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Completed

NCT Number: NCT06454032

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

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Key information

Age range

50 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Sports Medicine and Rehabilitation, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fitness walking

Behavioral

Fitness walking for 12 weeks.

Maintained lifestyle

Behavioral

Maintained their normal lifestyle, without exercise intervention.

Primary outcomes

  1. Systolic blood pressure (SBP)

    Time frame: At the beginning-at 12 weeks.

    The change of SBP before and after intervention

  2. Diastolic blood pressure (DBP)

    Time frame: At the beginning-at 12 weeks.

    The change of DBP before and after intervention

  3. Waist circumference (WC)

    Time frame: At the beginning-at 12 weeks.

    The change of WC before and after intervention

  4. Fasting blood glucose (FBG)

    Time frame: At the beginning-at 12 weeks.

    The change of FBG before and after intervention

  5. Triglycerides (TG)

    Time frame: At the beginning-at 12 weeks.

    The change of TG before and after intervention

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

    Time frame: At the beginning-at 12 weeks.

    The change of HDL-C before and after intervention

Secondary outcomes

  1. Oestradiol (E2)

    Time frame: At the beginning-at 12 weeks.

    The change of E2 before and after intervention

  2. Testosterone (T)

    Time frame: At the beginning-at 12 weeks.

    The change of T before and after intervention

  3. Sex hormone-binding globulin (SHBG)

    Time frame: At the beginning-at 12 weeks.

    The change of SHBG before and after intervention

  4. Dehydroepiandrosterone sulphate (DHEA-S)

    Time frame: At the beginning-at 12 weeks.

    The change of DHEA-S before and after intervention

  5. Maximal oxygen uptake (VO2max)

    Time frame: At the beginning-at 12 weeks.

    The change of VO2max before and after intervention

  6. Body weight (BW)

    Time frame: At the beginning-at 12 weeks.

    The change of BW before and after intervention

  7. Height

    Time frame: At the beginning-at 12 weeks.

    The change of height before and after intervention

  8. Body mass index (BMI)

    Time frame: At the beginning-at 12 weeks.

    The change of BMI before and after intervention

Sponsors and collaborators

Lead sponsor

Beijing Sport University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2024
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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