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PostmenopausalNCT07131215

Smart Technology-Based Intervention and Monitoring of Physical and Mental Health in Early Postmenopausal Women

A study testing Home-based multimodal exercise, Supervised multimodal exercise program and Education in people with Postmenopausal and Postmenopausal Disorder, run by YI-JU TSAI at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The aim of this study is to compare the short-term and long-term effects of an 8-week home-based multimodal exercise program, delivered through a smartphone app, on quality of life, muscle function, and physical performance in early postmenopausal women. Read more about this study

Who is it for?
Ages 40 to 65 years, women only
Conditions the study is for
Postmenopausal, Postmenopausal Disorder, Menopause
What is being tested?
Home-based multimodal exercise, Supervised multimodal exercise program and Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTaiwan
Study dates
15 Aug 2025to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 45 to 65-year-old postmenopausal women
  • At least 12 months of amenorrhea
  • Within 6 years after menopause

Who cannot join

  • Exercised more than twice a week for at least 30 minutes per session
  • Received hormone therapy in the past three months
  • Neurological disease (e.g., spinal cord injury, multiple sclerosis, stroke) or cardiovascular diseases
  • History of pelvic or prolapse surgery (excluding cesarean section)
  • History of malignancy affecting the bladder, urethra, uterus, ovary, cervix, or rectum
  • Using medications that could affect heart rate or mood
  • Body mass index (BMI) > 35 kg/m²

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • National Cheng Kung University

    Tainan, 701

    Yi-Ju Tsai, Ph.D., +886 6 2353535 ext. 5021, yijutsai@mail.ncku.edu.tw

    Shih-Ting Lee, lish610216@gmail.com

    Recruiting

Other trials in Taiwan

About this study

The aim of this study is to compare the short-term and long-term effects of an 8-week home-based multimodal exercise program, delivered through a smartphone app, on quality of life, muscle function, and physical performance in early postmenopausal women.

Read the detailed description

The goal of this study is to investigate whether a comprehensive exercise program in early postmenopause can improve quality of life, physical function, and long-term health.

The main question it aims to answer is:

Does adding exercise intervention in early postmenopause will improve their quality of life and long-term health?

Being tested
Home-based multimodal exercise, Supervised multimodal exercise program, Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based multimodal exerciseOther

    Mobile Applications

  • Supervised multimodal exercise programOther

    In laboratory

  • EducationOther

    Menopause education

Study groups in NCT07131215
Study groupRoleWhat they receive
APP exercise groupExperimental8-week home-based multimodal exercise program via customized mobile APP
Receives: Other: Home-based multimodal exercise; Other: Education
Supervised exercise groupExperimental8-week supervised exercise program in the laboratory
Receives: Other: Supervised multimodal exercise program; Other: Education
Education control groupOther30-minute educational session
Receives: Other: Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle function measures for lumbopelvic muscle: Abdominal and back muscles

    Ultrasonography images of muscle thickness of abdominal and back muscles during rest and during active straight leg raise. Each condition will be tested three times. Muscle thickness at rest and during contraction will be measured using ImageJ, with results expressed in millimeters (mm)

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  2. Muscle function measures for lumbopelvic muscle

    Ultrasonography images of bladder displacement for pelvic floor muscles during rest, maximum contraction, and during active straight leg raise. Each condition will be tested three times. Bladder height differences between contraction and relaxation of the pelvic floor muscles will be measured using ImageJ, with results expressed in millimeters (mm).

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  3. Functional performance of Supine isometric chest lift test

    The Supine Isometric Chest Lift Test will be used to assess the endurance of the abdominal muscles. Participants lie in a supine position and are instructed to lift the head and shoulders off the floor, maintaining the isometric position as long as possible. The holding time is recorded in seconds

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  4. Functional performance of Double Straight-Leg Raise Test

    The Double Straight-Leg Raise Test will be used to assess the endurance of the trunk flexor muscles. Participants lie supine and are instructed to raise both legs to approximately 45 degrees and maintain this position as long as possible. The holding time is recorded in seconds

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  5. Functional performance of sorensen test

    The Sorensen test will be used to assess the endurance of the back extensor muscles. Participants lie prone with the upper body extended beyond the edge of a table and are instructed to maintain a horizontal trunk position as long as possible. The total holding time is recorded in seconds

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  6. Functional performance of Active straight-leg raise fatigue task

    Participants lifted the heel of the test leg to 20 cm for as long as possible. Participants were required to maintain pressure in the cuff beneath their back as close to 40 mm Hg as possible. Visual feedback of cuff pressure was provided throughout the task, but no instruction was given on how to affect cuff pressure. Task failure was defi ned as an inability to maintain heel height 10 cm or more off the plinth and/or a change in cuff pressure of 20 mm Hg or more.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  7. Endurance of the pelvic stabilizing muscles

    The manometry will provide measurements of pelvic floor muscle (PFM) function, including peak contraction pressure, average contraction pressure, and endurance capacity.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  8. Functional performance of timed up and go test

    Test instructions were given in Norwegian. Translated into English, the instructions were as follows: 'After "ready, set, go" stand up, walk as fast as you can until you cross the white line, turn around, and walk back to the chair and sit down again'. The white line was positioned 3m from the patient's starting position.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  9. Functional performance of 6-Meter Walk Test

    Subjects commenced the test in standing with their toes up against the tape marker. Test instructions translated into English were as follows: 'After "ready, set, go", walk as fast as you can up to the last white line without stopping or speaking along the way'. Performances were timed (to the nearest 100th of a second) between the 2m and 8m markers and later converted into speed in metres per second.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  10. Functional performance of Four-Square Step Test

    The Four-Square Step Test (FSST) will be used to assess dynamic balance and mobility. Participants are required to step rapidly in a specific sequence across four squares. The total time to complete the sequence is recorded in seconds.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  11. Functional performance of Single-Leg Stance Test

    The Single-Leg Stance Test (SLST) will be used to assess static balance. Participants stand unassisted on one leg for as long as possible, with the test terminated when balance is lost or the non-supporting foot touches the ground. The holding time is recorded in seconds

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  12. Body composition

    The InBody 770 bioelectrical impedance analysis (BIA) system will provide measurements of skeletal muscle mass (kg), lean body mass (kg), and total body water (L)

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  13. Body composition and bone mineral density

    The dual-energy X-ray absorptiometry (DXA) system will provide measurements of bone mineral density (BMD) at the lumbar spine and hip regions (g/cm²)

    Measured: Changes from baseline to 8 weeks when participants finish the intervention.

  14. Effectiveness of the app:System Usability Scale (SUS)

    The System Usability Scale (SUS) will be used to evaluate the usability and user satisfaction of the system. The total score is converted to a 0-100 scale, where 0 represents the lowest usability and 100 represents the highest usability. Higher scores indicate better usability

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  15. Effectiveness of the app:Patient Satisfaction and Usability with Apps Questionnaire

    The Patient Satisfaction and Usability with Apps Questionnaire (pSUAPP) will be used to evaluate participants' satisfaction and perceived usability of the mobile health application. The total score ranges from 28 to 140 . Higher total scores indicate better user experience and app functionality

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  16. Self-perceived Change:Global Rating of Change Scale (GROC)

    The Global Rating of Change Scale (GROC) rates perceived "overall change" on a 15-point Likert scale, with 7 (labeled "worse") on the left, +7 (labeled "better") on the right, and 0 in the middle (labeled "no change") compared to the baseline.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  17. Quality of life and menopause related questionnaire:Brief Pain Inventory (BPI)

    The Brief Pain Inventory (BPI) will be used to assess overall pain intensity and pain-related interference with daily activities. Each item is scored on a 0-10 scale.Higher scores represent worse outcomes.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  18. Menopause related questionnaire:Menopause-Specific Quality of Life Questionnaire (MENQOL)

    The Menopause-Specific Quality of Life Questionnaire (MENQOL) will provide domain-specific and overall scores assessing the impact of menopause on quality of life. The total score ranges from 0 to 174, with higher scores indicating worse symptoms and a greater negative impact on quality of life.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  19. Quality of life and menopause related questionnaire:International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)

    The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) will provide a total score (0-21) to evaluate the severity of urinary incontinence and its impact on quality of life, with higher scores indicating greater symptom severity.

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  20. Quality of life and menopause related questionnaire:Incontinence Quality of Life (I-QoL)

    The Incontinence Quality of Life (I-QoL) questionnaire will assess quality of life related to urinary incontinence. Scores are transformed to a 0-100 scale. Higher scores indicate better incontinence-related quality of life

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

  21. Quality of life and menopause related questionnaire:International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    The International Physical Activity Questionnaire-Short Form (IPAQ-SF) will be used to assess physical activity levels over the past 7 days

    Measured: Changes from baseline to 8 weeks when participants finish the intervention, and follow-up assessments at 3 and 6 months post-intervention.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2025
  2. Study start15 Aug 2025
  3. Primary completion30 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07131215
Sponsor's protocol ID
NCKU_Postmenopausal
Status last verified
Apr 2026
First submitted
20 Jul 2025
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Home-based multimodal exercise, Supervised multimodal exercise program and Education in people with Postmenopausal and Postmenopausal Disorder, run by YI-JU TSAI at 1 site in Taiwan.

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 7 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: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi-Ju Tsai PhD (+886-6-2353535 Ext. 5021, yijutsai@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle function measures for lumbopelvic muscle: Abdominal and back muscles (time frame: Changes from baseline to 8 weeks when participants finish the intervention.). The study lists 21 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 14 Apr 2026.

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