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

Not Applicable

Completed

• Conditions: Postmenopause Women
• Interventions: Behavioral: Maintained lifestyle; Behavioral: Fitness walking

• Registration Number: NCT06454032
• Lead Sponsor: Beijing Sport University

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.

Study Timeline

• Study Start: 2022-04-16
• Primary Completion: 2022-09-30
• Study Completion: 2022-12-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Last Update Submitted: 2024-06-06
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Maintained lifestyle	-
Fitness walking group	Fitness walking	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

School of Sports Medicine and Rehabilitation, Beijing Sport University; 🇨🇳 Beijing, China

School of Sports Medicine and Rehabilitation; 🇨🇳 Beijing, China