HypertensionNCT01963507
Effects of a Resistance Training Period on Blood Pressure of Hypertensive Elderlies: Influence of the Polymorphism of the Angiotensin Converting Enzyme
A study testing Resistance training in people with Hypertension, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The study aimed to evaluate the chronic effects of resistance training on blood pressure and biochemical exams in hypertensive elderlies and the influence of the polymorphism of the angiotensin converting enzyme in these response. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Apr 2013
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensives
- Age 60 to 85 years
- Nonactive
Who cannot join
- Orthopedic problems or other problem that prevented the exercises
- Change in drug treatment during protocol
- Absence in more than 25% of the exercise sessions
Trial locations and contacts
1 site in 1 country.
About this study
The study aimed to evaluate the chronic effects of resistance training on blood pressure and biochemical exams in hypertensive elderlies and the influence of the polymorphism of the angiotensin converting enzyme in these response.
Read the detailed description
To investigate the chronic effects of resistance training on blood pressure and biochemical exams in elderly, 135 hypertensive elderlies were divided into 2 groups: trained and control. The trained group was submitted to a resistance training period. Before the 16 weeks ACE gene was genotyped (PCR). Before and after 16 weeks, blood pressure (ambulatory), HDL-cholesterol, Total cholesterol, Glycemia, Triacylglycerol (colorimetric assay) and plasminogen activator inhibition (PAI-1), intercellular adhesion molecule (ICAM-1), vascular endothelial cell adhesion molecule (VCAM-1), Adiponectin, tumor necrosis factor alpha (TNF-alpha), C Reactive Protein, Angiotensin II, Angiotensin Converting Enzyme, Angiotensin 1-7, (ELISA assay) were measured.
- Conditions
- Hypertension
- Being tested
- Resistance training
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingBehavioural
Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR). Receives: Behavioral: Resistance training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Blood pressure was measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.
Measured: 16 weeks
Secondary outcomes (13)
HDL-cholesterol
HDL-cholesterol was analyzed by colorimetric assay, before and after 16 weeks of intervention.
Measured: 16 weeks
Total Cholesterol
Total cholesterol was analyzed by colorimetric assay, before and after 16 weeks of intervention.
Measured: 16 weeks
Glycemia
Glycemia was analyzed by colorimetric assay, before and after 16 weeks of intervention.
Measured: 16 weeks
Triacylglycerol
Triacylglycerol was analyzed by colorimetric assay, before and after 16 weeks of intervention.
Measured: 16 weeks
PAI-1
PAI-1 was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
ICAM-1
ICAM-1 was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
VCAM-1
VCAM-1 was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
Adiponectin
Adiponectin was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
TNF alpha
TNF alpha was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
C Reactive Protein
C Reactive Protein was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
Angiotensin II
Angiotensin II was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
Angiotensin Converting Enzyme
Angiotensin Converting Enzyme was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
Angiotensin 1-7
Angiotensin 1-7 was analyzed by ELISA assay, before and after 16 weeks of intervention.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startApr 2010
- Primary completionApr 2013
- Study completionApr 2013
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Alessandra Medeiros, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963507
- Sponsor's protocol ID
- ACE RT
- Status last verified
- Oct 2013
- First submitted
- 9 Oct 2013
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Resistance Training Period on Blood Pressure of Hypertensive Elderlies: Influence of the Polymorphism of the Angiotensin Converting Enzyme
- ClinicalTrials.gov ID
- NCT01963507
- Acronym / sponsor ID
- ACE RT
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 16 Oct 2013 (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 study aimed to evaluate the chronic effects of resistance training on blood pressure and biochemical exams in hypertensive elderlies and the influence of the polymorphism of the angiotensin converting enzyme in these response.
Detailed description
To investigate the chronic effects of resistance training on blood pressure and biochemical exams in elderly, 135 hypertensive elderlies were divided into 2 groups: trained and control. The trained group was submitted to a resistance training period. Before the 16 weeks ACE gene was genotyped (PCR). Before and after 16 weeks, blood pressure (ambulatory), HDL-cholesterol, Total cholesterol, Glycemia, Triacylglycerol (colorimetric assay) and plasminogen activator inhibition (PAI-1), intercellular adhesion molecule (ICAM-1), vascular endothelial cell adhesion molecule (VCAM-1), Adiponectin, tumor necrosis factor alpha (TNF-alpha), C Reactive Protein, Angiotensin II, Angiotensin Converting Enzyme, Angiotensin 1-7, (ELISA assay) were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Behavioral: Resistance trainingResistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR). |
| Control | No intervention | – |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertensives
- Age 60 to 85 years
- Nonactive
Key exclusion criteria (3 listed)
- Orthopedic problems or other problem that prevented the exercises
- Change in drug treatment during protocol
- Absence in more than 25% of the exercise sessions
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 |
|---|---|---|
| Resistance trainingResistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR). | Behavioural | Resistance training |
Primary outcome
Blood Pressure
Time frame: 16 weeks
Blood pressure was measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.
13 secondary outcomes
HDL-cholesterol
Time frame: 16 weeks
Total Cholesterol
Time frame: 16 weeks
Glycemia
Time frame: 16 weeks
Triacylglycerol
Time frame: 16 weeks
PAI-1
Time frame: 16 weeks
ICAM-1
Time frame: 16 weeks
VCAM-1
Time frame: 16 weeks
Adiponectin
Time frame: 16 weeks
TNF alpha
Time frame: 16 weeks
C Reactive Protein
Time frame: 16 weeks
Angiotensin II
Time frame: 16 weeks
Angiotensin Converting Enzyme
Time frame: 16 weeks
Angiotensin 1-7
Time frame: 16 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 16 Oct 2013.
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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 Resistance training in people with Hypertension, run by Federal University of São Paulo 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 3 inclusion and 3 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 16 Oct 2013. 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?
Blood Pressure (time frame: 16 weeks). 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 16 Oct 2013.