Endothelial Dysfunction Clinical Trial
— VASCU-HEALTHOfficial title:
Physiological Response to a Training and Detraining Period in Vascular Parameters of Cardiometabolic Risk Factors Subjects: Optimizing Post-exercise Strategies to Maintain Health Benefits in Chilean Adults
Background: Although exercise training is a well described therapy for some cardiometabolic diseases such as obesity, type 2 diabetes, arterial hypertension, and metabolic syndrome, there is scarcity of knowledge about the post-exercise period term as 'detraining' where usually all physiological adaptations as cardiovascular and metabolic benefits are lost due to physical inactivity. Likewise, as some exercise training modalities as high-intensity interval training improve vascular parameters including endothelial dysfunction parameters as flow-mediated dilation (FMD%), and carotid-intima media thickness (c-IMT) during the 'training' period, there is little knowledge about how many 'volume' or 'intensity' of exercise training or physical activity per week is needed to maintain the exercise training benefits in populations with cardiometabolic risk factors such as those patients with arterial hypertension. This information will be of great interest for both improving and maintaining the vascular profile and health of Chilean adults with risk factors and to maintain a better vascular profile. Objective: To study the beneficial adaptations from the 'training' and 'detraining' period of exercise training on functional and structural vascular parameters in healthy and cardiometabolic risk factors adult subjects to improve the health profile. Methods: The investigators will conduct an experimental design of 5 groups of exercise training in healthy (controls) and hypertensive (HTN) patients (≥140 mmHg), with overweight/or obesity, men and women, with BMI ≥25 and ≤35 kg/m2, aged ≥18y, physically inactive (<150 min/week of low/moderate PA/week, or <75 min/week of vigorous PA) in the last 6 months will be invited for participating. The groups will be as follows; Group (HTNex will be compared with Group HTNcg). Group (ELEex will be compared with Group ELEcg). Group (NTex will be compared with Group NTcg). Each group will be compared in their physiological vascular adaptations before and after exercise training such as HIIT, and after 3 months of a detraining period. Results (hypothesis): The investigators hypothesized that the maintenance of vascular outcomes after the 'detraining' period is intensity-dependent in adults with HTN that participated of an exercise intervention.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Healthy, or subjects with elevated blood pressure (ELE) or arterial hypertension (HTN) - ELE and/or HTN controlled or not controlled with pharmacotherapy - With hyperglycemia, type 2 diabetes mellitus (T2DM) controlled or not controlled with pharmacotherapy - Living in urban areas of the Concepción or Talcahuano cities - Demonstrable ability to adhere to the exercise training programs - To sign the written informed consent for participating in the study Exclusion Criteria: - Altered ECG - Uncontrolled HTN (=160 mmHg SBP, or DBP >95 mmHg) - Morbid obesity (=35-40 kg/m2) - Type 1 diabetes mellitus - Cardiovascular disease (i.e., coronary artery disease) - T2DM complications such as varicose ulcer in the foot, legs, or any history of the wound, nephropathies, muscle-skeletal disorders (i.e., osteoarthrosis) that could limit exercise participation, and adaptations, where ExT can be not recommended. - Subjects under pharmacotherapy that can influence body composition such as weight- loss treatment, as well as those who are enrolled in ExT programs recently (last 3 months) |
Country | Name | City | State |
---|---|---|---|
Chile | Universidad Andres Bello | Talcahuano |
Lead Sponsor | Collaborator |
---|---|
Cristian Alvarez |
Chile,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Flow-mediated dilation in (cm) | Change in flow-mediated dilation in the brachial artery registered by a linear transducer using images from a Doppler ultrasound | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Primary | Pulse wave velocity in (m/s) | Change in pulse wave velocity in the brachial artery registered by an oscillometric cuff in the brachial artery | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Primary | Carotid intima media thickness in (cm) | Change in Carotid intima media thickness in common carotid artery registered by a linear transducer using images from a Doppler ultrasound | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Body mass in (kg) | Change in body mass registered by a digital scale in kilograms | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Height | Change in height registered by a stadiometer in centimeters | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Body mass index in (kg/m2) | Change in body mass index registered by from the calculation of the weight plus the height dividev by the suare of the height | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Body fat in (%) | Change in body fat percentage registered by from a digital bio-impedanciometer equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Skeletal muscle mass in (%) | Change in skeletal muscle mass in percentage registered by from a digital bio-impedanciometer equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Resting metbolic rate in (kcal) | Change in resting metabolic rate obtained in kcalories from a digital bio-impedanciometer equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Body age in (years) | Change in body age estimated from a digital bio-impedanciometer equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Waist circumference in (cm) | Change in waist circumference obtained from a measuring tape in centimeters | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Systolic blood pressure in (mmHg) | Change in systolic blood pressure obtained from a digital cuff sphingomanometer in mmHg from the brachial artery in seated position | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Diastolic blood pressure in (mmHg) | Change in systolic blood pressure obtained from a digital cuff sphingomanometer in mmHg from the brachial artery in seated position | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Mean arterial pressure in (mmHg) | Change in mean arterial pressure obtained from a digital cuff sphingomanometer in mmHg from the brachial artery in seated position, particularly from the data systolic and diastolic blood pressure obtained from this equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Pulse pressure in (mmHg) | Change in pulse pressure obtained from a digital cuff sphingomanometer in mmHg from the brachial artery in seated position, particularly from the data systolic and diastolic blood pressure obtained from this equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Heart rate at rest in (beats/min) | Change in heart rate at rest obtained from a digital watch cardiometer in beats/min | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Systolic blood pressure of the ankle in (mmHg) | Change in systolic blood pressure obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Diastolic blood pressure of the ankle in (mmHg) | Change in systolic blood pressure obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Partial oxygen saturation in (%) | Change in Partial oxygen saturation in (%) obtained from a digital saturometer from the index finger in seated position | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Total chlesterol in (mg/dL) | Change in total cholesterol in (mg/dL) obtained from a capillary droplet sample from the index finger from a digital portatile equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Fasting glucose in (mg/dL) | Change in fasting glucose in (mg/dL) obtained from a capillary droplet sample from the index finger from a digital portatile equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Triglycerides in (mg/dL) | Change in triglycerides in (mg/dL) obtained from a capillary droplet sample from the index finger from a digital portatile equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Augmentation index in (%) | Change in Augmentation index in (%) obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Ankle-Brachial Index in (%) | Change in Ankle-Brachial Index in (%) obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Aortic Systolic blood pressure in (mmHg) | Change in Aortic Systolic blood pressure in (mmHg) obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Aortic pulse pressure in (mmHg) | Change in Aortic pulse pressure in (mmHg) obtained from a digital cuff sphingomanometer in mmHg by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Aortic augmentation index in (%) | Change in Aortic augmentation index in (%) obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Ejection duration in (m/s) | Change in Ejection duration in (m/s) obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Diastolic reflection area | Change in Diastolic reflection area obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Systolic area index | Change in Systolic area index obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Diastolic area index | Change in Diastolic area index obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Return time of the aortic pulse wave | Change in Return time of the aortic pulse wave measured in the brachial artery obtained from a digital cuff sphingomanometer in % by the Arteriograpgh equipment from the brachial artery in supine position. | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Arterial age | Change in arterial age estimated from a digital cuff Arteriograph equipment measured from the brachial artery | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up | |
Secondary | Heart rate during exercise in (beats/min) | Heart rate measured using a cardiometer watch equipment at different power output intensities using an cycle ergometer equipment | Baseline, 6 weeks, 12 weeks after exercise training intervention, and after 6 weeks, and 12 weeks follow-up |
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