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IRCT20230528058311N1 IRCT 2023-06-12 Kerman University of Medical Sciences Investigating the effect of eight weeks of low-intensity endurance training with lower limb blood flow restriction on arterial blood pressure and cardiac function in patients with mild hypertension Investigating the effect of eight-week low-intensity endurance training with lower limb blood flow restriction on arterial blood pressure, heart performance, and serum levels of PGC1-a, Klotho, and nitric oxide metabolites in patients with mild hypertension 2023-06-10 anticipated 60 Complete https://irct.ir/trial/70412 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Blinding description: Colleagues who participate in biochemical tests and data analysis do not inform about the study groups. Samples sent to the laboratory will be numbered؛ additionally, for an individual who performs the data analysis, the study groups will be indistinctive. N/A Method of treaning to prevent high blood pressure and diminish the need to consume antihypertensive drugs.. Intervention 1: Intervention group: a group that rides a stationary bicycle at 50% VO2paek for 3 sessions a week, every other day, and each session is a maximum of 45 minutes for 8 weeks. Intervention 2: Intervention group: a group that rides a stationary bicycle 3 times a week, every other day, and each session is 45 minutes maximum for 8 weeks, with 50% of VO2paek, while the upper part of the thigh is closed with a cuff, blood flow restriction through closing The cuff will be applied in the proximal part of the thighs. The complete femoral artery occlusion pressure will be estimated through the following formula. Lower body arterial occlusion (mmHg) = (5.893 × thigh circumference) + (0.912 × systolic blood pressure) + (0.734 × diastolic blood pressure) 220.046 The cuff pressure in the exercises in the first and second weeks will be calculated and applied as 50% of the complete occlusion pressure (AOP). Intervention 3: Control group: Control group without exercise and blood flow restriction. Yes - There is a plan to make this available What will be shared: The result of the study will be shared with the participants in the Rubika social network. and it will be published with Print the article. When: The beginning of the access period for participants in Rubika, immediately after obtaining the results and for the public after the publication of the article from 2025 To whom: It will be available only to researchers working in academic and scientific institutions. Conditions: With the permission and discretion of the person in charge of the study, the data will be available to researchers working in academic and scientific institutions. Where to obtain: Afzalipur Faculty of Medicine, Department of Physiology by Dr. Siavash Jokar Postal code: 7616914115 Email: Sjokar@gmail.com 09132985770 How to obtain: The study documentation can be accessed by Correspondence with the principal investigator Comments:
public Siavash Jokar
At the end of 22 Bahman Blvd., Shahid Bahonar University, Afzalipur Faculty of Medicine
Kerman Iran (Islamic Republic of) 7616914115 +98 34 3132 0500 Sjokar@gmail.com Kerman University of Medical Sciences scientific Siavash Jokar
At the end of 22 Bahman Blvd., Shahid Bahonar University, Afzalipur Faculty of Medicine
Kerman Iran (Islamic Republic of) 7616914115 +98 34 3132 0500 Sjokar@gmail.com Kerman University of Medical Sciences Iran (Islamic Republic of) 50 - 64 years old Body mass index (BMI) less than 30 Not consumption of blood pressure drugs systolic blood pressure: 130-150mmHg ; diastolic blood pressure>80 mmHg 50 years 65 years Both Secondary hypertension Smoking Heart, respiratory, kidney, liver, metabolic, and other chronic diseases Treatment - Other Treatment - Other Treatment - Other Intervention group: a group that rides a stationary bicycle at 50% VO2paek for 3 sessions a week, every other day, and each session is a maximum of 45 minutes for 8 weeks. Intervention group: a group that rides a stationary bicycle 3 times a week, every other day, and each session is 45 minutes maximum for 8 weeks, with 50% of VO2paek, while the upper part of the thigh is closed with a cuff, blood flow restriction through closing The cuff will be applied in the proximal part of the thighs. The complete femoral artery occlusion pressure will be estimated through the following formula. Lower body arterial occlusion (mmHg) = (5.893 × thigh circumference) + (0.912 × systolic blood pressure) + (0.734 × diastolic blood pressure) 220.046 The cuff pressure in the exercises in the first and second weeks will be calculated and applied as 50% of the complete occlusion pressure (AOP). Control group: Control group without exercise and blood flow restriction Serum PGC1α level. Timepoint: Before starting training and 24 hours after the last training session. Method of measurement: Elisa. Serum levels of Klotho. Timepoint: Before starting training and 24 hours after the last training session. Method of measurement: Elisa. Serum nitrite levels. Timepoint: Before starting training and 24 hours after the last training session. Method of measurement: Photometry. Changes in blood pressure. Timepoint: One week after the intervention. Method of measurement: with a mercury barometer. Left ventricular ejection fraction. Timepoint: One week after the intervention. Method of measurement: Echocardiography by a cardiologist. Changes in biochemical parameters. Timepoint: One week after the intervention. Method of measurement: Elisa. Left ventricular fractional shortening. Timepoint: One week after the intervention. Method of measurement: Echocardiography. Left ventricular mass. Timepoint: One week after the intervention. Method of measurement: Echocardiography. Posterior wall thickness. Timepoint: One week after the intervention. Method of measurement: Echocardiography. Relative wall thickness. Timepoint: One week after the intervention. Method of measurement: Echocardiography. Isovolumic relaxation time. Timepoint: One week after the intervention. Method of measurement: Echocardiography. Mean left atrial pressure. Timepoint: One week after the intervention. Method of measurement: Echocardiography. Left ventricular end-systolic diameter. Timepoint: One week after the intervention. Method of measurement: Echocardiography. Left ventricular end-diastolic diameter. Timepoint: One week after the intervention. Method of measurement: Echocardiography. Kerman University of Medical Sciences Kerman University of Medical Sciences Kerman University of Medical Sciences Approved 2023-05-30 Ethics Committee of Kerman University of Medical Sciences The beginning of Haft Bagh Alavi axis, University of Medical Sciences campus kerman Kerman Iran (Islamic Republic of)