Clinical trial NCT06454032: Effect of 12-week FW Programme on Sex Hormone Levels and Risk Factors for MS in Postmenopausal Women
Official title: Effect of 12-week Fitness Walking Programme on Sex Hormone Levels and Risk Factors for Metabolic Syndrome in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopause Women
Keywords: Exercise
Postmenopause
Women's health
Metabolism
Sex hormone
Lead sponsor: Beijing Sport University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Systolic blood pressure (SBP)
timeFrame: At the beginning-at 12 weeks.
measure: Diastolic blood pressure (DBP)
timeFrame: At the beginning-at 12 weeks.
measure: Waist circumference (WC)
timeFrame: At the beginning-at 12 weeks.
measure: Fasting blood glucose (FBG)
timeFrame: At the beginning-at 12 weeks.
measure: Triglycerides (TG)
timeFrame: At the beginning-at 12 weeks.
measure: High-density lipoprotein cholesterol (HDL-C)
timeFrame: At the beginning-at 12 weeks.
Secondary outcomes:
measure: Oestradiol (E2)
timeFrame: At the beginning-at 12 weeks.
measure: Testosterone (T)
timeFrame: At the beginning-at 12 weeks.
measure: Sex hormone-binding globulin (SHBG)
timeFrame: At the beginning-at 12 weeks.
measure: Dehydroepiandrosterone sulphate (DHEA-S)
timeFrame: At the beginning-at 12 weeks.
measure: Maximal oxygen uptake (VO2max)
timeFrame: At the beginning-at 12 weeks.
measure: Body weight (BW)
timeFrame: At the beginning-at 12 weeks.
measure: Height
timeFrame: At the beginning-at 12 weeks.
measure: Body mass index (BMI)
timeFrame: At the beginning-at 12 weeks.
Other outcomes:
Locations:
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation, Beijing Sport University
city: Beijing
country: China
facility: School of Sports Medicine and Rehabilitation
Study officials:
References: