HypertensionRADAHNCT04218903
Resistance Plus Aerobic Training Using Different Weekly Frequencies And Hypertension
A study testing Combined training performed four times per week (CT4) and Combined training performed two times per week (CT2) in people with Hypertension and Cardiovascular Risk Factor, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Hypertension, Cardiovascular Risk Factor, Cardiovascular Diseases
- What is being tested?
- Combined training performed four times per week (CT4) and Combined training performed two times per week (CT2)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Mar 2022to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
About this study
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
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.
Read the 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.
- Being tested
- Combined training performed four times per week (CT4), Combined training performed two times per week (CT2)
- Keywords
- Aging, Ambulatory Blood Pressure Monitoring, Concurrent Training, Dose-response
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined training performed four times per week (CT4)Behavioural
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)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Combined Training 4 times per week (CT4) | Experimental | The CT4 group will perform four sessions per week of combined exercise program. This intervention will last 12 weeks. Receives: Behavioral: Combined training performed four times per week (CT4) |
| Combined Training 2 times per week (CT2) | Active comparator | The CT2 group will perform two sessions per week of combined exercise program. This intervention will last 12 weeks. Receives: Behavioral: Combined training performed two times per week (CT2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure
24h ambulatory blood pressure measured through automatic oscillometric device
Measured: Change from baseline 24-hour systolic blood pressure at 12 weeks
Secondary outcomes (6)
Systolic blood pressure
Systolic blood pressure in mmHg measured using automatic oscillometric device
Measured: Change from baseline office blood pressure at 12 weeks
Diastolic blood pressure
Diastolic blood pressure in mmHg measured using automatic oscillometric device
Measured: Change from baseline office blood pressure at 12 weeks
Cardiorespiratory fitness
Oxygen consumption at peak (VO2peak) was assessed by maximal cardiopulmonary exercise testing
Measured: Change from baseline VO2peak at 12 weeks
Upper limbs muscle strength
Performs palmar grip with the greatest possible force
Measured: Change from baseline handgrip test at 12 weeks
Lower limbs muscle strength
Sitting-rising test in a chair (maximum number of repetitions in 30 seconds and time to 5-repetions)
Measured: Change from baseline sitting-rising test at 12 weeks
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.
Measured: Change from baseline quality of life score at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Mar 2022
- Primary completion31 Dec 2024
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Rodrigo Ferrari, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218903
- Sponsor's protocol ID
- 19816719900005327
- Acronym
- RADAH
- Status last verified
- Apr 2025
- First submitted
- 3 Jan 2020
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Domingues LB, Mallmann Schneider V, Carpes L, Fuchs SC, Ferrari R. Effects of different weekly frequencies of combined training on blood pressure variability in aging adults with hypertension. Front Rehabil Sci. 2026 Oct 19;7:1925760. doi: 10.3389/fresc.2026.1925760. eCollection 2026.
PubMed 42973647Ferrari R, Schneider VM, Domingues LB, Abreu R, Lemes G, Leal-Menezes R, Tanaka H, Fuchs SC, de Oliveira Carpes L. Differential Effects of Twice vs. Four Times Weekly Combined Exercise Training in Aging Adults With Hypertension: A Randomized Clinical Trial. Scand J Med Sci Sports. 2026 Mar;36(3):e70239. doi: 10.1111/sms.70239.
PubMed 41792948
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04218903
- Acronym / sponsor ID
- RADAH / 19816719900005327
- Keywords
- Aging, Ambulatory Blood Pressure Monitoring, Concurrent Training, Dose-response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Training 4 times per week (CT4) | Experimental | Behavioral: Combined training performed four times per week (CT4)The CT4 group will perform four sessions per week of combined exercise program. This intervention will last 12 weeks. |
| Combined Training 2 times per week (CT2) | Active comparator | Behavioral: Combined training performed two times per week (CT2)The CT2 group will perform two sessions per week of combined exercise program. This intervention will last 12 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Behavioural | Combined Training 4 times per week (CT4) |
| 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). | Behavioural | Combined Training 2 times per week (CT2) |
Primary outcome
Ambulatory Blood Pressure
Time frame: Change from baseline 24-hour systolic blood pressure at 12 weeks
24h ambulatory blood pressure measured through automatic oscillometric device
6 secondary outcomes
Systolic blood pressure
Time frame: Change from baseline office blood pressure at 12 weeks
Diastolic blood pressure
Time frame: Change from baseline office blood pressure at 12 weeks
Cardiorespiratory fitness
Time frame: Change from baseline VO2peak at 12 weeks
Upper limbs muscle strength
Time frame: Change from baseline handgrip test at 12 weeks
Lower limbs muscle strength
Time frame: Change from baseline sitting-rising test at 12 weeks
Quality of life profile
Time frame: Change from baseline quality of life score at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Derived from this study: PubMed 42973647Domingues LB, Mallmann Schneider V, Carpes L, Fuchs SC, Ferrari R. Effects of different weekly frequencies of combined training on blood pressure variability in aging adults with hypertension. Front Rehabil Sci. 2026 Oct 19;7:1925760. doi: 10.3389/fresc.2026.1925760. eCollection 2026.
- Derived from this study: PubMed 41792948Ferrari R, Schneider VM, Domingues LB, Abreu R, Lemes G, Leal-Menezes R, Tanaka H, Fuchs SC, de Oliveira Carpes L. Differential Effects of Twice vs. Four Times Weekly Combined Exercise Training in Aging Adults With Hypertension: A Randomized Clinical Trial. Scand J Med Sci Sports. 2026 Mar;36(3):e70239. doi: 10.1111/sms.70239.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Ferrari, PhD principal investigator
Federal University of Rio Grande do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined training performed four times per week (CT4) and Combined training performed two times per week (CT2) in people with Hypertension and Cardiovascular Risk Factor, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulatory Blood Pressure (time frame: Change from baseline 24-hour systolic blood pressure at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218903, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.