PostmenopausalNCT06445842
Short-term Circuit Training on Muscle Mass and Quality of Life in Sedentary Postmenopausal Women
A study testing Exercise and No exercise in people with Postmenopausal, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal
- What is being tested?
- Exercise and No exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2024to 25 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Postmenopausal
- Being tested
- Exercise, No exercise
- Keywords
- postmenopausal, balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 exerciseOther
This group will need to maintain their sedentary lifestyle without changing their activity levels or diet
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Experimental | This group will perform exercises three times a week for eight weeks, with each session lasting approximately 45 minutes. Receives: 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 Receives: Other: No exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
sleep quality
The Pittsburgh Sleep Quality Index will be used to measure any trouble sleeping.
Measured: change between baseline and eight weeks
IL-6 Biomarker
Inflammatory biomarker IL-6 will be tested using a blood draw.
Measured: change between baseline and eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start25 May 2024
- Primary completion25 Nov 2025
- Study completion25 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostmenopausalStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Everett Lohman, DSc, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445842
- Sponsor's protocol ID
- 5230490
- Status last verified
- Jul 2026
- First submitted
- 31 May 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06445842
- Acronym / sponsor ID
- 5230490
- Conditions
- Postmenopausal
- Keywords
- postmenopausal, balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- 25 Nov 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: ExerciseThis group will perform exercises three times a week for eight weeks, with each session lasting approximately 45 minutes. |
| Non-Exercise Group | Active comparator | Other: No exerciseThis group will maintain their sedentary lifestyle and will not make any changes to their diet or activity levels during this period |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseThe 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. | Other | Exercise Group |
| No exerciseThis group will need to maintain their sedentary lifestyle without changing their activity levels or diet | Other | Non-Exercise Group |
Primary outcome
sleep quality
Time frame: change between baseline and eight weeks
The Pittsburgh Sleep Quality Index will be used to measure any trouble sleeping.
IL-6 Biomarker
Time frame: change between baseline and eight weeks
Inflammatory biomarker IL-6 will be tested using a blood draw.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Everett Lohman, DSc principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and No exercise in people with Postmenopausal, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep quality (time frame: change between baseline and eight weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.