- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06802484
Comparing the Effects of Multicomponent Exercise on Cardiovascular Health and Lipid Profiles in Premenopausal and Postmenopausal Women
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Évora, Portugal
- Bruno Figueira
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
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Experimental: Pre-Menopausic
|
The physical exercise program, lasting for 26 weeks, was conducted with an uninterrupted weekly frequency of 3 sessions, on non-consecutive days, in the late afternoon (at 7:30 PM), each lasting 60 minutes.
|
|
Experimental: Post- Menopausic
|
The physical exercise program, lasting for 26 weeks, was conducted with an uninterrupted weekly frequency of 3 sessions, on non-consecutive days, in the late afternoon (at 7:30 PM), each lasting 60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total Cholesterol
Time Frame: 26-week
|
26-week
|
|
Low-density lipoprotein Cholesterol
Time Frame: 26-week
|
26-week
|
|
High-density lipoprotein Cholesterol
Time Frame: 26-week
|
26-week
|
|
Triglycerides
Time Frame: 26-week
|
26-week
|
|
Castelli Risk Index I
Time Frame: 26-week
|
26-week
|
|
Castelli Risk Index II
Time Frame: 26-week
|
26-week
|
|
Very Low-Density Lipoprotein Cholesterol
Time Frame: 26-week
|
26-week
|
|
Glucose
Time Frame: 26-week
|
26-week
|
|
Systolic Blood Pressure
Time Frame: 26-week
|
26-week
|
|
Diastolic Blood Pressure
Time Frame: 26-week
|
26-week
|
|
Heart Rate
Time Frame: 26-week
|
26-week
|
|
Body Mass Index
Time Frame: 26-week
|
26-week
|
|
Waist Circumference
Time Frame: 26-week
|
26-week
|
|
Hip Circumference
Time Frame: 26-week
|
26-week
|
|
Waist Circumference/ Hip Circumference
Time Frame: 26-week
|
26-week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22137 (Other Identifier: City of Hope Medical Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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