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Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial.

ABSTRACT: BACKGROUND:Cardiovascular disease is the leading cause of morbidity and mortality in the world, including China. Cardiac rehabilitation (CR) has been demonstrated to be beneficial in reducing cardiovascular mortality, myocardial infarction, and cerebrovascular events. This pilot study seeks to assess the feasibility of aerobic-exercise-based CR in Chinese patients with coronary heart disease (CHD) and outcomes of aerobic metabolism capacity and molecular biomarkers. METHODS/DESIGN:This study is a single-center, pilot, randomized, controlled study that is currently being carried out at a regional hospital in Shanghai. Forty patients with CHD who underwent percutaneous coronary intervention will be randomly allocated into either the intervention group or control group. Participants in the intervention group will undergo 8 weeks of aerobic exercise with targeted intensity and participants in the control group will undergo 8 weeks of leisure exercise. The primary measurement is the feasibility of the trial; the secondary measurement is the capacity of aerobic metabolism and the exploratory measurement includes additional molecular biomarkers underlying cardiovascular function. DISCUSSION:This is the first prospective randomized and controlled clinical study in China that assesses the parameters of aerobic metabolism and comprehensively screens for substantial blood biomarkers to reveal the molecular mechanisms underlying changes in cardiovascular function after aerobic exercise with targeted intensity in participants with CHD. The success of this study will contribute to guide the design of future CR studies in patients with CHD in China. TRIAL REGISTRATION:Chinese Clinical Trial Registry, ChiCTR-IPR-17010556 . Registered on 1 June 2016.

SUBMITTER: Cao RY

PROVIDER: S-EPMC6038344 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial.

Cao Richard Y RY Zheng Hongchao H Mi Qiongyao Q Li Qing Q Yuan Wenchao W Ding Yueyou Y Yang Jian J

Trials 20180709 1

<h4>Background</h4>Cardiovascular disease is the leading cause of morbidity and mortality in the world, including China. Cardiac rehabilitation (CR) has been demonstrated to be beneficial in reducing cardiovascular mortality, myocardial infarction, and cerebrovascular events. This pilot study seeks to assess the feasibility of aerobic-exercise-based CR in Chinese patients with coronary heart disease (CHD) and outcomes of aerobic metabolism capacity and molecular biomarkers.<h4>Methods/design</h4 ...[more]

PMID: 29986745

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Project description:IntroductionThe benefits of cardiac rehabilitation (CR) on the reduction of cardiac and all-cause mortality are well documented. However, adherence remains suboptimal in China. It is clear that traditional CR does not meet the needs of many eligible patients and innovation is required to improve its application. Home-based CR (HBCR) is a cost-effective method that may be a valuable alternative for many individuals in China. In HBCR, it is often difficult to maintain an exercise intensity that is both effective and within safe limits, factors that are essential for patient safety. Mobile health interventions have the potential to overcome these obstacles and may be efficacious in improving adherence. The purpose of this study is to evaluate whether an Intelligent Exercise Rehabilitation Management System (IERMS)-based HBCR could improve adherence to CR and to assess the effects on exercise capacity, mental health, self-efficacy, quality of life and lifestyle-related risk factors.Methods and analysisWe propose a single-blinded, two-arm, randomised controlled crossover study of 70 patients with coronary heart disease (CHD). Participants will be randomly assigned in a 1:1 ratio to one of the two groups. Patients in group 1 will receive the IERMS intervention together with usual care for the first 6?weeks and usual care for the last 6?weeks, while patients assigned to group 2 will receive usual care for the first 6?weeks and will use IERMS in the last 6?weeks. The primary outcome is adherence to the programme and secondary outcomes include exercise capacity, psychological well-being, quality of life, self-efficacy and lifestyle-related risk factors. All secondary outcomes will be measured at baseline, 6?weeks and 12 weeks.Ethics and disseminationThis study has been approved by the Human Research Ethics Committee of the School of Nursing, Jilin University (HREC 2019120901). The results will be published in peer-reviewed journals and at conferences.Trial registration numberChiCTR1900028182; Pre-results.

Project description:IntroductionCoronary heart disease (CHD) is the most common cause of death worldwide. Percutaneous coronary intervention (PCI) has been shown to reduce mortality in patients with CHD. However, there are still recurrences of cardiovascular events after PCI. Cardiac rehabilitation (CR) in patients with established CHD is associated with reductions in cardiovascular mortality and hospital admissions, as well as improved quality of life. More and more clinical trials suggest that traditional Chinese exercise (TCE) plays a positive role in patients post-PCI. The primary purposes of the current study are to conduct a network meta-analysis of randomised trials to determine the effects of TCE in patients after PCI, and to separately compare the effects of tai chi, baduanjin and yijinjing on CR after PCI.Methods and analysisStudies will be retrieved from the following databases: PubMed, Embase, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang Data, Chinese BioMedical Database and Chinese Science and Technology Periodicals Database, from inception to December 2018. We will include randomised controlled trials that are related to the effects of TCE therapies in patients after PCI. The primary outcomes will be all-cause mortality, revascularisations, health-related quality of life and hospitalisations. Two reviewers will independently select eligible articles. For each included article, two reviewers will independently extract the data and assess the risk of bias by using the Cochrane risk of bias tool. Bayesian network meta-analyses will be conducted to pool all treatment effects. The ranking probabilities for the optimal intervention of various treatments (tai chi, baduanjin or yijinjing) will be estimated by the mean ranks and surface under the cumulative ranking curve. The Grading of Recommendations Assessment, Development and Evaluation System will be used to assess the quality of evidence.Ethics and disseminationThe results will be disseminated through peer-reviewed publications. They will provide consolidated evidence to inform clinicians on the potential functions of TCE in CR, and to provide reliable evidence for the application of TCE.Trial registration numberCRD42018088415.

Project description:IntroductionIt is important to ascertain the cost-effectiveness of alternative services to traditional cardiac rehabilitation while the economic credentials of the Smartphone Cardiac Rehabilitation, Assisted self-Management (SCRAM) programme among people with coronary heart disease (CHD) are unknown. This economic protocol outlines the methods for undertaking a trial-based economic evaluation of SCRAM in the real-world setting in Australia.Methods and analysisThe within-trial economic evaluation will be undertaken alongside a randomised controlled trial (RCT) designed to determine the effectiveness of SCRAM in comparison with the usual care cardiac rehabilitation (UC) alone in people with CHD. Pathway analysis will be performed to identify all the costs related to the delivery of SCRAM and UC. Both a healthcare system and a limited societal perspective will be adopted to gauge all costs associated with health resource utilisation and productivity loss. Healthcare resource use over the 6-month participation period will be extracted from administrative databases (ie, Pharmaceutical Benefits Scheme and Medical Benefits Schedule). Productivity loss will be measured by absenteeism from work (valued by human capital approach). The primary outcomes for the economic evaluation are maximal oxygen uptake (VO2max, mL/kg/min, primary RCT outcome) and quality-adjusted life years estimated from health-related quality of life as assessed by the Assessment of Quality of Life-8D instrument. The incremental cost-effectiveness ratio will be calculated using the differences in costs and benefits (ie, primary and secondary outcomes) between the two randomised groups from both perspectives with no discounting. All costs will be valued in Australian dollars for year 2020.Ethics and disseminationThe study protocol has been approved under Australia's National Mutual Acceptance agreement by the Melbourne Health Human Research Ethics Committee (HREC/18/MH/119). It is anticipated that SCRAM is a cost-effective cardiac telerehabilitation programme for people with CHD from both a healthcare and a limited societal perspective in Australia. The evaluation will provide evidence to underpin national scale-up of the programme to a wider population. The results of the economic analysis will be submitted for publication in a peer-reviewed journal.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12618001458224).

Dataset Information

Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial.

Publications

Aerobic exercise-based cardiac rehabilitation in Chinese patients with coronary heart disease: study protocol for a pilot randomized controlled trial.

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