Clinical trial NCT04218903: Resistance Plus Aerobic Training Using Different Weekly Frequencies And Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Cardiovascular Risk Factor
Cardiovascular Diseases
Keywords: Aging
Ambulatory Blood Pressure Monitoring
Concurrent Training
Dose-response
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Federal University of Rio Grande do Sul
First posted: 2020-01-06
Enrollment: 98
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Ambulatory Blood Pressure
timeFrame: Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: Change from baseline office blood pressure at 12 weeks
measure: Diastolic blood pressure
timeFrame: Change from baseline office blood pressure at 12 weeks
measure: Cardiorespiratory fitness
timeFrame: Change from baseline VO2peak at 12 weeks
measure: Upper limbs muscle strength
timeFrame: Change from baseline handgrip test at 12 weeks
measure: Lower limbs muscle strength
timeFrame: Change from baseline sitting-rising test at 12 weeks
measure: Quality of life profile
timeFrame: Change from baseline quality of life score at 12 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Rodrigo Ferrari, PhD
role: PRINCIPAL_INVESTIGATOR
References: