NCT05898503

Brief Summary

Brief Summary: The study was conducted in two parts, the first of which was carried out using a cross-sectional design approach to explore the relationship between cognitive function and autonomic function, brain function, inflammation and oxidative stress, vascular function, fitness levels, cardiorespiratory endurance and lipid metabolism. The second part uses a repeated measures design approach in a randomised controlled design to explore the effects of different types of exercise on cognitive decline in postmenopausal hypertensive women and their mechanisms of action.

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
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 23, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 12, 2023

Status Verified

April 1, 2023

Enrollment Period

1 year

First QC Date

April 20, 2023

Last Update Submit

June 1, 2023

Conditions

Cognitive FunctionHypertension

Keywords

Exercise interventionPostmenopausalCognitive functionHypertension

Outcome Measures

Primary Outcomes (1)

  • MOCA score

    The change of MOCA score. Montreal cognitive assessment (MoCA). The MoCA scale includes cognitive functions such as visuospatial and executive functions, naming, attention, language, abstraction, delayed recall and orientation, and evaluates the level of cognitive function from several cognitive dimensions. The MoCA has a total score of 30 questions, with 26 being normal and \<26 being cognitive decline.

    12 weeks

Secondary Outcomes (20)

  • Blood pressure

    12 weeks

  • Quiet heart rate

    12 weeks

  • Waist and hip circumference

    12 weeks

  • Body fat percentage

    12 weeks

  • Lipid metabolism indicators

    12 weeks

  • +15 more secondary outcomes

Study Arms (5)

Combined training group

EXPERIMENTAL
Behavioral: Walking exercise + resistance training

Resistance training group

EXPERIMENTAL
Behavioral: Resistance training

Walking exercise group

EXPERIMENTAL
Behavioral: Walking exercise

Positive control group

ACTIVE COMPARATOR
Behavioral: Health promotion

Negative control group

SHAM COMPARATOR
Behavioral: Health promotion

Interventions

Walking exercise + resistance trainingBEHAVIORAL

Walking exercise and resistance training for 12 weeks

Combined training group
Resistance trainingBEHAVIORAL

Resistance training for 12 weeks

Resistance training group
Walking exerciseBEHAVIORAL

Walking exercise for 12 weeks

Walking exercise group
Health promotionBEHAVIORAL

Health promotion for 12 weeks

Negative control groupPositive control group

Eligibility Criteria

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

You may not qualify if:

  • pre-menopausal, not falling under the above conditions 2 blood pressure not exceeding the above range 3 refractory hypertension and secondary hypertension 4 metabolic and cardiovascular diseases 5 unable to exercise for their own reasons 6 regular exercise (more than 6,000 steps per day) 7 poor lifestyle habits such as alcohol and smoking 8 suffering from cardiovascular disease risk classification of high or low
  • postmenopausal women aged 55 to 65 years
  • SBP ≥ 120 mmHg, DBP \< 90 mmHg
  • good physical condition
  • practice daily exercise (more than 6000 times daily)
  • do not drink or smoke
  • have a risk classification of no risk for cardiovascular disease
  • voluntary participation
  • pre-menopausal and not in the above category
  • SBP and DBP values below normal
  • general health, disability or other medical conditions
  • poor diet, alcohol abuse, smoking, etc.
  • no low risk cardiovascular risk classification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Resistance TrainingHealth Promotion

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

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

April 20, 2023

First Posted

June 12, 2023

Study Start

April 23, 2023

Primary Completion

April 23, 2024

Study Completion

December 31, 2024

Last Updated

June 12, 2023

Record last verified: 2023-04

Locations

CN(1)