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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03626792
Other study ID # 68408116.9.0000.5152
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 5, 2017
Est. completion date March 28, 2018

Study information

Verified date March 2022
Source Federal University of Uberlandia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date March 28, 2018
Est. primary completion date December 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - 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; Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Hypertensive group
Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.
Normotensive group
Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.

Locations

Country Name City State
Brazil Jaqueline Pontes Batista Uberlândia Minas Gerais

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Biochemical analyzes From the serum and/or plasma and saliva samples collected and stored, analyzes for lipid profile (total cholesterol and fractions, and triglycerides) and glycemia at rest and for the concentrations of inflammatory cytokines and changes in the activity of the Antioxidant system. Change from Baseline at 12 weeks
Primary Blood pressure Resting diastolic and systolic blood pressures will be monitored by Microlife® BP 3BT0A automatic monitor in mmHg. Change from Baseline at 12 weeks
Secondary Ambulatory blood pressure monitoring Ambulatory blood pressure monitoring will be monitored during 24 hours using a Dyna+ ABPM device in mmHg. Change from Baseline at 12 weeks
Secondary 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. Change from Baseline at 12 weeks
Secondary 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. Change from Baseline at 12 weeks
Secondary 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. Change from Baseline at 12 weeks
Secondary 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. Change from Baseline at 12 weeks
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