Resistance Plus Aerobic Training Using Different Weekly Frequencies And Hypertension

Hypertension Clinical Trial

— RADAH  

Official title:

Comparison of Different Weekly Frequencies of Combined Training on Ambulatory Blood Pressure and Other Cardiovascular Risk Factors in Individuals With Hypertension: a Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04218903
• Other study ID #: 19816719900005327
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2022
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Rodrigo Ferrari, PhD
• Phone: 555133598449
• Email: rod.ferrari84[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Combined training is a cornerstone intervention to improve functionality and to reduce blood pressure in older adults with hypertension. Acute blood pressure lowering after exercise seems to predict the extent of blood pressure reduction after chronic training interventions. Based on that, the same weekly amount of exercise performed more frequently could be more beneficial to blood pressure management. The aim of the present study is to evaluate the effects of a combined exercise program performed four versus two times per week on 24-h ambulatory blood pressure and other cardiovascular risk factors in older individuals with hypertension.

Description:

Chronic blood pressure reduction due regular exercise seems to result from the sum of the acute decreases that follows each exercise bout (i.e., post-exercise hypotension), a physiological effect associated with chronic blood pressure reduction that may predict the extent of blood pressure lowering after chronic training interventions. Based on this, the same weekly amount of exercise performed more frequently, splitting the total overload into multiple sessions, could be more beneficial for blood pressure control. Although physical exercise guidelines suggest a total weekly volume in minutes (i.e., 150 minutes per week), it's unclear if the same amount of exercise performed in different weekly frequencies could induce different blood pressure responses. In addition, other important cardiovascular risk factors such as glycemic levels can also be influenced by exercise frequency. Reduction in glycosylated hemoglobin is associated with exercise frequency in diabetic patients, reinforcing the relevance to compare exercise interventions using different weekly training frequencies.

The aim of the present study is to evaluate the effects of a combined exercise program performed four versus two times per week on 24-h ambulatory blood pressure and other cardiovascular risk factors in middle-aged and older individuals with hypertension. The main outcome is the change from baseline to 12 weeks of follow-up in 24-h, daytime, nighttime systolic and diastolic ambulatory blood pressure, and glycosylated hemoglobin between the intervention groups. Secondary outcomes are the difference between mean change in endothelial function, as well as cardiorespiratory fitness, muscular strength and quality of life. We anticipate that at 12 weeks, combined exercise program, performed four or two times per week with equalized weekly volume/overload, will improve all outcomes in comparison to the baseline values and these improvements in blood pressure and glycosylated hemoglobin will be more pronounced in four times per week group when compared with two times per week group.

This study will be a randomized, parallel group, two-arm, superiority trial. Ninety-eight participants aged 50-80 years with a previous physician diagnosis of hypertension will be randomized to perform two or four sessions per week of combined training using the same total weekly overload. Primary outcomes will be 24-h ambulatory blood pressure and glycosylated hemoglobin; secondary outcomes will be endothelial function, physical fitness and quality of life. The outcomes will be assessed at baseline and at the end of 12 weeks period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: December 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively or taking at least one antihypertensive medication

Not engaged in structured exercise programs (3 or more times per week) in the last 3 months before the study

Exclusion Criteria:

Physical and muscular injuries that limit to accomplishment of the different training proposed in the study

Underlying cardiovascular disease in the last 24 months such as acute myocardial infarction, angina, stroke or heart failure

Health conditions that limit physical exercise perform, such as lung disease, valvar heart disease, renal failure

Diseases that reduce life expectancy

BMI > 39.9 kg/m²

Diabetic proliferative retinopathy

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Hypertension

Intervention

Behavioral:
• Combined training performed four times per week (CT4)
CT4 will perform four combined training sessions per week throughout 12 weeks. Each session will be composed 10-15 minutes of resistance exercise (1-4 sets of 10-15 repetitions, using an intensity corresponding to 50-70%1RM in 3 exercises) followed by 20-25 minutes of aerobic exercise (walking or running at an intensity corresponding to 60-70% of VO2peak).
• Combined training performed two times per week (CT2)
CT2 will perform two combined training sessions per week throughout 12 weeks. Each session will be composed 20-30 minutes of resistance exercise (1-4 sets of 10-15 repetitions, using an intensity corresponding to 50-70%1RM in 6 exercises) followed by 40-50 minutes of aerobic exercise (walking or running at an intensity corresponding to 60-70% of VO2peak).

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ambulatory Blood Pressure	24h ambulatory blood pressure measured through automatic oscillometric device	Change from baseline 24-hour systolic blood pressure at 12 weeks
Primary	Glycohemoglobin	Glycohemoglobin in A1C percentual measured through a venous blood sample using a high performance liquid chromatography method	Change from baseline glycohemoglobin at 12 weeks
Secondary	Systolic blood pressure	Systolic blood pressure in mmHg measured using automatic oscillometric device	Change from baseline office blood pressure at 12 weeks
Secondary	Diastolic blood pressure	Diastolic blood pressure in mmHg measured using automatic oscillometric device	Change from baseline office blood pressure at 12 weeks
Secondary	Endothelial function	Flow-mediated dilatation assessed through high resolution ultrasonography	Change from baseline flow-mediated dilation at 12 weeks
Secondary	Cardiorespiratory fitness	Oxygen consumption at peak (VO2peak) was assessed by maximal cardiopulmonary exercise testing	Change from baseline VO2peak at 12 weeks
Secondary	Upper limbs muscle strength	Performs palmar grip with the greatest possible force	Change from baseline handgrip test at 12 weeks
Secondary	Lower limbs muscle strength	Sitting-rising test in a chair (maximum number of repetitions in 30 seconds and time to 5-repetions)	Change from baseline sitting-rising test at 12 weeks
Secondary	Lower limbs muscle power	Vertical countermovement jump test	Change from baseline vertical countermovement jump at 12 weeks
Secondary	Upper limbs muscle power	Horizontal medicine ball shot put test	Change from baseline horizontal medicine ball shot put at 12 weeks
Secondary	Quality of life profile	World Health Organization Quality of Life questionnaire (WHOQOL-BREF) contains 26 questions using a likert scale (scores range 1 to 5) and has been stratified in 4 domains (physical health, psychological, social relationships and environment). Higher scores mean a better outcome.	Change from baseline quality of life score at 12 weeks