NCT06958965

Brief Summary

Postmenopausal women often face risks of vascular dysfunction and muscle deterioration due to estrogen deficiency. These changes significantly increase the risk of cardiovascular disease and mortality. Previous studies have shown a significant positive correlation between vascular endothelial function and muscle strength. Moreover, muscle strength is a stronger predictor of mortality than muscle mass and is closely associated with the maintenance of functional independence in daily life. However, studies investigating the effects of whole-body progressive resistance training on vascular function and physical performance in postmenopausal women remain limited. This study aims to examine changes in vascular function and muscle strength in postmenopausal women following a whole-body progressive resistance training program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 6, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

June 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2025

Completed
Last Updated

March 13, 2026

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

April 28, 2025

Last Update Submit

March 12, 2026

Conditions

Keywords

exercisecardiovascular diseasesarteriesarterial compliancehormonesestrogen

Outcome Measures

Primary Outcomes (2)

  • Flow-mediated dilation-endothelial function

    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.

    Change from baseline at 12 weeks

  • Brachial-ankle plus wave velocity (baPWV)-arterial stiffness

    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

Secondary Outcomes (8)

  • Hand grip strength- muscle strength

    Change from baseline at 12 weeks

  • Five-repetition maximum test (5RM)

    Change from baseline at 12 weeks

  • Body Composition

    Change from baseline at 12 weeks

  • Perceived Exertion

    Change from baseline at 12 weeks

  • International Physical Activity Questionnaire (IPAQ) - Taiwan Physical Activity Questionnaire (Short Form)

    Change from baseline at 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

Effects of Resistance Exercise Training on Vascular Function and Physical Performance in Postmenopau

EXPERIMENTAL

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.

Other: Resistance exercise training

Control

NO INTERVENTION

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.

Interventions

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).

Also known as: resistance training
Effects of Resistance Exercise Training on Vascular Function and Physical Performance in Postmenopau

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 112304, Taiwan

Location

MeSH Terms

Conditions

Motor ActivityCardiovascular Diseases

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2025

First Posted

May 6, 2025

Study Start

June 9, 2025

Primary Completion

November 3, 2025

Study Completion

November 3, 2025

Last Updated

March 13, 2026

Record last verified: 2025-07

Locations