Smart Technology-Based Intervention and Monitoring of Physical and Mental Health in Early Postmenopausal Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-65
SponsorYI-JU TSAI
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
45 to 65-year-old postmenopausal women
At least 12 months of amenorrhea
Within 6 years after menopause
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based multimodal exercise
Other interventionMobile Applications
Supervised multimodal exercise program
Other interventionIn laboratory
Education
Other interventionMenopause education
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: APP exercise groupExperimental treatment 2 interventions
Group B: Supervised exercise groupExperimental treatment 2 interventions
Group C: Education control groupOther 1 intervention
Trial outcomes
Primary outcomes
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)
Time frame
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).
Time frame
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
Time frame
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
Time frame
Changes from baseline to 8 weeks when participants finish the intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
YI-JU TSAI
Lead sponsor
National Cheng Kung University
Sponsor institution
Source ClinicalTrials.gov