HypertensionNCT03254225
Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability
A study testing Resistance training in people with Hypertension, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability of hypertensive elderlies patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training, an the other will remain sedentary. Read more about this study
- Who is it for?
- Ages 60 to 80 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
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Apr 2018to 30 Apr 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensives
- Age 60 to 80 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
This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability of hypertensive elderlies patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training, an the other will remain sedentary.
Read the detailed description
This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability using time and frequency-domains by ECG tracks. Will be assessed the blood pressure using the ambulatory blood pressure monitoring method of hypertensive elderly patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal repetition, an the ontrol group will remain sedentary.
- Conditions
- Hypertension
- Being tested
- Resistance training
- Keywords
- Hypertension, Elderly, Resistance training, Heart rate variability
- 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 | in this arm, the group will remain sedentary for the same period of the experimental group, and they will be invited to engage on the raining program after the sedentary period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure change due to resistance training
Blood pressure will be measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.
Measured: 16 weeks
Secondary outcomes (3)
Heart rate variability - Time domain - change due to resistance training
Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
Measured: 16 weeks
Heart rate variability - Frequency domain - change due to resistance training
Heart rate variability will be collected by electrocardiogram before and after 16 weeks of intervention
Measured: 16 weeks
Heart rate variability - Non-linear methods - change due to resistance training
Heart rate variability will be collected by electrocardiogram 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 posted18 Aug 2017
- Study start4 Apr 2018
- Primary completion30 Jan 2020
- Study completion30 Apr 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Alessandra Medeiros, Federal University of São Paulo
- Investigators
- Fabio T Montrezol, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254225
- Sponsor's protocol ID
- CEP1844640
- Status last verified
- Mar 2022
- First submitted
- 11 Aug 2017
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sixteen Weeks of Resistance Training in Hypertensive Elderly, Effects on Heart Rate Variability
- ClinicalTrials.gov ID
- NCT03254225
- Acronym / sponsor ID
- CEP1844640
- Conditions
- Hypertension
- Keywords
- Hypertension, Elderly, Resistance training, Heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 18 Aug 2017 (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.
This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability of hypertensive elderlies patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training, an the other will remain sedentary.
Detailed description
This study evaluates the inffluence of 16 weeks of resistance training on heart rate variability using time and frequency-domains by ECG tracks. Will be assessed the blood pressure using the ambulatory blood pressure monitoring method of hypertensive elderly patients. All volunteers will be divided in two groups, one will participate in a protocol of sixteen weeks of resistance training prescribed with a relative workload of 50% of 1 maximal repetition, an the ontrol group will remain sedentary.
Study design
- Primary purpose
- Treatment
- Allocation
- 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 | –in this arm, the group will remain sedentary for the same period of the experimental group, and they will be invited to engage on the raining program after the sedentary period |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hypertensives
- Age 60 to 80 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 change due to resistance training
Time frame: 16 weeks
Blood pressure will be measured by Ambulatorial Monitoring Blood Pressure before and after 16 weeks of intervention.
3 secondary outcomes
Heart rate variability - Time domain - change due to resistance training
Time frame: 16 weeks
Heart rate variability - Frequency domain - change due to resistance training
Time frame: 16 weeks
Heart rate variability - Non-linear methods - change due to resistance training
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 17 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Fabio T Montrezol principal investigator
Federal University of São Paulo
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 17 Mar 2022. 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 change due to resistance training (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 17 Mar 2022.