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

NCT07131215 | Recruiting

• 1 other identifier: NCKU_Postmenopausal
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postmenopausal Disorder; Menopause; Postmenopausal

Outcome Measures

Primary Outcomes (21)

• 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)

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

• 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).

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

• 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

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

• 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

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

• 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

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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

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

• 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)

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

• 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)

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

• 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

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

• 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

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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

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

• 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

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

Study Arms (3)

APP exercise group

EXPERIMENTAL

8-week home-based multimodal exercise program via customized mobile APP

Other: Home-based multimodal exercise; Other: Education

Supervised exercise group

EXPERIMENTAL

8-week supervised exercise program in the laboratory

Other: Supervised multimodal exercise program; Other: Education

Education control group

OTHER

30-minute educational session

Other: Education

Interventions

Supervised multimodal exercise program OTHER

In laboratory

Supervised exercise group

Home-based multimodal exercise OTHER

Mobile Applications

APP exercise group

Education OTHER

Menopause education

APP exercise group; Education control group; Supervised exercise group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• YI-JU TSAI: lead

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

RECRUITING

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Yi-Ju Tsai PhD

CONTACT

+886-6-2353535 Ext. 5021; yijutsai@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: August 20, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

TW (1)