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Resistance Plus Aerobic Training Using Different Weekly Frequencies And Hypertension (RADAH)

H

Hospital de Clinicas de Porto Alegre

Status

Completed

Conditions

Hypertension
Cardiovascular Diseases
Cardiovascular Risk Factor

Treatments

Behavioral: Combined training performed four times per week (CT4)
Behavioral: Combined training performed two times per week (CT2)

Study type

Interventional

Funder types

Other

Identifiers

NCT04218903
19816719900005327

Details and patient eligibility

About

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.

Full 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.

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.

Secondary outcomes are the difference between mean change in office blood pressure, 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 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; secondary outcomes will be office blood pressure, physical fitness and quality of life. The outcomes will be assessed at baseline and at the end of 12 weeks period.

Enrollment

98 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

98 participants in 2 patient groups

Combined Training 4 times per week (CT4)
Experimental group
Description:
The CT4 group will perform four sessions per week of combined exercise program. This intervention will last 12 weeks.
Treatment:
Behavioral: Combined training performed four times per week (CT4)
Combined Training 2 times per week (CT2)
Active Comparator group
Description:
The CT2 group will perform two sessions per week of combined exercise program. This intervention will last 12 weeks.
Treatment:
Behavioral: Combined training performed two times per week (CT2)

Trial contacts and locations

1

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Central trial contact

Rodrigo Ferrari, PhD; Lucas Domingues, MSc

Data sourced from clinicaltrials.gov

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