NCT06454032

Brief Summary

Postmenopausal women were separated into two groups: one participating in a 12-week fitness walking programe as the fitness walking group, and the other maintaining their regular lifestyle as the control group. The study evaluated alterations in health markers and examined the correlation between metabolic syndrome risk factors and sex hormone levels before and after the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

April 16, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

June 6, 2024

Last Update Submit

June 6, 2024

Conditions

Postmenopause Women

Keywords

ExercisePostmenopauseWomen's healthMetabolismSex hormone

Outcome Measures

Primary Outcomes (6)

  • Systolic blood pressure (SBP)

    The change of SBP before and after intervention

    At the beginning-at 12 weeks.

  • Diastolic blood pressure (DBP)

    The change of DBP before and after intervention

    At the beginning-at 12 weeks.

  • Waist circumference (WC)

    The change of WC before and after intervention

    At the beginning-at 12 weeks.

  • Fasting blood glucose (FBG)

    The change of FBG before and after intervention

    At the beginning-at 12 weeks.

  • Triglycerides (TG)

    The change of TG before and after intervention

    At the beginning-at 12 weeks.

  • High-density lipoprotein cholesterol (HDL-C)

    The change of HDL-C before and after intervention

    At the beginning-at 12 weeks.

Secondary Outcomes (8)

  • Oestradiol (E2)

    At the beginning-at 12 weeks.

  • Testosterone (T)

    At the beginning-at 12 weeks.

  • Sex hormone-binding globulin (SHBG)

    At the beginning-at 12 weeks.

  • Dehydroepiandrosterone sulphate (DHEA-S)

    At the beginning-at 12 weeks.

  • Maximal oxygen uptake (VO2max)

    At the beginning-at 12 weeks.

  • +3 more secondary outcomes

Study Arms (2)

Fitness walking group

EXPERIMENTAL
Behavioral: Fitness walking

Control group

SHAM COMPARATOR
Behavioral: Maintained lifestyle

Interventions

Fitness walkingBEHAVIORAL

Fitness walking for 12 weeks.

Fitness walking group
Maintained lifestyleBEHAVIORAL

Maintained their normal lifestyle, without exercise intervention.

Control group

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (1) Participants were entirely voluntary and capable of completing the full 12-week intervention process.
  • (2) Participants were postmenopausal women aged between 50 and 69 years.
  • (3) Participants had been postmenopausal for over 12 months and had not received exogenous estrogen supplementation post-menopause.

You may not qualify if:

  • (1) Participants had a history of acute or chronic musculoskeletal disorders, cardiovascular diseases, diabetes, or other conditions that might impact their ability to engage in the intervention.
  • (2) Participants had recent hormone treatment, anti-inflammatory medication use, or other medications affecting blood indices.
  • (3) Participants experienced unstable body weight (fluctuations exceeding 2.5 kg) in the past three months.
  • (4) Participants were concurrently enrolled in other intervention studies or maintained regular exercise routines.
  • (5) Participants had smoking or alcohol consumption habits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

School of Sports Medicine and Rehabilitation, Beijing Sport University

Beijing, China

Location

School of Sports Medicine and Rehabilitation

Beijing, China

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

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

Study Record Dates

First Submitted

June 6, 2024

First Posted

June 12, 2024

Study Start

April 16, 2022

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

June 12, 2024

Record last verified: 2024-06

Locations

CN(2)