HypertensionNCT03615625
Post-exercise Hypotension After a Power Training Session in Older Adults With Hypertension
A study testing Power Training Session in people with Hypertension, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The main purpose of the present study was to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension. As secondary outcomes, the investigators compared post-exercise hypotension, BP variability, and endothelial function between older men and women… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Power Training Session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- 12 Jun 2018to 1 Jan 2020
- 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 75 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;
- Non-engaged in structured programs of exercise for the last 3 months since the beginning of this study;
- Able to perform the proposed exercises.
Who cannot join
- Underlying cardiovascular disease previously diagnosticated by a doctor, occurred in the last 24 months, such as: acute myocardial infarction, angina, stroke or heart failure;
- Diseases that reduce life expectancy;
- Smokers and ex-smokers for less than six months;
- BMI > 39.9 kg/m²
- diabetic proliferative retinopathy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Effect of a Power Training Session on Ambulatory Blood Pressure in Older Adults With Hypertension: a Randomized Crossover Trial
The main purpose of the present study was to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension. As secondary outcomes, the investigators compared post-exercise hypotension, BP variability, and endothelial function between older men and women with hypertension.
The working hypothesis was that a single bout of power exercise would decrease both office and 24 h BP in comparison to a non-exercising control session and men and women would respond differently after a power training session.
Read the detailed description
Participants randomly performed two experimental sessions: power exercise training (PT) and non-exercising control at seated rest (Con). They maintained their current antihypertensive medications throughout the trial. Each session was composed of 20 min of rest in the supine position, 40 min of PT or Con protocols, and 60 min of rest in supine position after protocols. The PT was composed of 3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds. During the Con, the participants remained seated rest on the same exercise machines, but without any exercise. Standardized office BP was performed before and during the first hour (in intervals of 15 min) after exercise and control sessions. Together with the office BP evaluation in the pre and post sessions, the endothelium-dependent brachial vascular function was evaluated using Flow-mediated dilation. Afterwards, participants underwent 24h ambulatory BP monitoring..
- Conditions
- Hypertension
- Being tested
- Power Training Session
- Keywords
- Exercise, Aging, Ambulatory Blood Pressure Monitoring, Power 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.
Power Training SessionBehavioural
3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Control session | No intervention | Control session without any exercise. The participants remained in seated rest throughout 40 min |
| Power Training Session | Experimental | The power training session lasted 40 min, in which the participants performed a resistance exercise session using high velocity contractions during the exercises characterizing a power training session Receives: Behavioral: Power Training Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure Monitoring
Mean 24-h, day-time, night-time of blood pressure in mmHg will be assessed after each experimental session (power training session and control session)
Measured: 24 hours after control and power training exercise session
Secondary outcomes (4)
Office Systolic Blood Pressure
Systolic blood pressure in mmHg will be measured using automatic oscillometric before and after each experimental session throughout one hour
Measured: 60 minutes after control and power training exercise session
Office Diastolic Blood Pressure
Diastolic blood pressure in mmHg will be measured using automatic oscillometric before and after each experimental session throughout one hour
Measured: 60 minutes after control and power training exercise session
Endothelial Function
Flow-mediated dilatation (FMD) assessed through high resolution ultrasonography before and after each experimental session throughout one hour
Measured: 60 minutes after control and power training exercise session
Blood Pressure Variability
Systolic and diastolic BP values obtained in the 24-hour ambulatory blood pressure monitoring, with valid measures included in a programmed software to calculate the average real variability of these measures.
Measured: 24 hours after control and power training exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start12 Jun 2018
- Primary completion20 Jul 2019
- Study completion1 Jan 2020
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
- Model description
- A randomized controlled clinical trial with crossover design was performed in order to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 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
- NCT03615625
- Sponsor's protocol ID
- 85210618.1.0000.5327
- Status last verified
- Jan 2021
- First submitted
- 31 Jul 2018
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Oliveira Carpes L, Domingues LB, Schimitt R, Fuchs SC, Alhalimi T, Tanaka H, Ferrari R. Sex Differences in Post-exercise Hypotension, Ambulatory Blood Pressure Variability, and Endothelial Function After a Power Training Session in Older Adults. Front Physiol. 2021 Jul 16;12:657373. doi: 10.3389/fphys.2021.657373. eCollection 2021.
PubMed 34335289
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Power Training Session on Ambulatory Blood Pressure in Older Adults With Hypertension: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT03615625
- Acronym / sponsor ID
- 85210618.1.0000.5327
- Conditions
- Hypertension
- Keywords
- Exercise, Aging, Ambulatory Blood Pressure Monitoring, Power Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 6 Aug 2018 (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.
The main purpose of the present study was to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension. As secondary outcomes, the investigators compared post-exercise hypotension, BP variability, and endothelial function between older men and women with hypertension.
The working hypothesis was that a single bout of power exercise would decrease both office and 24 h BP in comparison to a non-exercising control session and men and women would respond differently after a power training session.
Detailed description
Participants randomly performed two experimental sessions: power exercise training (PT) and non-exercising control at seated rest (Con). They maintained their current antihypertensive medications throughout the trial. Each session was composed of 20 min of rest in the supine position, 40 min of PT or Con protocols, and 60 min of rest in supine position after protocols. The PT was composed of 3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds. During the Con, the participants remained seated rest on the same exercise machines, but without any exercise. Standardized office BP was performed before and during the first hour (in intervals of 15 min) after exercise and control sessions. Together with the office BP evaluation in the pre and post sessions, the endothelium-dependent brachial vascular function was evaluated using Flow-mediated dilation. Afterwards, participants underwent 24h ambulatory BP monitoring..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial with crossover design was performed in order to evaluate the effect of a power training session on office and 24h ambulatory blood pressure in older adults with hypertension.
| Arm | Type | Receives |
|---|---|---|
| Control session | No intervention | –Control session without any exercise. The participants remained in seated rest throughout 40 min |
| Power Training Session | Experimental | Behavioral: Power Training SessionThe power training session lasted 40 min, in which the participants performed a resistance exercise session using high velocity contractions during the exercises characterizing a power training session |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Office blood pressure between 130-179 and 80-110 mmHg for systolic and diastolic blood pressure, respectively;
- Non-engaged in structured programs of exercise for the last 3 months since the beginning of this study;
- Able to perform the proposed exercises.
Key exclusion criteria (5 listed)
- Underlying cardiovascular disease previously diagnosticated by a doctor, occurred in the last 24 months, such as: acute myocardial infarction, angina, stroke or heart failure;
- Diseases that reduce life expectancy;
- Smokers and ex-smokers for less than six months;
- BMI > 39.9 kg/m²
- diabetic proliferative retinopathy.
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 |
|---|---|---|
| Power Training Session3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed "as fast as possible" while the eccentric phase lasted 1-2 seconds. | Behavioural | Power Training Session |
Primary outcome
Ambulatory Blood Pressure Monitoring
Time frame: 24 hours after control and power training exercise session
Mean 24-h, day-time, night-time of blood pressure in mmHg will be assessed after each experimental session (power training session and control session)
4 secondary outcomes
Office Systolic Blood Pressure
Time frame: 60 minutes after control and power training exercise session
Office Diastolic Blood Pressure
Time frame: 60 minutes after control and power training exercise session
Endothelial Function
Time frame: 60 minutes after control and power training exercise session
Blood Pressure Variability
Time frame: 24 hours after control and power training exercise session
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 14 Jan 2021.
- Derived from this study: PubMed 34335289de Oliveira Carpes L, Domingues LB, Schimitt R, Fuchs SC, Alhalimi T, Tanaka H, Ferrari R. Sex Differences in Post-exercise Hypotension, Ambulatory Blood Pressure Variability, and Endothelial Function After a Power Training Session in Older Adults. Front Physiol. 2021 Jul 16;12:657373. doi: 10.3389/fphys.2021.657373. eCollection 2021.
- 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 Power Training Session 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 3 inclusion and 5 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 14 Jan 2021. 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: 24 hours after control and power training exercise session). 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 NCT03615625, 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 Jan 2021; AzTrials last refreshed its copy on 29 Oct 2026.