Effect of 12-week FW Programme on Sex Hormone Levels and Risk Factors for MS in Postmenopausal Women

June 6, 2024 updated by: Beijing Sport University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • School of Sports Medicine and Rehabilitation, Beijing Sport University
      • Beijing, China
        • School of Sports Medicine and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Control group
Behavioral: Maintained lifestyle
Maintained their normal lifestyle, without exercise intervention.
Experimental: Fitness walking group
Behavioral: Fitness walking
Fitness walking for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure (SBP)
Time Frame: At the beginning-at 12 weeks.
The change of SBP before and after intervention
At the beginning-at 12 weeks.
Diastolic blood pressure (DBP)
Time Frame: At the beginning-at 12 weeks.
The change of DBP before and after intervention
At the beginning-at 12 weeks.
Waist circumference (WC)
Time Frame: At the beginning-at 12 weeks.
The change of WC before and after intervention
At the beginning-at 12 weeks.
Fasting blood glucose (FBG)
Time Frame: At the beginning-at 12 weeks.
The change of FBG before and after intervention
At the beginning-at 12 weeks.
Triglycerides (TG)
Time Frame: At the beginning-at 12 weeks.
The change of TG before and after intervention
At the beginning-at 12 weeks.
High-density lipoprotein cholesterol (HDL-C)
Time Frame: At the beginning-at 12 weeks.
The change of HDL-C before and after intervention
At the beginning-at 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oestradiol (E2)
Time Frame: At the beginning-at 12 weeks.
The change of E2 before and after intervention
At the beginning-at 12 weeks.
Testosterone (T)
Time Frame: At the beginning-at 12 weeks.
The change of T before and after intervention
At the beginning-at 12 weeks.
Sex hormone-binding globulin (SHBG)
Time Frame: At the beginning-at 12 weeks.
The change of SHBG before and after intervention
At the beginning-at 12 weeks.
Dehydroepiandrosterone sulphate (DHEA-S)
Time Frame: At the beginning-at 12 weeks.
The change of DHEA-S before and after intervention
At the beginning-at 12 weeks.
Maximal oxygen uptake (VO2max)
Time Frame: At the beginning-at 12 weeks.
The change of VO2max before and after intervention
At the beginning-at 12 weeks.
Body weight (BW)
Time Frame: At the beginning-at 12 weeks.
The change of BW before and after intervention
At the beginning-at 12 weeks.
Height
Time Frame: At the beginning-at 12 weeks.
The change of height before and after intervention
At the beginning-at 12 weeks.
Body mass index (BMI)
Time Frame: At the beginning-at 12 weeks.
The change of BMI before and after intervention
At the beginning-at 12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Sport University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2022

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

December 30, 2022

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EOFWOSHLARFMSIPP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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