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Clinical Trials/NCT06454032
NCT06454032
Completed
Not Applicable

Effect of 12-week Fitness Walking Programme on Sex Hormone Levels and Risk Factors for Metabolic Syndrome in Postmenopausal Women

Beijing Sport University2 sites in 1 country30 target enrollmentApril 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postmenopause Women
Sponsor
Beijing Sport University
Enrollment
30
Locations
2
Primary Endpoint
Fasting blood glucose (FBG)
Status
Completed
Last Updated
last year

Overview

Brief Summary

Postmenopausal women were separated into two groups: one participating in a 12-week fitness walking programe as the fitness walking group, and the other maintaining their regular lifestyle as the control group. The study evaluated alterations in health markers and examined the correlation between metabolic syndrome risk factors and sex hormone levels before and after the intervention.

Detailed Description

According to the inclusion and exclusion criteria, our study invlved postmenopausal women aged from 50 to 69 years old. After the selection process, baseline assessments were conducted, including evaluations of metabolic syndrome risk factors, body morphology measurements, sex hormone levels, and cardiopulmonary exercise testing. Participants were then randomly assigned to either the fitness walking group or the control group using a random number table. Participants in the fitness walking group completed a 12-week fitness walking program, while those in the control group maintained their usual lifestyle without any intervention. During the post-intervention assessment, all baseline measurements were repeated to evaluate changes in the previously measured indicators.

Registry
clinicaltrials.gov
Start Date
April 16, 2022
End Date
December 30, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Beijing Sport University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • (1) Participants were entirely voluntary and capable of completing the full 12-week intervention process.
  • (2) Participants were postmenopausal women aged between 50 and 69 years.
  • (3) Participants had been postmenopausal for over 12 months and had not received exogenous estrogen supplementation post-menopause.

Exclusion Criteria

  • (1) Participants had a history of acute or chronic musculoskeletal disorders, cardiovascular diseases, diabetes, or other conditions that might impact their ability to engage in the intervention.
  • (2) Participants had recent hormone treatment, anti-inflammatory medication use, or other medications affecting blood indices.
  • (3) Participants experienced unstable body weight (fluctuations exceeding 2.5 kg) in the past three months.
  • (4) Participants were concurrently enrolled in other intervention studies or maintained regular exercise routines.
  • (5) Participants had smoking or alcohol consumption habits.

Outcomes

Primary Outcomes

Fasting blood glucose (FBG)

Time Frame: At the beginning-at 12 weeks.

The change of FBG before and after intervention

Waist circumference (WC)

Time Frame: At the beginning-at 12 weeks.

The change of WC before and after intervention

Diastolic blood pressure (DBP)

Time Frame: At the beginning-at 12 weeks.

The change of DBP before and after intervention

High-density lipoprotein cholesterol (HDL-C)

Time Frame: At the beginning-at 12 weeks.

The change of HDL-C before and after intervention

Systolic blood pressure (SBP)

Time Frame: At the beginning-at 12 weeks.

The change of SBP before and after intervention

Triglycerides (TG)

Time Frame: At the beginning-at 12 weeks.

The change of TG before and after intervention

Secondary Outcomes

  • Oestradiol (E2)(At the beginning-at 12 weeks.)
  • Dehydroepiandrosterone sulphate (DHEA-S)(At the beginning-at 12 weeks.)
  • Testosterone (T)(At the beginning-at 12 weeks.)
  • Sex hormone-binding globulin (SHBG)(At the beginning-at 12 weeks.)
  • Body weight (BW)(At the beginning-at 12 weeks.)
  • Maximal oxygen uptake (VO2max)(At the beginning-at 12 weeks.)
  • Height(At the beginning-at 12 weeks.)
  • Body mass index (BMI)(At the beginning-at 12 weeks.)

Study Sites (2)

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