MenopauseNCT06802484
Comparing the Effects of Multicomponent Exercise on Cardiovascular Health and Lipid Profiles in Premenopausal and Postmenopausal Women
A study testing Experimental: Pre-Menopausic and Experimental: Post- Menopausic in people with Menopause and Cardiovascular, run by University of Évora at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Cardiovascular
- What is being tested?
- Experimental: Pre-Menopausic and Experimental: Post- Menopausic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 sitePortugal
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Menopause, Cardiovascular
- Being tested
- Experimental: Pre-Menopausic, Experimental: Post- Menopausic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Pre-MenopausicOther
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- MenopausicOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Pre-Menopausic | Experimental | Not described Receives: Other: Experimental: Pre-Menopausic |
| Post- Menopausic | Experimental | Not described Receives: Other: Experimental: Post- Menopausic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cholesterol
Measured: 26-week
Low-density lipoprotein Cholesterol
Measured: 26-week
High-density lipoprotein Cholesterol
Measured: 26-week
Triglycerides
Measured: 26-week
Castelli Risk Index I
Measured: 26-week
Castelli Risk Index II
Measured: 26-week
Very Low-Density Lipoprotein Cholesterol
Measured: 26-week
Glucose
Measured: 26-week
Systolic Blood Pressure
Measured: 26-week
Diastolic Blood Pressure
Measured: 26-week
Heart Rate
Measured: 26-week
Body Mass Index
Measured: 26-week
Waist Circumference
Measured: 26-week
Hip Circumference
Measured: 26-week
Waist Circumference/ Hip Circumference
Measured: 26-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 May 2024
- Primary completion1 Aug 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Évora
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Figueira, University of Évora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802484
- Sponsor's protocol ID
- 22137
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Multicomponent Exercise on Cardiovascular Health and Lipid Profiles in Premenopausal and Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06802484
- Acronym / sponsor ID
- 22137
- Conditions
- Menopause, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of ÉvoraUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Pre-Menopausic | Experimental | Other: Experimental: Pre-Menopausic |
| Post- Menopausic | Experimental | Other: Experimental: Post- Menopausic |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Pre-MenopausicThe 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. | Other | Pre-Menopausic |
| Experimental: Post- MenopausicThe 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. | Other | Post- Menopausic |
Primary outcome
Total Cholesterol
Time frame: 26-week
Low-density lipoprotein Cholesterol
Time frame: 26-week
High-density lipoprotein Cholesterol
Time frame: 26-week
Triglycerides
Time frame: 26-week
Castelli Risk Index I
Time frame: 26-week
Castelli Risk Index II
Time frame: 26-week
Very Low-Density Lipoprotein Cholesterol
Time frame: 26-week
Glucose
Time frame: 26-week
Systolic Blood Pressure
Time frame: 26-week
Diastolic Blood Pressure
Time frame: 26-week
Heart Rate
Time frame: 26-week
Body Mass Index
Time frame: 26-week
Waist Circumference
Time frame: 26-week
Hip Circumference
Time frame: 26-week
Waist Circumference/ Hip Circumference
Time frame: 26-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Pre-Menopausic and Experimental: Post- Menopausic in people with Menopause and Cardiovascular, run by University of Évora at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cholesterol (time frame: 26-week). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.