Clinical trial NCT06802484: Comparing the Effects of Multicomponent Exercise on Cardiovascular Health and Lipid Profiles in Premenopausal and Postmenopausal Women
Official title: Comparing the Effects of Multicomponent Exercise on Cardiovascular Health and Lipid Profiles in Premenopausal and Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Cardiovascular
Lead sponsor: University of Évora
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 75
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Background: The present study aimed to examine the effects of a 26-week multicomponent exercise program on lipid and lipoprotein profiles, blood pressure, and anthropometric parameters in healthy but sedentary premenopausal and postmenopausal women aged 40-60.

Method: The program, comprising resistance, balance, flexibility, and aerobic exercises, aimed to identify group-specific responses and establish the program's efficacy in mitigating cardiovascular risks. Seventy-five women were recruited, and 38 completed the intervention. Participants were categorized into premenopausal (n=18), postmenopausal (n=10), and control groups (n=10). Key measures included total cholesterol, low- and high-density lipoprotein cholesterol, triglycerides, glucose, systolic and diastolic blood pressure, and anthropometric variables. Statistical analyses employed the Shapiro-Wilk test, paired t-tests, Wilcoxon tests, and Kruskal-Wallis tests, with α=0.05.


Eligibility criteria: Inclusion Criteria:

* women aged between 40 and 60 years old;
* healthy, asymptomatic, and non-smoking;
* medical diagnosis favouring the engagement in physical-sporting activities;
* absence of clinical history related to alcoholism or uncontrolled metabolic disease;
* no clinical prescription for hypotensive pharmacological intake, cholesterol reduction, hormonal replacement therapy, or any other intervention capable of inducing alterations in lipid and lipoprotein metabolism; or
* abnormal blood sample results.

Exclusion Criteria:

* non-fulfilment of inclusion criteria;
* clinical history characterized by symptoms related to cardiovascular disease (CVD), including stroke (CVA) and coronary vascular disease (CVD), renal or hepatic disease, musculoskeletal disorders, or rheumatoid conditions that may impede full participation in the exercise program.

Primary outcomes:
measure: Total Cholesterol
timeFrame: 26-week
measure: Low-density lipoprotein Cholesterol
timeFrame: 26-week
measure: High-density lipoprotein Cholesterol
timeFrame: 26-week
measure: Triglycerides
timeFrame: 26-week
measure: Castelli Risk Index I
timeFrame: 26-week
measure: Castelli Risk Index II
timeFrame: 26-week
measure: Very Low-Density Lipoprotein Cholesterol
timeFrame: 26-week
measure: Glucose
timeFrame: 26-week
measure: Systolic Blood Pressure
timeFrame: 26-week
measure: Diastolic Blood Pressure
timeFrame: 26-week
measure: Heart Rate
timeFrame: 26-week
measure: Body Mass Index
timeFrame: 26-week
measure: Waist Circumference
timeFrame: 26-week
measure: Hip Circumference
timeFrame: 26-week
measure: Waist Circumference/ Hip Circumference
timeFrame: 26-week
Secondary outcomes:
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: Bruno Figueira
Study officials:
References: