- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03626792
Effect of Mat Pilates Training on Women After Menopause
7 de marzo de 2022 actualizado por: Jaqueline Pontes Batista, Federal University of Uberlandia
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Minas Gerais
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Uberlândia, Minas Gerais, Brasil, 38400-678
- Jaqueline Pontes Batista
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Hypertensive group
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.
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Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.
|
|
Otro: Normotensive group
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.
|
Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Blood pressure
Periodo de tiempo: Change from Baseline at 12 weeks
|
Resting diastolic and systolic blood pressures will be monitored by Microlife® BP 3BT0A automatic monitor in mmHg.
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Change from Baseline at 12 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Ambulatory blood pressure monitoring
Periodo de tiempo: Change from Baseline at 12 weeks
|
Ambulatory blood pressure monitoring will be monitored during 24 hours using a Dyna+ ABPM device in mmHg.
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Change from Baseline at 12 weeks
|
|
Kupperman - Blatt Index
Periodo de tiempo: Change from Baseline at 12 weeks
|
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.
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Change from Baseline at 12 weeks
|
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Cervical Scale
Periodo de tiempo: Change from Baseline at 12 weeks
|
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.
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Change from Baseline at 12 weeks
|
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Menopause Rating Scale (MRS)
Periodo de tiempo: Change from Baseline at 12 weeks
|
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.
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Change from Baseline at 12 weeks
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Sleep quality
Periodo de tiempo: Change from Baseline at 12 weeks
|
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.
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Change from Baseline at 12 weeks
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Biochemical analyzes
Periodo de tiempo: Change from Baseline at 12 weeks
|
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.
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Change from Baseline at 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Guilherme M Puga, Phd, Federal University of Uberlândia
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
5 de agosto de 2017
Finalización primaria (Actual)
20 de diciembre de 2017
Finalización del estudio (Actual)
28 de marzo de 2018
Fechas de registro del estudio
Enviado por primera vez
24 de abril de 2017
Primero enviado que cumplió con los criterios de control de calidad
9 de agosto de 2018
Publicado por primera vez (Actual)
13 de agosto de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
7 de marzo de 2022
Última verificación
1 de marzo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 68408116.9.0000.5152
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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