CClinicalTrials.gg
CompletedNCT06454032Updated Jun 12, 2024

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

An interventional study of Fitness walking and Maintained lifestyle in Postmenopause Women, sponsored by Beijing Sport University. Completed at 2 sites in China. Open to female participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-12.

Sponsored by Beijing Sport University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Apr 2022, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
50 Years to 69 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Postmenopause Women

Keywords

  • Exercise
  • Postmenopause
  • Women's health
  • Metabolism
  • Sex hormone
03

In context

Lead sponsor

Beijing Sport University is the lead sponsor of 51 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 69 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Fitness walking group

    Behavioral: Fitness walking

  • Sham comparator
    Control group

    Behavioral: Maintained lifestyle

Interventions

  • BehavioralFitness walking

    Fitness walking for 12 weeks.

  • BehavioralMaintained lifestyle

    Maintained their normal lifestyle, without exercise intervention.

06

What researchers measure

Primary outcomes

  1. Systolic blood pressure (SBP)

    The change of SBP before and after intervention

    Time frame: At the beginning-at 12 weeks.

  2. Diastolic blood pressure (DBP)

    The change of DBP before and after intervention

    Time frame: At the beginning-at 12 weeks.

  3. Waist circumference (WC)

    The change of WC before and after intervention

    Time frame: At the beginning-at 12 weeks.

  4. Fasting blood glucose (FBG)

    The change of FBG before and after intervention

    Time frame: At the beginning-at 12 weeks.

  5. Triglycerides (TG)

    The change of TG before and after intervention

    Time frame: At the beginning-at 12 weeks.

  6. High-density lipoprotein cholesterol (HDL-C)

    The change of HDL-C before and after intervention

    Time frame: At the beginning-at 12 weeks.

Secondary outcomes

  1. Oestradiol (E2)

    The change of E2 before and after intervention

    Time frame: At the beginning-at 12 weeks.

  2. Testosterone (T)

    The change of T before and after intervention

    Time frame: At the beginning-at 12 weeks.

  3. Sex hormone-binding globulin (SHBG)

    The change of SHBG before and after intervention

    Time frame: At the beginning-at 12 weeks.

  4. Dehydroepiandrosterone sulphate (DHEA-S)

    The change of DHEA-S before and after intervention

    Time frame: At the beginning-at 12 weeks.

  5. Maximal oxygen uptake (VO2max)

    The change of VO2max before and after intervention

    Time frame: At the beginning-at 12 weeks.

  6. Body weight (BW)

    The change of BW before and after intervention

    Time frame: At the beginning-at 12 weeks.

  7. Height

    The change of height before and after intervention

    Time frame: At the beginning-at 12 weeks.

  8. Body mass index (BMI)

    The change of BMI before and after intervention

    Time frame: At the beginning-at 12 weeks.

07

Study locations

2 sites
  • School of Sports Medicine and Rehabilitation, Beijing Sport University
    Beijing, China
  • School of Sports Medicine and Rehabilitation
    Beijing, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06454032
Lead sponsor
Beijing Sport University
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
Apr 16, 2022
Primary completion
Sep 30, 2022
Completion
Dec 30, 2022
Last update
Jun 12, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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