HypertensionNCT02670681
Effects of Aerobic Exercise on Blood Pressure Levels of Resistant Hypertensive Subjects
A study testing Aerobic Exercise Training in people with Hypertension and Resistant Hypertension, run by Federal University of Paraíba at 1 site in Brazil.
Trial summary
The aim of this intervention study is to evaluate the acute and chronic effects of different intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of subjects classified as resistant hypertension. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Hypertension, Resistant Hypertension
- What is being tested?
- Aerobic Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2015to Mar 2019
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40 and 70 years
- Men or women
- Body mass index under 40 kg / m²
- Able to participate in exercise
- No regular physically active in the last 4 months
Who cannot join
- Smoking; with history of ischemic stroke or hemorrhagic; or coronary heart disease; or obstructive pulmonary disease or chronic restrictive; or diabetes mellitus; or chronic atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Physical Training Study Laboratory Applied to Health; Departament of Physical Education
João Pessoa, Paraíba
About this study
Official title: Effects of Different Intensities of Aerobic Exercise on Blood Pressure Levels of Resistant Hypertensive Subjects
The aim of this intervention study is to evaluate the acute and chronic effects of different intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of subjects classified as resistant hypertension. Resistant hypertensives subjects aged 40 to 70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and session control. After, the subjects will be randomly allocated into four intervention groups: mild intensity group, moderate intensity group, high intensity group and control group. In both phases, the subjects have blood pressure data recorded by ambulatory blood pressure monitoring, for clinic and ambulatory analysis. In addition, continuously be registered biological signs of blood pressure (finometer), electrocardiogram (DII derivation) and blood flow (venous occlusion plethysmography) for analysis of cardiac autonomic modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator response and peripheral vascular resistance.
- Conditions
- Hypertension, Resistant Hypertension
- Being tested
- Aerobic Exercise Training
- Keywords
- Exercise, Aerobic Exercise
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Exercise TrainingBehavioural
8 week of aerobic exercise training in different intensities.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Mild Intensity | Active comparator | The subjects engage in aerobic exercise training (8 weeks) of mild intensity (continuous). The intensity is controlled by a corresponding heart rate at anaerobic threshold. Receives: Behavioral: Aerobic Exercise Training |
| Aerobic Exercise Moderate Intensity | Active comparator | The subjects engage in aerobic exercise training (8 weeks) of moderate intensity (continuous). The intensity is controlled by a corresponding heart rate between anaerobic threshold and respiratory compensation point. Receives: Behavioral: Aerobic Exercise Training |
| Aerobic Exercise High Intensity | Active comparator | The subjects engage in aerobic exercise (8 weeks) of high intensity interval training. The intensity is controlled by a corresponding heart rate above respiratory compensation point. Receives: Behavioral: Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic, diastolic and media blood pressure
Control in blood pressure levels, assess by the method of Ambulatory Blood Pressure Monitoring (ABPM), from decrease of blood pressure in measurements pre and post-intervention with physical exercise.
Measured: Pre and post-intervention (8 weeks)
Secondary outcomes (3)
Vasodilator Response
Improve in vasodilator response, assess by the method of venous occlusion plethysmography, verified by increased of 10% in blood flow in measurements pre and post-intervention with physical exercise.
Improve in vasodilator response, assess by the method of venous occlusion plethysmography, verified by incresead of 10% in blood flow in measurements pre and post-intervention with physical exercise.
Measured: Pre and post-intervention (8 weeks)
Autonomic Modulation
Improve in autonomic modulation, assess by spectral analysis, verified by increased of 10% parasympathetic modulation and/or by decrease of 10% of sympathetic modulation in measurements pre and post-intervention with physical exercise.
Measured: Pre and post-intervention (8 weeks)
Baroreflex Sensitivity
Improve in baroreflex sensitivity, assess by alpha index, verified by increased of 10% in sensitivity in measurements pre and post-intervention with physical exercise.
Measured: Pre and post-intervention (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionOct 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leone Severino do Nascimento, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670681
- Sponsor's protocol ID
- 0602/14
- Status last verified
- Jul 2018
- First submitted
- 28 Jan 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual data are not the most important points of this study, but the results for the overall sample (external validity of the results found).
Publications
Nascimento LS, Santos AC, Lucena J, Silva L, Almeida A, Brasileiro-Santos MS. Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):250. doi: 10.1186/s13063-017-1985-5.
PubMed 28578691
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Intensities of Aerobic Exercise on Blood Pressure Levels of Resistant Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT02670681
- Acronym / sponsor ID
- 0602/14
- Conditions
- Hypertension, Resistant Hypertension
- Keywords
- Exercise, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 2 Feb 2016 (estimated)
- 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.
The aim of this intervention study is to evaluate the acute and chronic effects of different intensity (mild, moderate and high intensity) of aerobic exercise on blood pressure levels of subjects classified as resistant hypertension. Resistant hypertensives subjects aged 40 to 70, men or women with body mass index lower that 40 kg/m² are recruited and subjected in acute phase in three sessions of aerobic exercise: mild, moderate, high intensity; and session control. After, the subjects will be randomly allocated into four intervention groups: mild intensity group, moderate intensity group, high intensity group and control group. In both phases, the subjects have blood pressure data recorded by ambulatory blood pressure monitoring, for clinic and ambulatory analysis. In addition, continuously be registered biological signs of blood pressure (finometer), electrocardiogram (DII derivation) and blood flow (venous occlusion plethysmography) for analysis of cardiac autonomic modulation, vascular autonomic modulation, baroreflex sensitivity, vasodilator response and peripheral vascular resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Mild Intensity | Active comparator | Behavioral: Aerobic Exercise TrainingThe subjects engage in aerobic exercise training (8 weeks) of mild intensity (continuous). The intensity is controlled by a corresponding heart rate at anaerobic threshold. |
| Aerobic Exercise Moderate Intensity | Active comparator | Behavioral: Aerobic Exercise TrainingThe subjects engage in aerobic exercise training (8 weeks) of moderate intensity (continuous). The intensity is controlled by a corresponding heart rate between anaerobic threshold and respiratory compensation point. |
| Aerobic Exercise High Intensity | Active comparator | Behavioral: Aerobic Exercise TrainingThe subjects engage in aerobic exercise (8 weeks) of high intensity interval training. The intensity is controlled by a corresponding heart rate above respiratory compensation point. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 40 and 70 years
- Men or women
- Body mass index under 40 kg / m²
- Able to participate in exercise
- No regular physically active in the last 4 months
Key exclusion criteria (1 listed)
- Smoking; with history of ischemic stroke or hemorrhagic; or coronary heart disease; or obstructive pulmonary disease or chronic restrictive; or diabetes mellitus; or chronic atrial fibrillation.
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 |
|---|---|---|
| Aerobic Exercise Training8 week of aerobic exercise training in different intensities. | Behavioural | Aerobic Exercise High Intensity, Aerobic Exercise Mild Intensity, Aerobic Exercise Moderate Intensity |
Primary outcome
Systolic, diastolic and media blood pressure
Time frame: Pre and post-intervention (8 weeks)
Control in blood pressure levels, assess by the method of Ambulatory Blood Pressure Monitoring (ABPM), from decrease of blood pressure in measurements pre and post-intervention with physical exercise.
3 secondary outcomes
Vasodilator Response
Time frame: Pre and post-intervention (8 weeks)
Autonomic Modulation
Time frame: Pre and post-intervention (8 weeks)
Baroreflex Sensitivity
Time frame: Pre and post-intervention (8 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Derived from this study: PubMed 28578691Nascimento LS, Santos AC, Lucena J, Silva L, Almeida A, Brasileiro-Santos MS. Acute and chronic effects of aerobic exercise on blood pressure in resistant hypertension: study protocol for a randomized controlled trial. Trials. 2017 Jun 2;18(1):250. doi: 10.1186/s13063-017-1985-5.
- Individual participant dataSharing planned: No. Individual data are not the most important points of this study, but the results for the overall sample (external validity of the results found).
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Training in people with Hypertension and Resistant Hypertension, run by Federal University of Paraíba 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2018. 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?
Results are not available in the source record.
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?
Systolic, diastolic and media blood pressure (time frame: Pre and post-intervention (8 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 NCT02670681, which also lists 1 linked publication.
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 18 Jul 2018.