gov NCT04572360; https://clinicaltrials.gov/ct2/show/NCT04572360.International registered report identifier (irrid)PRR1-10.2196/25556.

Project description:BACKGROUND:Randomized trials confirm the benefits of exercise-based cardiac rehabilitation on cardiovascular risk factors. Whether exercise-based cardiac rehabilitation provides the same favourable effects in real-life cardiac rehabilitation settings, in the modern era of myocardial infarction treatment, is less well known. We examined the association between attending exercise-based cardiac rehabilitation and improvements in cardiovascular risk factors at one-year post myocardial infarction in patients included in the Swedish heart disease registry, SWEDEHEART. METHODS:In this retrospective registry-based cohort study, we included 19 136 patients post myocardial infarction (75% men, 62.8±8.7 years) who were registered in SWEDEHEART between 2011 and 2013. The association between attending exercise-based cardiac rehabilitation (43% participation rate) and changes in cardiovascular risk profile between baseline and one-year follow-up was assessed using multivariable regression analysis adjusting for age, comorbidities and medication. RESULTS:Attenders more often reported to have stopped smoking (men 64% vs 50%; women 64% vs 53%, p<0.001 for both, only smokers at baseline considered), be more physically active (men 3.9±2.5 vs 3.4±2.7 days/week; women 3.8±2.6 vs 3.0±2.8 days/week, p<0.001 for both) and achieved a slightly larger reduction in triglycerides (men -0.2±0.8 vs -0.1±0.9 mmol/L, p = 0.001; women -0.1±0.6 vs 0.0±0.8 mmol/L, p = 0.01) at one-year compared to non-attenders. Male attenders gained less weight (+0.0±5.7 vs +0.3±5.7 kg, p = 0.01) while female attenders achieved better lipid control (total cholesterol -1.2±1.4 vs -0.9±1.4 mmol/L, p<0.001; low-density lipoprotein -1.2±1.2 vs -0.9 ±1.2 mmol/L, p<0.001) compared to non-attenders. CONCLUSIONS:In an unselected registry cohort of patients post myocardial infarction, compared to non-attenders those attending exercise-based cardiac rehabilitation achieved significantly larger improvements in cardiovascular risk factors at one-year after the acute event.

Project description:BackgroundExercise-based cardiac rehabilitation is recognized as a core component of cardiovascular disease management and has been shown to reduce all-cause and cardiovascular mortality and reduce the risk of hospital readmission following a cardiac event. However, despite this, the uptake of and long-term adherence to cardiac rehabilitation exercise is poor. Delivering cardiac rehabilitation exercise virtually (ie, allowing patients to participate from their own homes) may be an alternative approach that could enhance uptake and increase adherence.ObjectiveThe aim of this study is to assess the feasibility of delivering a virtual cardiac rehabilitation exercise program supported by the Eastern Corridor Medical Engineering - Cardiac Rehabilitation (ECME-CR) platform.MethodsA convenience sample (n=20) of participants eligible to participate in community-based cardiac rehabilitation exercise will be recruited. Participants will be randomized to one of two study groups. Both study groups will perform the same exercise program, consisting of twice-weekly sessions of 60 minutes each, over an 8-week intervention period. Participants in the intervention group will partake in virtually delivered cardiac rehabilitation exercise classes in their own home. The virtual exercise classes will be delivered to participants using a videoconferencing platform. Participants in the control group will attend the research center for their cardiac rehabilitation exercise classes. Intervention group participants will receive the ECME-CR digital health platform for monitoring during the class and during the intervention period. Outcomes will be assessed at baseline and following the 8-week intervention period. The primary outcome will be exercise capacity as assessed using the 6-minute walk test. Other outcome measures will include heart rate, blood pressure, weight, percentage body fat, muscle strength, and self-reported quality of life. Semistructured interviews will also be conducted with a subset of participants to explore their experiences of using the digital platform.ResultsParticipant recruitment and data collection will begin in July 2021, and it is anticipated that the study results will be available for dissemination in spring 2022.ConclusionsThis pilot trial will inform the design of a randomized controlled trial that will assess the clinical effectiveness of the ECME-CR digital health platform.International registered report identifier (irrid)PRR1-10.2196/31855.

Dataset Information

CARE CR-Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based Cardiac Rehabilitation: a study protocol for a community-based controlled study with criterion methods.

Publications

CARE CR-Cardiovascular and cardiorespiratory Adaptations to Routine Exercise-based Cardiac Rehabilitation: a study protocol for a community-based controlled study with criterion methods.

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