Postmenopause WomenNCT06454032
Effect of 12-week FW Programme on Sex Hormone Levels and Risk Factors for MS in Postmenopausal Women
A study testing Fitness walking and Maintained lifestyle in people with Postmenopause Women, run by Beijing Sport University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopause Women
- What is being tested?
- Fitness walking and Maintained lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 16 Apr 2022to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
School of Sports Medicine and Rehabilitation, Beijing Sport University
Beijing
School of Sports Medicine and Rehabilitation
Beijing
About this study
Official title: 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.
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.
- Conditions
- Postmenopause Women
- Being tested
- Fitness walking, Maintained lifestyle
- Keywords
- Exercise, Postmenopause, Women's health, Metabolism, Sex hormone
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness walkingBehavioural
Fitness walking for 12 weeks.
Maintained lifestyleBehavioural
Maintained their normal lifestyle, without exercise intervention.
| Study group | Role | What they receive |
|---|---|---|
| Fitness walking group | Experimental | Not described Receives: Behavioral: Fitness walking |
| Control group | Sham comparator | Not described Receives: Behavioral: Maintained lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure (SBP)
The change of SBP before and after intervention
Measured: At the beginning-at 12 weeks.
Diastolic blood pressure (DBP)
The change of DBP before and after intervention
Measured: At the beginning-at 12 weeks.
Waist circumference (WC)
The change of WC before and after intervention
Measured: At the beginning-at 12 weeks.
Fasting blood glucose (FBG)
The change of FBG before and after intervention
Measured: At the beginning-at 12 weeks.
Triglycerides (TG)
The change of TG before and after intervention
Measured: At the beginning-at 12 weeks.
High-density lipoprotein cholesterol (HDL-C)
The change of HDL-C before and after intervention
Measured: At the beginning-at 12 weeks.
Secondary outcomes (8)
Oestradiol (E2)
The change of E2 before and after intervention
Measured: At the beginning-at 12 weeks.
Testosterone (T)
The change of T before and after intervention
Measured: At the beginning-at 12 weeks.
Sex hormone-binding globulin (SHBG)
The change of SHBG before and after intervention
Measured: At the beginning-at 12 weeks.
Dehydroepiandrosterone sulphate (DHEA-S)
The change of DHEA-S before and after intervention
Measured: At the beginning-at 12 weeks.
Maximal oxygen uptake (VO2max)
The change of VO2max before and after intervention
Measured: At the beginning-at 12 weeks.
Body weight (BW)
The change of BW before and after intervention
Measured: At the beginning-at 12 weeks.
Height
The change of height before and after intervention
Measured: At the beginning-at 12 weeks.
Body mass index (BMI)
The change of BMI before and after intervention
Measured: At the beginning-at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start16 Apr 2022
- Primary completion30 Sep 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopause WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Sport University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454032
- Sponsor's protocol ID
- EOFWOSHLARFMSIPP
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 12-week Fitness Walking Programme on Sex Hormone Levels and Risk Factors for Metabolic Syndrome in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT06454032
- Acronym / sponsor ID
- EOFWOSHLARFMSIPP
- Conditions
- Postmenopause Women
- Keywords
- Exercise, Postmenopause, Women's health, Metabolism, Sex hormone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Beijing Sport UniversityUniversity, hospital or other
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitness walking group | Experimental | Behavioral: Fitness walking |
| Control group | Sham comparator | Behavioral: Maintained lifestyle |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- (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.
Key exclusion criteria (5 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness walkingFitness walking for 12 weeks. | Behavioural | Fitness walking group |
| Maintained lifestyleMaintained their normal lifestyle, without exercise intervention. | Behavioural | Control group |
Primary outcome
Systolic blood pressure (SBP)
Time frame: At the beginning-at 12 weeks.
The change of SBP before and after intervention
Diastolic blood pressure (DBP)
Time frame: At the beginning-at 12 weeks.
The change of DBP before and after intervention
Waist circumference (WC)
Time frame: At the beginning-at 12 weeks.
The change of WC before and after intervention
Fasting blood glucose (FBG)
Time frame: At the beginning-at 12 weeks.
The change of FBG before and after intervention
Triglycerides (TG)
Time frame: At the beginning-at 12 weeks.
The change of TG before and after intervention
High-density lipoprotein cholesterol (HDL-C)
Time frame: At the beginning-at 12 weeks.
The change of HDL-C before and after intervention
8 secondary outcomes
Oestradiol (E2)
Time frame: At the beginning-at 12 weeks.
Testosterone (T)
Time frame: At the beginning-at 12 weeks.
Sex hormone-binding globulin (SHBG)
Time frame: At the beginning-at 12 weeks.
Dehydroepiandrosterone sulphate (DHEA-S)
Time frame: At the beginning-at 12 weeks.
Maximal oxygen uptake (VO2max)
Time frame: At the beginning-at 12 weeks.
Body weight (BW)
Time frame: At the beginning-at 12 weeks.
Height
Time frame: At the beginning-at 12 weeks.
Body mass index (BMI)
Time frame: At the beginning-at 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
Related trials for Postmenopause Women
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Recruiting
Hop Extract Versus Soy Isoflavone Extract for Menopausal Symptoms (HOPES)
Menopause, Perimenopause
Not yet recruiting
The Role of Diet Quality in Sleep Among Women in Postmenopause
Post Menopausal Women
Not yet recruitingObservational study
Serum Estradiol and Endometrial Thickness After Bariatric Surgery in Postmenopausal Women With Obesity
Obesity, Morbid, Postmenopause
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness walking and Maintained lifestyle in people with Postmenopause Women, run by Beijing Sport University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (SBP) (time frame: At the beginning-at 12 weeks.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.