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

Primary Purpose

Hypertension, Cardiovascular Risk Factor, Cardiovascular Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Combined training performed four times per week (CT4)
Combined training performed two times per week (CT2)
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Aging, Ambulatory Blood Pressure Monitoring, Concurrent Training, Dose-response

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combined Training 4 times per week (CT4)

Combined Training 2 times per week (CT2)

Arm Description

The CT4 group will perform four sessions per week of combined exercise program. This intervention will last 12 weeks.

The CT2 group will perform two sessions per week of combined exercise program. This intervention will last 12 weeks.

Outcomes

Primary Outcome Measures

Ambulatory Blood Pressure
24h ambulatory blood pressure measured through automatic oscillometric device
Glycohemoglobin
Glycohemoglobin in A1C percentual measured through a venous blood sample using a high performance liquid chromatography method

Secondary Outcome Measures

Systolic blood pressure
Systolic blood pressure in mmHg measured using automatic oscillometric device
Diastolic blood pressure
Diastolic blood pressure in mmHg measured using automatic oscillometric device
Endothelial function
Flow-mediated dilatation assessed through high resolution ultrasonography
Cardiorespiratory fitness
Oxygen consumption at peak (VO2peak) was assessed by maximal cardiopulmonary exercise testing
Upper limbs muscle strength
Performs palmar grip with the greatest possible force
Lower limbs muscle strength
Sitting-rising test in a chair (maximum number of repetitions in 30 seconds and time to 5-repetions)
Lower limbs muscle power
Vertical countermovement jump test
Upper limbs muscle power
Horizontal medicine ball shot put test
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.

Full Information

First Posted
January 3, 2020
Last Updated
March 30, 2022
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
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1. Study Identification

Unique Protocol Identification Number
NCT04218903
Brief Title
Resistance Plus Aerobic Training Using Different Weekly Frequencies And Hypertension
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Cardiovascular Risk Factor, Cardiovascular Diseases
Keywords
Aging, Ambulatory Blood Pressure Monitoring, Concurrent Training, Dose-response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combined Training 4 times per week (CT4)
Arm Type
Experimental
Arm Description
The CT4 group will perform four sessions per week of combined exercise program. This intervention will last 12 weeks.
Arm Title
Combined Training 2 times per week (CT2)
Arm Type
Active Comparator
Arm Description
The CT2 group will perform two sessions per week of combined exercise program. This intervention will last 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Combined training performed four times per week (CT4)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Combined training performed two times per week (CT2)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Ambulatory Blood Pressure
Description
24h ambulatory blood pressure measured through automatic oscillometric device
Time Frame
Change from baseline 24-hour systolic blood pressure at 12 weeks
Title
Glycohemoglobin
Description
Glycohemoglobin in A1C percentual measured through a venous blood sample using a high performance liquid chromatography method
Time Frame
Change from baseline glycohemoglobin at 12 weeks
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure in mmHg measured using automatic oscillometric device
Time Frame
Change from baseline office blood pressure at 12 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure in mmHg measured using automatic oscillometric device
Time Frame
Change from baseline office blood pressure at 12 weeks
Title
Endothelial function
Description
Flow-mediated dilatation assessed through high resolution ultrasonography
Time Frame
Change from baseline flow-mediated dilation at 12 weeks
Title
Cardiorespiratory fitness
Description
Oxygen consumption at peak (VO2peak) was assessed by maximal cardiopulmonary exercise testing
Time Frame
Change from baseline VO2peak at 12 weeks
Title
Upper limbs muscle strength
Description
Performs palmar grip with the greatest possible force
Time Frame
Change from baseline handgrip test at 12 weeks
Title
Lower limbs muscle strength
Description
Sitting-rising test in a chair (maximum number of repetitions in 30 seconds and time to 5-repetions)
Time Frame
Change from baseline sitting-rising test at 12 weeks
Title
Lower limbs muscle power
Description
Vertical countermovement jump test
Time Frame
Change from baseline vertical countermovement jump at 12 weeks
Title
Upper limbs muscle power
Description
Horizontal medicine ball shot put test
Time Frame
Change from baseline horizontal medicine ball shot put at 12 weeks
Title
Quality of life profile
Description
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.
Time Frame
Change from baseline quality of life score at 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodrigo Ferrari, PhD
Phone
555133598449
Email
rod.ferrari84@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lucas Domingues, MSc
Phone
555133598449
Email
lucas.bdomingues@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo Ferrari, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Ferrari, PhD
Phone
55 51 33596349
Email
get@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Lucas Betti Domingues, MSc
Phone
55 51 33596349
Email
get@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Resistance Plus Aerobic Training Using Different Weekly Frequencies And Hypertension

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