Blood PressureNCT04044638
Eight Week Strength Training Reduces Blood Pressure of Middle Age Women
A study testing Resistance trainining in people with Blood Pressure and Resistance Training, run by Universidade Regional do Cariri at 1 site in Brazil.
Trial summary
Introduction: Strength training (ST) is an important non-pharmacological means to reduce blood pressure (BP). Objective: To verify the pressure response of women after 8 weeks of ST. Read more about this study
- Who is it for?
- Ages 18 to 59 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Resistance Training, Women
- What is being tested?
- Resistance trainining
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2018to 30 Apr 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 18 to 59 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females between 18 and 59 years old, sedentary or who had not been engaged in any physical activity in the last 6 months, plus the availability of time three times a week in the afternoon shift.
Who cannot join
- Morbid obesity (BMI> 40 kg.m-2), presenting any osteo-articular dysfunction that limited the performance of exercises in strength training, women who were classified in category 3 (known serious disease) after risk stratification of the College American of Sports Medicine and also, who presented cardiovascular diseases, autonomic neuropathy, diabetes and hypertension controlled or not.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Alfredo Anderson Teixeira de Araujo
Juazeiro do Norte, Ceará, 63024-620
About this study
Introduction: Strength training (ST) is an important non-pharmacological means to reduce blood pressure (BP). Objective: To verify the pressure response of women after 8 weeks of ST. Method: Fourteen women were divided into young group (YG) and middle age (MAG) and submitted to ST for 8 weeks, lasting 60 minutes in 11 alternating exercises per segment with intensity of 12 to 13 on the subjective perception scale of effort. BP was verified at weeks 1, 4 and 8.
Read the detailed description
The sample consisted of 14 women, which were divided into two groups: young group (YG = 7) and middle age group (MAG = 7). Inclusion criteria were: females aged 18 to 59 years, sedentary or who had not been engaged in any physical activity in the last 6 months, and the availability of time three times a week in the afternoon shift. Exclusion criteria were: morbid obesity (BMI> 40 kg.m-2), presenting any osteo-articular dysfunction.
After the adaptation period, resistance exercise sessions were started, which were performed 3 times a week on alternate days, in which each session lasted 60 minutes, and performed for a period of 8 weeks. Each session consisted of 10-minute warm-up on the treadmill or bicycle, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. In the first, fourth and eighth week, pre-exercise blood pressure (BP) was verified, in which the participants sat for a period of 10 minutes at rest, in a comfortable chair, with legs uncrossed, feet flat on the floor, back leaning on the chair, left arm at heart level and palm up1 to measure BP using a G * Tech-branded automatic digital device (MASTER MA100 model).
- Conditions
- Blood Pressure, Resistance Training, Women
- Being tested
- Resistance trainining
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance traininingOther
Resistance training sessions were held 3 times a week, in which each session lasted 60 minutes and was performed for a period of 8 weeks. Each session consisted of 10-minute warm-up, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. In the first, fourth and eighth week, pre-exercise blood pressure (BP) was verified, in which the participants sat for a period of 10 minutes at rest, in a comfortable chair, with legs uncrossed, feet flat on the floor, back leaning on the chair, left arm at heart level and palm up to measure BP using a G * Tech-branded automatic digital device (MASTER model).
| Study group | Role | What they receive |
|---|---|---|
| Young Group | Experimental | Young women who underwent 8 weeks of training and had their blood pressure checked at baseline and after 4 and 8 weeks of training.
Resistance training sessions were held 3 times a week, in which each session lasted 60 minutes and was performed for a period of 8 weeks. Each session consisted of 10-minute warm-up, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. Receives: Other: Resistance trainining |
| Middle-aged Group | Experimental | Middle-aged women women who underwent 8 weeks of training and had their blood pressure checked at baseline and after 4 and 8 weeks of training.
Resistance training sessions were held 3 times a week, in which each session lasted 60 minutes and was performed for a period of 8 weeks. Each session consisted of 10-minute warm-up, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. Receives: Other: Resistance trainining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Increased blood pressure in young group and reduced blood pressure in middle age group
Measured: Four weeks
Blood pressure
Increased blood pressure in young group and reduced blood pressure in middle age group
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start5 Mar 2018
- Primary completion2 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The sample consisted of 14 women, which were divided into two groups: young group (YG = 7) and middle age group (MAG = 7).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Regional do Cariri
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfredo Anderson Teixeira de Araujo, Universidade Regional do Cariri
- Investigators
- Alfredo Anderson T de Araujo, MSc, Principal investigator, Universidade Regional do Cariri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04044638
- Sponsor's protocol ID
- 2.821.574
- Status last verified
- Aug 2019
- First submitted
- 1 Aug 2019
- Last updated
- 5 Aug 2019
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eight Week Strength Training Reduces Blood Pressure of Middle Age Women
- ClinicalTrials.gov ID
- NCT04044638
- Acronym / sponsor ID
- 2.821.574
- Conditions
- Blood Pressure, Resistance Training, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidade Regional do CaririUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Aug 2019 (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.
Introduction: Strength training (ST) is an important non-pharmacological means to reduce blood pressure (BP). Objective: To verify the pressure response of women after 8 weeks of ST. Method: Fourteen women were divided into young group (YG) and middle age (MAG) and submitted to ST for 8 weeks, lasting 60 minutes in 11 alternating exercises per segment with intensity of 12 to 13 on the subjective perception scale of effort. BP was verified at weeks 1, 4 and 8.
Detailed description
The sample consisted of 14 women, which were divided into two groups: young group (YG = 7) and middle age group (MAG = 7). Inclusion criteria were: females aged 18 to 59 years, sedentary or who had not been engaged in any physical activity in the last 6 months, and the availability of time three times a week in the afternoon shift. Exclusion criteria were: morbid obesity (BMI> 40 kg.m-2), presenting any osteo-articular dysfunction.
After the adaptation period, resistance exercise sessions were started, which were performed 3 times a week on alternate days, in which each session lasted 60 minutes, and performed for a period of 8 weeks. Each session consisted of 10-minute warm-up on the treadmill or bicycle, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. In the first, fourth and eighth week, pre-exercise blood pressure (BP) was verified, in which the participants sat for a period of 10 minutes at rest, in a comfortable chair, with legs uncrossed, feet flat on the floor, back leaning on the chair, left arm at heart level and palm up1 to measure BP using a G * Tech-branded automatic digital device (MASTER MA100 model).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The sample consisted of 14 women, which were divided into two groups: young group (YG = 7) and middle age group (MAG = 7).
| Arm | Type | Receives |
|---|---|---|
| Young Group | Experimental | Other: Resistance traininingYoung women who underwent 8 weeks of training and had their blood pressure checked at baseline and after 4 and 8 weeks of training. Resistance training sessions were held 3 times a week, in which each session lasted 60 minutes and was performed for a period of 8 weeks. Each session consisted of 10-minute warm-up, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. |
| Middle-aged Group | Experimental | Other: Resistance traininingMiddle-aged women women who underwent 8 weeks of training and had their blood pressure checked at baseline and after 4 and 8 weeks of training. Resistance training sessions were held 3 times a week, in which each session lasted 60 minutes and was performed for a period of 8 weeks. Each session consisted of 10-minute warm-up, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females between 18 and 59 years old, sedentary or who had not been engaged in any physical activity in the last 6 months, plus the availability of time three times a week in the afternoon shift.
Key exclusion criteria (1 listed)
- Morbid obesity (BMI> 40 kg.m-2), presenting any osteo-articular dysfunction that limited the performance of exercises in strength training, women who were classified in category 3 (known serious disease) after risk stratification of the College American of Sports Medicine and also, who presented cardiovascular diseases, autonomic neuropathy, diabetes and hypertension controlled or not.
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 traininingResistance training sessions were held 3 times a week, in which each session lasted 60 minutes and was performed for a period of 8 weeks. Each session consisted of 10-minute warm-up, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. In the first, fourth and eighth week, pre-exercise blood pressure (BP) was verified, in which the participants sat for a period of 10 minutes at rest, in a comfortable chair, with legs uncrossed, feet flat on the floor, back leaning on the chair, left arm at heart level and palm up to measure BP using a G * Tech-branded automatic digital device (MASTER model). | Other | Middle-aged Group, Young Group |
Primary outcome
Blood pressure
Time frame: Four weeks
Increased blood pressure in young group and reduced blood pressure in middle age group
Blood pressure
Time frame: Eight weeks
Increased blood pressure in young group and reduced blood pressure in middle age group
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 5 Aug 2019.
- 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.
Alfredo Anderson T de Araujo, MSc principal investigator
Universidade Regional do Cariri
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 trainining in people with Blood Pressure and Resistance Training, run by Universidade Regional do Cariri 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 5 Aug 2019. 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: Four weeks). The study lists 2 primary outcomes in all. 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 5 Aug 2019.