Hypertension Clinical Trial
Official title:
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome, Abdominal Obesity and Arterial Hypertension, and Quality of Life in the Climacteric Period
Verified date | May 2022 |
Source | Universidad de Concepcion |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The estrogenic deficit characteristic of the climacteric stage is accompanied by a high incidence of health problems, such as the presence of Metabolic Syndrome risk factors that contribute to the increase of cardiovascular diseases. Objective: To determine the effect of a nursing intervention based on self-care aimed at improving the control of two metabolic syndrome risk factors (abdominal obesity and arterial hypertension) and health-related quality of life in climacteric women. Material and methods: Quasi-experimental study, non-equivalent control group design with women between 40 and 59 years old who present two risk factors of the Metabolic Syndrome (abdominal obesity and arterial hypertension) from two type C Health Centers of District 17D03 of Quito, Ecuador. Among one of the conceptual hypotheses, the researchers have Conceptual hypothesis 1: Climacteric women of the experimental group after the intervention of Nursing based on self-care improve two risk factors of MS with respect to those of the comparison group. A sample of 40 women was selected for experimental group and 40 for comparison group. Instruments and measurements: Abdominal Circumference, Blood Pressure, Menopause Rating Scale, International Physical Activity Questionnaire (IPAQ). Women in both groups received the usual care and those in the experimental group received a Nursing Intervention with technological support that included individual face-to-face nursing counseling, group education and physical activity sessions through a virtual platform for 12 weeks. Ethical requirements were considered. Expected results: It is expected that after the Nursing Intervention based on self-care the women of the experimental group will decrease the parameters of abdominal circumference, blood pressure and improve health-related quality of life.
Status | Completed |
Enrollment | 80 |
Est. completion date | December 22, 2021 |
Est. primary completion date | September 11, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 59 Years |
Eligibility | Inclusion Criteria: - Be between 40 and 59 years of age. - Abdominal circumference equal to or greater than 80 cm. - Blood pressure equal to or greater than 130/85mmHg or on antihypertensive treatment - Being able to ambulate without assistance. - Population residing in the sector in which you are registered. - Access to mobile or fixed internet service. Exclusion Criteria: - Women on hormone replacement therapy. - Women with hysterectomy and/or oophorectomy - Pregnant women. - Women with cardiovascular disease such as dyslipidemia, type II diabetes; cancer; hypothyroidism; respiratory disease; neuromuscular or terminal illness. - People who cannot read or write. |
Country | Name | City | State |
---|---|---|---|
Ecuador | Centro de Salud de San Antonio de Pichincha | Quito | Pichincha |
Lead Sponsor | Collaborator |
---|---|
Universidad de Concepcion | Universidad Central del Ecuador |
Ecuador,
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* Note: There are 41 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in abdominal obesity | Anthropometric measurements (abdominal circumference) | Until the end of the study (3 months duration) | |
Primary | Reduce systolic and diastolic blood pressure | Vital sign (systolic and diastolic blood pressure) | Until the end of the study (3 months duration) | |
Primary | Improve health-related quality of life | Instrument Menopause Rating Scale: (Minimum total value "0 points" and maximum "44 points", if the score is higher the result is negative) | Until the end of the study (3 months duration) | |
Secondary | Increase the level of physical activity | International Physical Activity Questionnaire:(Inactive: less than 10 minutes in a row in the last 7 days, Low Activity: between 10 and 149 minutes in the last 7 days and Medium or High Activity: 150 or more minutes in the last 7 days) | Until the end of the study (3 months duration) |
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