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NCT Number: NCT06445842

Short-term Circuit Training on Muscle Mass and Quality of Life in Sedentary Postmenopausal Women

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.

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Key information

Conditions

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92354, United States

Location status: Recruiting

Location contact

Everett Lohman, DSc

CONTACT

[email protected]

909-558-1000 ext. 83171

About this study

A randomized controlled trial design will investigate the effects of circuit training on the following dependent variables: muscle mass, strength, inflammatory markers, balance, functional capacity, and quality of life.

Body composition measurements will utilize IN-BODY technology. The Motor Control Screen Lower Body (MCS) will determine balance. For assessing strength, we will use the Dynamometer, specifically for grip strength. Ultrasound will gauge muscle mass, while the BTE (Baltimore Therapeutic Equipment) will handle quadriceps isometric muscle tests. The Peak Expiratory Flow (PEF) will evaluate respiratory strength. Participants' aerobic capacity will be gauged via the 6-minute Walk Test. Heart Rate Variability (HRV) evaluations will rely on Polar devices, and the Fitbit Inspire3. We will also employ the Fitbit Inspire3for tracking sleep quality. Psychosocial factors will be examined through: Falls Efficacy Scale-International (FES-I), SF-36 QOL Questionnaire, PHQ-ADS, and the Pittsburgh Sleep Quality Index (PSQI). Activity levels will be determined through the IPAQ-SF questionnaire. The questionnaires will be completed on Qualtrics or in hardcopy format. Blood tests will monitor inflammatory markers such as IL-6, TNF-α, and hs-CRP. The study will be conducted over 10 weeks, starting from the initial and final data collection. During the first week, participants will need to visit the research laboratory to undergo basic tests. After completing all procedures, including informed consent and blood collection, participants will be randomly assigned (computerized generated) to the experimental (exercise) group (N=18) or control (non-exercise) group (N=18).

In the first week, the exercise group will participate for two additional days to introduce the exercise, evaluate their movements, and determine their maximum exercise capacity. The experimental group will participate in circuit strength training sessions lasting approximately 45 minutes three times a week for 8 weeks. The exercise protocol will consist of a 10-minute warm-up and cool-down, two sets of 12-minute high-intensity circuit training exercises, and a 3-minute break between sets. The intensity of the exercises will be gradually increased every two weeks for 8 weeks.

Meanwhile, the control group will need to maintain their sedentary lifestyle without changing their activity levels or diet.

After completing the 8-week exercise protocol, all participants will visit the lab for a second round of data collection. Additionally, the exercise protocol will be shown to the control group during the retest day of the study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Exercise

Other

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.

No exercise

Other

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

Primary outcomes

  1. sleep quality

    Time frame: change between baseline and eight weeks

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

  2. IL-6 Biomarker

    Time frame: change between baseline and eight weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Everett Lohman, Dsc

CONTACT

[email protected]

(909) 558-1000 ext. 83171

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

The Effects of Short-Term Circuit Strength Training Intervention on Muscle Mass, Metabolic Health, Balance, Quality of Life, and Inflammaging in Sedentary Postmenopausal Women

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 6, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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