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Recruiting NCT07131215

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

No phase Interventional Postmenopausal Postmenopausal Disorder Menopause

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home-based multimodal exercise, Supervised multimodal exercise program, Education.
Who it may be relevant to
Registry conditions: Postmenopausal, Postmenopausal Disorder, Menopause. Basic parameters: 40 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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?

Interventions

  • Other Home-based multimodal exercise
    Mobile Applications
  • Other Supervised multimodal exercise program
    In laboratory
  • Other Education
    Menopause education

Primary outcome measures

  • Muscle function measures for lumbopelvic muscle: Abdominal and back muscles [Time frame: Changes from baseline to 8 weeks when participants finish the intervention.]
  • Muscle function measures for lumbopelvic muscle [Time frame: Changes from baseline to 8 weeks when participants finish the intervention.]
  • Functional performance of Supine isometric chest lift test [Time frame: Changes from baseline to 8 weeks when participants finish the intervention.]
  • Functional performance of Double Straight-Leg Raise Test [Time frame: Changes from baseline to 8 weeks when participants finish the intervention.]
  • Functional performance of sorensen test [Time frame: Changes from baseline to 8 weeks when participants finish the intervention.]
  • Functional performance of Active straight-leg raise fatigue task [Time frame: Changes from baseline to 8 weeks when participants finish the intervention.]
  • Endurance of the pelvic stabilizing muscles [Time frame: Changes from baseline to 8 weeks when participants finish the intervention.]
  • Functional performance of timed up and go test [Time frame: 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 [Time frame: 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 [Time frame: Changes from baseline to 8 weeks when participants finish the intervention.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Cheng Kung University — Tainan

Identifiers

NCT: NCT07131215 · NCKU_Postmenopausal

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗