Physical ActivityNCT03626792
Effect of Mat Pilates Training on Women After Menopause
A study testing Hypertensive group and Normotensive group in people with Physical Activity and Blood Pressure, run by Federal University of Uberlandia at 1 site in Brazil.
Trial summary
This project aims to verify the chronic effect of Mat Pilates exercise on climacteric symptoms, ambulatory blood pressure responses, lipid and glucose profile and pro and anti-inflammatory and antioxidant markers in postmenopausal normotensive and hypertensive women. All volunteers received the same intervention. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Blood Pressure
- What is being tested?
- Hypertensive group and Normotensive group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Aug 2017to 28 Mar 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between the ages of 40 and 70;
- Be post menopausal (amenorrhea for at least 12 months);
- Medical release to perform physical activities.
- Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises;
Who cannot join
- To present a history of stroke or acute myocardial infarction;
- Smoking;
- Diagnosis of Diabetes Mellitus.
- Present renal pathologies.
- Use medications that interfere with lipid metabolism;
- Use of antihypertensive drugs (except for the hypertensive group);
- Use hormone replacement therapies;
- Present gastrointestinal conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Mat Pilates Training on Climacteric Symptoms and Physiological Changes in Women After Menopause
This project aims to verify the chronic effect of Mat Pilates exercise on climacteric symptoms, ambulatory blood pressure responses, lipid and glucose profile and pro and anti-inflammatory and antioxidant markers in postmenopausal normotensive and hypertensive women. All volunteers received the same intervention.
Read the detailed description
The Pilates program was performed three times a week for 12 weeks. Initially a familiarization was made regarding the principles of the method. All volunteers underwent 24-hour blood pressure assessment using ambulatory blood pressure measurement (ABPM) and venous blood samples were collected from fasting, saliva and questionnaires before and after the Pilates training period.
- Conditions
- Physical Activity, Blood Pressure
- Being tested
- Hypertensive group, Normotensive group
- Keywords
- Pilates, Blood Pressure, Postmenopausal women
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertensive groupOther
Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.
Normotensive groupOther
Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive group | Other | The Mat Pilates session was held lasting 50 minutes of exercises with the first 5 minutes heating and in each exercise performing 10 repetitions with 45 seconds of rest between one exercise and another. For practice, are used only mats, and alternative devices such as the Swiss ball and the flexible ring, as well as body weight and the force of gravity as resistance factors and Borg's subjective perception of effort scale for intensity parameters. The 20 exercises were chosen through the classic exercises thus classified by the creator of the Joseph Pilates method.During the sessions, volunteers were instructed on correct breathing without performing the valsalva maneuver. Receives: Other: Hypertensive group |
| Normotensive group | Other | The Mat Pilates session was held lasting 50 minutes of exercises with the first 5 minutes heating and in each exercise performing 10 repetitions with 45 seconds of rest between one exercise and another. For practice, are used only mats, and alternative devices such as the Swiss ball and the flexible ring, as well as body weight and the force of gravity as resistance factors and Borg's subjective perception of effort scale for intensity parameters. The 20 exercises were chosen through the classic exercises thus classified by the creator of the Joseph Pilates method.During the sessions, volunteers were instructed on correct breathing without performing the valsalva maneuver. Receives: Other: Normotensive group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Resting diastolic and systolic blood pressures will be monitored by Microlife® BP 3BT0A automatic monitor in mmHg.
Measured: Change from Baseline at 12 weeks
Secondary outcomes (5)
Ambulatory blood pressure monitoring
Ambulatory blood pressure monitoring will be monitored during 24 hours using a Dyna+ ABPM device in mmHg.
Measured: Change from Baseline at 12 weeks
Kupperman - Blatt Index
The climacteric symptoms will be evaluated by the following questionnaire Kupperman - Blatt Index. The questionnaire has scores that from 0 to 19 indicate mild symptoms, 20 to 35 moderate and greater than 35 symptoms of severe climacteric.
Measured: Change from Baseline at 12 weeks
Cervical Scale
The climacteric symptoms will be evaluated by the following questionnaire Cervical Scale. The questionnaire does not have scales. Indicates only a high or low score regarding the presence of climacteric symptoms.
Measured: Change from Baseline at 12 weeks
Menopause Rating Scale (MRS)
The climacteric symptoms will be evaluated by the following questionnaire Menopause Rating Scale (MRS). The scores from 0 to 4 of the questionnaire indicate absence of symptoms, as well as from 5 to 8 presence of mild symptoms, 9 to 15 moderate and greater than 16 symptoms of severe climacteric.
Measured: Change from Baseline at 12 weeks
Sleep quality
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).A score of 0 to 4 indicates a good quality of sleep, 5 to 10 quality of bad sleep and greater than 10 the presence of sleep disorder.
Measured: Change from Baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start5 Aug 2017
- Primary completion20 Dec 2017
- Study completion28 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Model description
- * Group 1 - Hypertensive: Composed of hypertensive women who participated in a training program with Pilates exercises in the soil associated to the daily antihypertensive of each one. * Group 2 - Normotensives: Composed of normotensive women who participated in a training program with solo Pilates exercises without antihypertensive presence. Both groups underwent 12 weeks of Pilates training.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaqueline Pontes Batista, Federal University of Uberlandia
- Investigators
- Guilherme M Puga, Phd, Study director, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626792
- Sponsor's protocol ID
- 68408116.9.0000.5152
- Status last verified
- Mar 2022
- First submitted
- 24 Apr 2017
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mat Pilates Training on Climacteric Symptoms and Physiological Changes in Women After Menopause
- ClinicalTrials.gov ID
- NCT03626792
- Acronym / sponsor ID
- 68408116.9.0000.5152
- Conditions
- Physical Activity, Blood Pressure
- Keywords
- Pilates, Blood Pressure, Postmenopausal women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- 5 Aug 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 28 Mar 2018 (actual)
- First posted
- 13 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.
This project aims to verify the chronic effect of Mat Pilates exercise on climacteric symptoms, ambulatory blood pressure responses, lipid and glucose profile and pro and anti-inflammatory and antioxidant markers in postmenopausal normotensive and hypertensive women. All volunteers received the same intervention.
Detailed description
The Pilates program was performed three times a week for 12 weeks. Initially a familiarization was made regarding the principles of the method. All volunteers underwent 24-hour blood pressure assessment using ambulatory blood pressure measurement (ABPM) and venous blood samples were collected from fasting, saliva and questionnaires before and after the Pilates training period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Group 1 - Hypertensive: Composed of hypertensive women who participated in a training program with Pilates exercises in the soil associated to the daily antihypertensive of each one. * Group 2 - Normotensives: Composed of normotensive women who participated in a training program with solo Pilates exercises without antihypertensive presence. Both groups underwent 12 weeks of Pilates training.
| Arm | Type | Receives |
|---|---|---|
| Hypertensive group | Other | Other: Hypertensive groupThe Mat Pilates session was held lasting 50 minutes of exercises with the first 5 minutes heating and in each exercise performing 10 repetitions with 45 seconds of rest between one exercise and another. For practice, are used only mats, and alternative devices such as the Swiss ball and the flexible ring, as well as body weight and the force of gravity as resistance factors and Borg's subjective perception of effort scale for intensity parameters. The 20 exercises were chosen through the classic exercises thus classified by the creator of the Joseph Pilates method.During the sessions, volunteers were instructed on correct breathing without performing the valsalva maneuver. |
| Normotensive group | Other | Other: Normotensive groupThe Mat Pilates session was held lasting 50 minutes of exercises with the first 5 minutes heating and in each exercise performing 10 repetitions with 45 seconds of rest between one exercise and another. For practice, are used only mats, and alternative devices such as the Swiss ball and the flexible ring, as well as body weight and the force of gravity as resistance factors and Borg's subjective perception of effort scale for intensity parameters. The 20 exercises were chosen through the classic exercises thus classified by the creator of the Joseph Pilates method.During the sessions, volunteers were instructed on correct breathing without performing the valsalva maneuver. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women between the ages of 40 and 70;
- Be post menopausal (amenorrhea for at least 12 months);
- Medical release to perform physical activities.
- Do not present physical problems or cardiovascular complications that prevent the performance of physical exercises;
Key exclusion criteria (8 listed)
- To present a history of stroke or acute myocardial infarction;
- Smoking;
- Diagnosis of Diabetes Mellitus.
- Present renal pathologies.
- Use medications that interfere with lipid metabolism;
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 |
|---|---|---|
| Hypertensive groupPilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises. | Other | Hypertensive group |
| Normotensive groupPilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises. | Other | Normotensive group |
Primary outcome
Blood pressure
Time frame: Change from Baseline at 12 weeks
Resting diastolic and systolic blood pressures will be monitored by Microlife® BP 3BT0A automatic monitor in mmHg.
5 secondary outcomes
Ambulatory blood pressure monitoring
Time frame: Change from Baseline at 12 weeks
Kupperman - Blatt Index
Time frame: Change from Baseline at 12 weeks
Cervical Scale
Time frame: Change from Baseline at 12 weeks
Menopause Rating Scale (MRS)
Time frame: Change from Baseline at 12 weeks
Sleep quality
Time frame: Change from Baseline at 12 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 22 Mar 2022.
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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.
Guilherme M Puga, Phd study director
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertensive group and Normotensive group in people with Physical Activity and Blood Pressure, run by Federal University of Uberlandia 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 4 inclusion and 8 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 22 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 (time frame: Change from Baseline at 12 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 22 Mar 2022.