Feasibility study to assess the delivery of a novel isometric exercise intervention for people with Stage 1 hypertension in the NHS

East Kent Hospitals University NHS Foundation Trust0 个研究点目标入组 84 人开始时间: 2020年9月18日最近更新: 2024年9月9日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34711266/ (added 01/11/2021) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36931669/ critical discussion of study feasibility and adaptations during the COVID-19 pandemic (added 24/03/2023) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39187872/ Secondary outcome: embedded qualitative study on participant and stakeholder perceptions (added 29/08/2024)

•1. Currently taking anti-hypertensive medication
•2. White coat hypertension, as evidenced by averaged home systolic BP <135 mmHg
•3. Inability to undertake study intervention (isometric exercise)
•4. Previous history of any of the following:
•4.1. Diabetes mellitus (Type 1 or type 2)
•4.2. Ischaemic heart disease (myocardial infarction and/or coronary angina and/or coronary revascularization procedure)
•4.3. Moderate or severe stenotic or regurgitant heart valve disease
•4.4. Atrial or ventricular arrhythmia
•4.5. Stroke or transient ischaemic attack
•4.6. Aortic aneurysm and/or peripheral arterial disease
•4.7. Uncorrected congenital or inherited heart condition
•5. Estimated glomerular filtration rate <45 ml/min (calculated using CKD-EPI or MDRD formulae, and taking most recent documented results)
•6. Documented left ventricular ejection fraction <45% and/or left ventricular hypertrophy (by either echocardiography or standard ECG criteria e.g. Sokolow-Lyon)
•7. Documented urine albumin:creatinine ratio >3.5 mg/mmol
•8. Inability to provide informed consent
•9. If female, pregnancy or currently breastfeeding
•10. Enrolled in another Clinical Trial of an Interventional Medicinal Product or Medical Device or another interventional study
•11. Medical condition that, in the opinion of the investigator, would make the participant unsuitable for the study

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