NCT06201312

Brief Summary

Recruit postmenopausal women and randomly assign them to one of four groups: Early Postmenopausal Exercise Group (EE), Late Postmenopausal Exercise Group (LE), Early Postmenopausal Control Group (EC), and Late Postmenopausal Control Group (LC). All participates will undergo a graded exercise test to determine their maximum oxygen uptake, and vascular function response will be measured immediately after the exercise test. The COP exercise intensity for postmenopausal women will be obtained through the exercise test, and subjects in the EE and LE groups will undergo exercise training at this intensity for a period of three months. Tests and analyses of relevant indicators will be conducted on subjects in all four groups before and after the intervention. The exercise load experiments will be performed on a cycle ergometer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 11, 2024

Status Verified

December 1, 2023

Enrollment Period

10 months

First QC Date

December 7, 2023

Last Update Submit

January 10, 2024

Conditions

Vascular Health

Keywords

vascular healthcrossover point

Outcome Measures

Primary Outcomes (9)

  • Brachial Artery Flow-Mediated Dilation

    The changes in brachial artery flow-mediated dilation are assessed at three time points: before the intervention, after the acute exercise, and three months following the intervention.

    12 weeks

  • Carotid Intima-Media Thickness

    The change of Carotid Intima-Media Thickness before and after intervention.

    12 weeks

  • Carotid Diameter

    The change of Carotid Diameter before and after intervention.

    12 weeks

  • Carotid End-Diastolic Velocity

    The change of Carotid End-Diastolic Velocity before and after intervention.

    12 weeks

  • Carotid Peak Systolic Velocity

    The change of Carotid Peak Systolic Velocity before and after intervention.

    12 weeks

  • Pulsatility Index

    The change of Pulsatility Index before and after intervention.

    12 weeks

  • Resistive Index

    The change of Resistive Index before and after intervention

    12 weeks

  • Brachial-Ankle Pulse Wave Velocity

    The change of Brachial-Ankle Pulse Wave Velocity before and after intervention.

    12 weeks

  • Ankle-Brachial Index

    The change of Ankle-Brachial Index before and after intervention.

    12 weeks

Secondary Outcomes (43)

  • Serum Nitric Oxide level

    12 weeks

  • Plasma Nitrate level

    12 weeks

  • ERRα mRNA and Protein Expression level

    12 weeks

  • PGC1α mRNA Expression level

    12 weeks

  • PGC1α Protein Expression level

    12 weeks

  • +38 more secondary outcomes

Study Arms (4)

Early Postmenopausal Exercise Group (EE)

EXPERIMENTAL
Other: COP exercise

Late Postmenopausal Exercise Group (LE)

EXPERIMENTAL
Other: COP exercise

Early Postmenopausal Control Group (EC)

NO INTERVENTION

Late Postmenopausal Control Group (LC)

NO INTERVENTION

Interventions

COP exerciseOTHER

crossover point intensity exercise

Early Postmenopausal Exercise Group (EE)Late Postmenopausal Exercise Group (LE)

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women without cardiovascular disease

You may not qualify if:

  • Women with undetermined menopause
  • BMI \<18.5 kg/m2 or BMI \>28 kg/m2
  • fasting plasma triglyceride levels ≥500 mgdl
  • diabetes mellitus or fasting glucose \>140 mgd
  • blood creatinine \>2.0 mgdl
  • uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>110 mmHg)
  • untreated thyroid disease
  • life-threatening illness with a prognosis of \<5 years;
  • history of deep vein thrombosis,
  • pulmonary embolism, or breast cancer;
  • currently receiving estrogen therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, China

RECRUITING

Central Study Contacts

Peizhen Zhang

CONTACT

01062989581zhpzh@bsu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2023

First Posted

January 11, 2024

Study Start

December 11, 2023

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

January 11, 2024

Record last verified: 2023-12

Locations

CN(1)