NCT06802484

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 31, 2025

Completed
Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

3 months

First QC Date

January 16, 2025

Last Update Submit

January 24, 2025

Conditions

Outcome Measures

Primary Outcomes (15)

  • Total Cholesterol

    26-week

  • Low-density lipoprotein Cholesterol

    26-week

  • High-density lipoprotein Cholesterol

    26-week

  • Triglycerides

    26-week

  • Castelli Risk Index I

    26-week

  • Castelli Risk Index II

    26-week

  • Very Low-Density Lipoprotein Cholesterol

    26-week

  • Glucose

    26-week

  • Systolic Blood Pressure

    26-week

  • Diastolic Blood Pressure

    26-week

  • Heart Rate

    26-week

  • Body Mass Index

    26-week

  • Waist Circumference

    26-week

  • Hip Circumference

    26-week

  • Waist Circumference/ Hip Circumference

    26-week

Study Arms (3)

Control

NO INTERVENTION

Pre-Menopausic

EXPERIMENTAL
Other: Experimental: Pre-Menopausic

Post- Menopausic

EXPERIMENTAL
Other: Experimental: Post- Menopausic

Interventions

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.

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.

Post- Menopausic

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bruno Figueira

Evora, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 16, 2025

First Posted

January 31, 2025

Study Start

May 1, 2024

Primary Completion

August 1, 2024

Study Completion

December 31, 2024

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations