- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06958965
- Original Trial
Resistance Exercise Training on Vascular and Physical Function in Postmenopausal Women
Effects of Resistance Exercise Training on Vascular Function and Physical Performance in Postmenopausal Women
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taipei, Taiwan, 112304
- National Yang Ming Chiao Tung University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants were eligible for the study if they met the following criteria:
- Postmenopausal women aged between 55 and 70 years;
- Body mass index (BMI) less than 30 kg/m²;
- At least one year since menopause;
- Able to live independently in the community;
- Able to communicate independently in Mandarin or Taiwanese.
Exclusion Criteria:
Participants were excluded if they met any of the following conditions:
- Acute musculoskeletal injuries within the past month (e.g., acute inflammation, fractures, sprains, contusions, or joint implants);
- Diagnosed central or peripheral nervous system disorders affecting exercise participation (e.g., stroke, dementia, Parkinson's disease, autonomic dysfunction);
- History of serious cardiac conditions within the past six months (e.g., coronary stenting, pacemaker implantation, peripheral or cerebral vascular reconstruction);
- Presence of peripheral vascular diseases (e.g., peripheral artery disease, venous thrombosis);
- Hormone therapy within the past six months;
- Currently taking beta-blockers, anti-inflammatory drugs, or anticoagulant medications;
- Currently participating in any other structured exercise training programs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Effects of Resistance Exercise Training on Vascular Function and Physical Performance in Postmenopau
This study involved a 12-week group-based resistance training program, with two sessions per week, each lasting 90 to 120 minutes.
The exercise intensity targeted 40-70% of participants' one-repetition maximum (1RM) or a moderate level (approximately a score of 3 on the Modified Borg RPE scale).
Equipment used included dumbbells, kettlebells, grip rings, body bars, resistance bands, step platforms, and sandbags, following a three-phase structured exercise model.
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The total duration of the training was 12 weeks, with a frequency of two sessions per week.
Each session lasted approximately 90 to 120 minutes.
The exercise intensity was set at 40-70% of the participants' one-repetition maximum (1RM), or adjusted based on the Modified Borg Rating of Perceived Exertion (RPE), targeting a moderate intensity level (approximately a score of 3).
Other Names:
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No Intervention: Control
Participants in the control group did not undergo any resistance training intervention and were advised to continue their usual daily routines, dietary patterns, and prescribed medications throughout the study period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Flow-mediated dilation-endothelial function
Time Frame: Change from baseline at 12 weeks
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During the test, participants were instructed to remain in a supine position with the shoulder abducted to 90 degrees and the palm facing upward.
A friction-reducing sleeve and a sphygmomanometer cuff were placed on the distal part of the non-dominant forearm.
The cuff inflation pressure was set at least 50 mmHg above the systolic blood pressure measured from the dominant arm and maintained for 5 minutes.
Immediately after the 5-minute occlusion period, the cuff was rapidly deflated, and the brachial artery diameter was continuously monitored for up to 3 minutes to capture post-deflation vascular changes.
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Change from baseline at 12 weeks
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Brachial-ankle plus wave velocity (baPWV)-arterial stiffness
Time Frame: Chang from baseline at 12 weeks
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A non-invasive assessment of arterial stiffness was conducted using an arterial stiffness device based on pulse wave velocity (PWV) measurement. During the test, participants were instructed to lie in a relaxed supine position in a quiet environment. Four blood pressure cuffs were placed on both arms and both ankles. The measurements from the left and right sides were averaged for analysis.The PWV was calculated using the following formula: PWV = Distance / Pulse Transit Time |
Chang from baseline at 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hand grip strength- muscle strength
Time Frame: Change from baseline at 12 weeks
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Participants were instructed to stand with their feet shoulder-width apart, with elbows fully extended and slightly abducted at approximately 45 degrees.
They were asked to apply maximum grip strength and hold for 3 to 4 seconds.
Each hand was tested three times, with a 10- to 15-second rest between trials.
Both hands were tested, and the highest value from each hand was recorded for analysis.
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Change from baseline at 12 weeks
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Five-repetition maximum test (5RM)
Time Frame: Change from baseline at 12 weeks
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In this study, exercise intensity was estimated using the five-repetition maximum (5RM) test to predict the one-repetition maximum (1RM). Given that the target population consisted of middle-aged and older postmenopausal women, the 5RM test was selected to reduce the risk of injury and enhance participant motivation. The predicted 1RM was calculated using the formula proposed by LeSuer et al.: 1RM = body weight × (1 + 0.0333 × number of repetitions) |
Change from baseline at 12 weeks
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Body Composition
Time Frame: Change from baseline at 12 weeks
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Skeletal muscle mass index (SMI) of the limbs was assessed using multifrequency bioelectrical impedance analysis (MF-BIA; InBody 270, Tokyo, Japan).
During the test, participants stood barefoot on the marked footplate positions with their arms relaxed and slightly abducted, placing their thumbs on the designated sensors.
Each measurement lasted approximately 10 to 15 seconds while maintaining a standing posture.
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Change from baseline at 12 weeks
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Perceived Exertion
Time Frame: Change from baseline at 12 weeks
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This study utilized the Chinese version of the Modified Borg Rating of Perceived Exertion (RPE) scale to assess participants' subjective perception of effort.
The scale ranges from 0 to 10, where a score of 0 indicates no exertion at all.
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Change from baseline at 12 weeks
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International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form)
Time Frame: Change from baseline at 12 weeks
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The IPAQ is a self-reported instrument assesses the time spent in the past 7 days on activities including work, housework, gardening/balcony work, commuting, leisure, and exercise.
Total time spent per week is multiplied by the metabolic equivalent (MET) and summed to present the total MET-minutes per week.
Physical activity intensity is classified into walking (3.3 METs), moderate (4.0 METs), and vigorous (8.0 METs).
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Change from baseline at 12 weeks
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Short Physical Performance Battery (SPPB)
Time Frame: Change from baseline at 12 weeks
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This assessment consisted of three components to evaluate lower extremity function.
First, the standing balance test required participants to maintain balance in three stances-feet together, semi-tandem, and full tandem-for up to 10 seconds each.
Second, the gait speed test measured the time it took participants to walk 4 meters at their usual pace, reflecting their walking speed.
Third, the chair stand test assessed lower limb muscle strength by recording the time needed to complete five consecutive sit-to-stand movements with arms crossed over the chest.
These tests collectively provided an objective measure of physical performance.
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Change from baseline at 12 weeks
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3-Meter Walk Test
Time Frame: Change from baseline at 12 weeks
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This test is used to assess lower limb strength, balance, gait, and functional mobility in older adults.
At the start of the test, the participant sits on a chair with a backrest, placing both hands on their thighs.
Upon instruction, the participant stands up, walks to a marker placed 3 meters away, turns around the marker, walks back, and sits down again.
The test is performed at the fastest safe speed.
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Change from baseline at 12 weeks
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30-Second Chair Stand Test:
Time Frame: Change from baseline at 12 weeks
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While seated on a chair of standard height with feet flat on the floor, participants are instructed to cross their arms over their chest.
Upon the start of the test, they repeatedly stand up and sit down as many times as possible within 30 seconds.
The total number of completed repetitions is recorded.
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Change from baseline at 12 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavior
- Cardiovascular Diseases
- Motor Activity
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Therapeutics
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Physical Conditioning, Human
- Exercise
- Resistance Training
Other Study ID Numbers
- NYCU114053AE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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