NCT06445842

Brief Summary

The purpose of this graduate student research study is to provide healthcare professionals with evidence of the potential of circuit strength training in improving the physical and psychosocial well-being of postmenopausal women.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress97%
May 2024May 2026

Study Start

First participant enrolled

May 29, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

May 31, 2024

Last Update Submit

February 2, 2026

Conditions

Keywords

postmenopausalbalance

Outcome Measures

Primary Outcomes (2)

  • sleep quality

    The Pittsburgh Sleep Quality Index will be used to measure any trouble sleeping.

    change between baseline and eight weeks

  • IL-6 Biomarker

    Inflammatory biomarker IL-6 will be tested using a blood draw.

    change between baseline and eight weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

This group will perform exercises three times a week for eight weeks, with each session lasting approximately 45 minutes.

Other: Exercise

Non-Exercise Group

ACTIVE COMPARATOR

This group will maintain their sedentary lifestyle and will not make any changes to their diet or activity levels during this period

Other: No exercise

Interventions

The protocol involves a 10-minute warm-up and cool-down session, followed by two sets of high-intensity circuit training exercises (bench press, squats, overhead press, calf raising, barbell row, deadlifts) that last 12 minutes each (6 stations×2sets). There will be a 3-minute break between the exercise sets. The heart rate required during the exercise will be between 70-90% of their maximum capacity and a pre-scale rate of 7.5. The intensity of the exercise will be progressive each two weeks, commencing at 50% of their one rep max and increasing to 80% in their last week. During the initial phase, participants will be required to complete eight reps for each exercise. We will encourage them to increase their intensity level every two weeks.

Exercise Group

This group will need to maintain their sedentary lifestyle without changing their activity levels or diet

Non-Exercise Group

Eligibility Criteria

Age50 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsSelf-reported postmenopausal status
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females aged between 50 and 75 years.
  • Self-reported postmenopausal status (i.e., cessation of menstruation for a minimum of 12 months).
  • Physically capable of participating in an exercise intervention.
  • No engagement in structured resistance or aerobic training programs in the six months preceding the study.

You may not qualify if:

  • Classification as moderate and highly active on the International Physical Activity Questionnaire (IPAQ) (600-3000 MET-minutes/week for "moderate" and higher than 3000 MET-minutes/week for "high" score)
  • Diagnosis of any health condition that constitutes a contraindication to physical exercise (e.g., significant cardiovascular disease, orthopedic or neuromuscular restrictions impacting exercise performance or safety).
  • Regular use of medication with the potential to affect study outcomes (e.g., corticosteroids, immunosuppressants).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92354, United States

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Everett Lohman, DSc

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Everett Lohman, Dsc

CONTACT

Study Design

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

Study Record Dates

First Submitted

May 31, 2024

First Posted

June 6, 2024

Study Start

May 29, 2024

Primary Completion

May 1, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations