HypertensionNCT02249507
Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Trial
A study testing aerobic exercise in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
Aerobic exercise has the potential to diminish blood pressure values. The aim of this study is to determine whether this potential is also applicable for those with resistant hypertension and whether exercise intensity plays a role in this context. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2013to May 2015
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- resistant-to-treatment hypertensive subjects (24h ambulatory BP above 130/80, or daytime ambulatory BP above 135/85, or night-time ambulatory BP above 120/70 in spite use of 3 anti-hypertensive medications of different classes, being one diuretic; or use of 4 or more anti-hypertensive medications).
Who cannot join
- Muscle or skeletal abnormalities that preclude effort, abnormal exercise stress test, major illnesses that would preclude exercise effort or could influence in the outcome variables (pulmonary disease, valve disease, renal insufficiency, etc.)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Randomized Controlled Trial
Aerobic exercise has the potential to diminish blood pressure values. The aim of this study is to determine whether this potential is also applicable for those with resistant hypertension and whether exercise intensity plays a role in this context. We hypothesize that performing an aerobic exercise session reduces blood pressure values in resistant hypertensive patients in a dose-response relation with exercise intensity.
Read the detailed description
Exercise prescription is gathering great importance in preventive health. Several organizations endorse the performance of at least 150min/wk of moderate intensity or 75min/wk of higher intensities in order to achieve better health parameters in different contexts. Aerobic exercise is known to be an effective way to diminish BP levels post-session. These responses are widely applicable in hypertensive subjects, acting in aid of BP management treatment. Although these benefits of aerobic exercise are well known, few studies explore the potential of this intervention in resistant-to-treatment patients. Moreover, the effects different intensities of aerobic exercise in this population is scarce. Thus, the aim of this study is to determine the magnitude of BP responses, if there is any, of resistant hypertensive subjects to two different intensities of aerobic exercise, compared with a control session. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise testing and three randomized intervention sessions: control, 50%HRmax and 75%HRmax. Prior and immediately after all intervention sessions (during 1h), forearm blood flow and reactive hyperemia will be assessed by venous occlusion plethysmography. After the sessions, 24h blood pressure will be assessed with an ambulatory blood pressure monitoring system.
- Conditions
- Hypertension
- Being tested
- aerobic exercise
- Keywords
- Resistant Hypertension, Aerobic Exercise
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | sited rest for 45 minutes |
| higher intensity aerobic exercise | Experimental | 45 minutes of aerobic exercise at 75%HRmax Receives: Other: aerobic exercise |
| lower intensity aerobic exercise | Experimental | 45 minutes of aerobic exercise at 50%HRmax Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure Monitoring
Measured: 22h
Secondary outcomes (2)
Forearm blood flow
Accessed by venous occlusion plethysmography. Compared with pre-intervention values
Measured: 1h
Reactive hyperemia
Accessed by venous occlusion plethysmography.
Measured: pre and 30min post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Umpierre, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249507
- Sponsor's protocol ID
- 13-0309
- Other IDs
- 13-0309
- Status last verified
- Aug 2015
- First submitted
- 23 Sep 2014
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Exercise in Postexercise Cardiovascular Responses in Resistant Hypertension: a Cross-over Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02249507
- Acronym / sponsor ID
- 13-0309
- Conditions
- Hypertension
- Keywords
- Resistant Hypertension, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 Sep 2014 (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.
Aerobic exercise has the potential to diminish blood pressure values. The aim of this study is to determine whether this potential is also applicable for those with resistant hypertension and whether exercise intensity plays a role in this context. We hypothesize that performing an aerobic exercise session reduces blood pressure values in resistant hypertensive patients in a dose-response relation with exercise intensity.
Detailed description
Exercise prescription is gathering great importance in preventive health. Several organizations endorse the performance of at least 150min/wk of moderate intensity or 75min/wk of higher intensities in order to achieve better health parameters in different contexts. Aerobic exercise is known to be an effective way to diminish BP levels post-session. These responses are widely applicable in hypertensive subjects, acting in aid of BP management treatment. Although these benefits of aerobic exercise are well known, few studies explore the potential of this intervention in resistant-to-treatment patients. Moreover, the effects different intensities of aerobic exercise in this population is scarce. Thus, the aim of this study is to determine the magnitude of BP responses, if there is any, of resistant hypertensive subjects to two different intensities of aerobic exercise, compared with a control session. For that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise testing and three randomized intervention sessions: control, 50%HRmax and 75%HRmax. Prior and immediately after all intervention sessions (during 1h), forearm blood flow and reactive hyperemia will be assessed by venous occlusion plethysmography. After the sessions, 24h blood pressure will be assessed with an ambulatory blood pressure monitoring system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –sited rest for 45 minutes |
| higher intensity aerobic exercise | Experimental | Other: aerobic exercise45 minutes of aerobic exercise at 75%HRmax |
| lower intensity aerobic exercise | Experimental | Other: aerobic exercise45 minutes of aerobic exercise at 50%HRmax |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- resistant-to-treatment hypertensive subjects (24h ambulatory BP above 130/80, or daytime ambulatory BP above 135/85, or night-time ambulatory BP above 120/70 in spite use of 3 anti-hypertensive medications of different classes, being one diuretic; or use of 4 or more anti-hypertensive medications).
Key exclusion criteria (1 listed)
- Muscle or skeletal abnormalities that preclude effort, abnormal exercise stress test, major illnesses that would preclude exercise effort or could influence in the outcome variables (pulmonary disease, valve disease, renal insufficiency, etc.)
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 (cycloergometer) at selected intensity (HRmax or equivalent) | Other | higher intensity aerobic exercise, lower intensity aerobic exercise |
Primary outcome
Ambulatory Blood Pressure Monitoring
Time frame: 22h
2 secondary outcomes
Forearm blood flow
Time frame: 1h
Reactive hyperemia
Time frame: pre and 30min post
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 20 Aug 2015.
Related trials for Hypertension
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Recruiting
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Heart Failure, Heart Diseases
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
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.
Daniel Umpierre, PhD principal investigator
Federal University of Health Science of Porto Alegre
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 in people with Hypertension, 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 1 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: finished, as of the sponsor's last update on 20 Aug 2015. 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 Monitoring (time frame: 22h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2015.