HypertensionNCT02987452
Acute Effects of Different Exercises on Blood Pressure in Hypertensive Subjects
A study testing aerobic exercise, resistance exercise and combined exercise in people with Hypertension, run by Heitor Moreno Junior.
Trial summary
Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive (RHTN) patients, have not been investigated… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- aerobic exercise, resistance exercise and combined exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2018
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the diagnosis recommended by the AHA Statement on Resistant Hypertension (2008)
- a 6-month period clinic follow-up
- give written informed consent form
Who cannot join
- secondary Hypertension
- pseudoresistance hypertension (poor medication adherence and white coat hypertension)
- patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases, heart failure
- pregnant women
- smoking
- regular physical activity
- mental or physical limitation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hemodynamic, Autonomic and Inflammatory Answers to Different Types of Exercises in Resistant Hypertensive Patients: an Metabolomic Approach
Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive (RHTN) patients, have not been investigated yet.
Read the detailed description
Objective: The investigators aim to evaluate the acute effects of aerobic, resistance and combined (aerobic+ resistance) exercise on the BP, hemodynamic and inflammatory parameters, as well as arterial stiffness in RHTN patients compared to mild to moderate hypertensive (HTN) and normotensive (NT) subjects. Design and Methods: This interventional, randomized, single-blind, crossover study will be conducted in 30 patients (RHTN=10, HTN=10, and NT=10) regularly followed in the Outpatient Resistant Hypertension Clinic at UNICAMP- Brazil. All the subjects will be submitted to a previous adaptation of physical activity, especially to determine the load to be implemented in each patient. Then, the modalities of physical exercises (aerobic, resistance and combined) will be randomly performed in three isolated sessions, which will consist of: a) Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test; b) resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes; c) combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes. Body composition (plethysmography) and cardiorespiratory functional capacity (ergometry) will be determined before the physical training. In addition, the investigators will assess BP recording (by Finometer, office and ambulatory BP), arterial stiffness (by pulse wave velocity, Sphygmocor CPV system), plasma biomarkers (TNF-α, interleukins -1, -6, -10, and -17 by ELISA) in pre and post periods of each physical exercise. Results: Since the physical exercise in its different modalities provides chronic effects on BP in HTN patients, the investigators hypothesized that the isolated (aerobic and resistance) and combined exercise can acutely promote changes in BP levels in RHTN patients when compared to the participants counterparts. Secondarily, some biological mechanisms related to BP control (vascular function and cytokines production) may also be involved in these possible alterations. Conclusion: The investigators expect to define whether a physical exercise program applied to RHTN patients has medical relevance in a realistic clinical setting. These findings may guide the prescription of physical activity as an additional therapeutic approach, in order to decrease the cardiovascular risk associated to these subjects.
- Conditions
- Hypertension
- Being tested
- aerobic exercise, resistance exercise, combined exercise
- Keywords
- exercise, resistant hypertension, blood pressure
- 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 exerciseOther
Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test
resistance exerciseOther
resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes
combined exerciseOther
combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Experimental | Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test Receives: Other: aerobic exercise; Other: resistance exercise; Other: combined exercise |
| resistance exercise | Active comparator | resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes Receives: Other: aerobic exercise; Other: resistance exercise; Other: combined exercise |
| combined exercise | Active comparator | combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes Receives: Other: aerobic exercise; Other: resistance exercise; Other: combined exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure in mmHg
systolic blood pressure will be assessed for 15 minutes in baseline, 60 minutes and 24 hours post each interventions.
Measured: 15 minutes
Secondary outcomes (5)
arterial stiffness
by pulse wave velocity, Sphygmocor CPV system
Measured: baseline and 60 minutes post each intervention
ambulatory blood pressure monitoring
ambulatory blood pressure will be assessed in baseline and post each intervention
Measured: baseline and post each intervention
interleukin 6
interleukin 6 will be assessed by ELISA
Measured: baseline, 60 minutes and 24 hours post each intervention
interleukin 10
interleukin 10 will be assessed by ELISA
Measured: baseline, 60 minutes and 24 hours post each intervention
tumor necrosis factor alpha
tumor necrosis factor alpha will be assessed by ELISA
Measured: baseline, 60 minutes and 24 hours post each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heitor Moreno Junior
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heitor Moreno Junior, University of Campinas, Brazil
- Investigators
- Nayara F. Pires, PhD student, Principal investigator, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987452
- Sponsor's protocol ID
- 55942216.4.0000.5404
- Status last verified
- Dec 2016
- First submitted
- 6 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fraccari-Pires N, Coelho-Junior HJ, Gambassi BB, Cabral de Faria AP, Ritter AMV, Gasparetti CS, Pioli MR, Ruberti OM, Ferreira-Melo SE, Moreno H, Rodrigues B. Cardiovascular Autonomic Responses to Aerobic, Resistance and Combined Exercises in Resistance Hypertensive Patients. Biomed Res Int. 2022 Apr 20;2022:8202610. doi: 10.1155/2022/8202610. eCollection 2022.
PubMed 35496038
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic, Autonomic and Inflammatory Answers to Different Types of Exercises in Resistant Hypertensive Patients: an Metabolomic Approach
- ClinicalTrials.gov ID
- NCT02987452
- Acronym / sponsor ID
- 55942216.4.0000.5404
- Conditions
- Hypertension
- Keywords
- exercise, resistant hypertension, blood pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Heitor Moreno JuniorUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 9 Dec 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.
Lifestyle changes might reduce cardiovascular risk due to the decrease in blood pressure (BP). However, whether combining aerobic and resistance exercises affect BP and hemodynamic parameters, as well as arterial stiffness and inflammation markers in resistant hypertensive (RHTN) patients, have not been investigated yet.
Detailed description
Objective: The investigators aim to evaluate the acute effects of aerobic, resistance and combined (aerobic+ resistance) exercise on the BP, hemodynamic and inflammatory parameters, as well as arterial stiffness in RHTN patients compared to mild to moderate hypertensive (HTN) and normotensive (NT) subjects. Design and Methods: This interventional, randomized, single-blind, crossover study will be conducted in 30 patients (RHTN=10, HTN=10, and NT=10) regularly followed in the Outpatient Resistant Hypertension Clinic at UNICAMP- Brazil. All the subjects will be submitted to a previous adaptation of physical activity, especially to determine the load to be implemented in each patient. Then, the modalities of physical exercises (aerobic, resistance and combined) will be randomly performed in three isolated sessions, which will consist of: a) Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test; b) resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes; c) combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes. Body composition (plethysmography) and cardiorespiratory functional capacity (ergometry) will be determined before the physical training. In addition, the investigators will assess BP recording (by Finometer, office and ambulatory BP), arterial stiffness (by pulse wave velocity, Sphygmocor CPV system), plasma biomarkers (TNF-α, interleukins -1, -6, -10, and -17 by ELISA) in pre and post periods of each physical exercise. Results: Since the physical exercise in its different modalities provides chronic effects on BP in HTN patients, the investigators hypothesized that the isolated (aerobic and resistance) and combined exercise can acutely promote changes in BP levels in RHTN patients when compared to the participants counterparts. Secondarily, some biological mechanisms related to BP control (vascular function and cytokines production) may also be involved in these possible alterations. Conclusion: The investigators expect to define whether a physical exercise program applied to RHTN patients has medical relevance in a realistic clinical setting. These findings may guide the prescription of physical activity as an additional therapeutic approach, in order to decrease the cardiovascular risk associated to these subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | Experimental | Other: aerobic exercise, Other: resistance exercise, Other: combined exerciseAerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test |
| resistance exercise | Active comparator | Other: aerobic exercise, Other: resistance exercise, Other: combined exerciseresistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes |
| combined exercise | Active comparator | Other: aerobic exercise, Other: resistance exercise, Other: combined exercisecombined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the diagnosis recommended by the AHA Statement on Resistant Hypertension (2008)
- a 6-month period clinic follow-up
- give written informed consent form
Key exclusion criteria (7 listed)
- secondary Hypertension
- pseudoresistance hypertension (poor medication adherence and white coat hypertension)
- patients with symptomatic ischemic heart disease, impaired renal function, liver disease and history of stroke, myocardial infarction and peripheral vascular diseases, heart failure
- pregnant women
- smoking
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 exerciseAerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test | Other | aerobic exercise, combined exercise, resistance exercise |
| resistance exerciseresistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes | Other | aerobic exercise, combined exercise, resistance exercise |
| combined exercisecombined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes | Other | aerobic exercise, combined exercise, resistance exercise |
Primary outcome
systolic blood pressure in mmHg
Time frame: 15 minutes
systolic blood pressure will be assessed for 15 minutes in baseline, 60 minutes and 24 hours post each interventions.
5 secondary outcomes
arterial stiffness
Time frame: baseline and 60 minutes post each intervention
ambulatory blood pressure monitoring
Time frame: baseline and post each intervention
interleukin 6
Time frame: baseline, 60 minutes and 24 hours post each intervention
interleukin 10
Time frame: baseline, 60 minutes and 24 hours post each intervention
tumor necrosis factor alpha
Time frame: baseline, 60 minutes and 24 hours post each intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Derived from this study: PubMed 35496038Fraccari-Pires N, Coelho-Junior HJ, Gambassi BB, Cabral de Faria AP, Ritter AMV, Gasparetti CS, Pioli MR, Ruberti OM, Ferreira-Melo SE, Moreno H, Rodrigues B. Cardiovascular Autonomic Responses to Aerobic, Resistance and Combined Exercises in Resistance Hypertensive Patients. Biomed Res Int. 2022 Apr 20;2022:8202610. doi: 10.1155/2022/8202610. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Nayara F. Pires, PhD student principal investigator
University of Campinas
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise, resistance exercise and combined exercise in people with Hypertension, run by Heitor Moreno Junior.
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 3 inclusion and 7 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 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Nayara F. Pires, PhD student (+551935219538, nayarafraccari@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
systolic blood pressure in mmHg (time frame: 15 minutes). 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 NCT02987452, 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 14 Dec 2016.