Metabolic SyndromeNCT04014686
12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women
A study testing No exercise intervention group and Resistance band exercise intervention group in people with Metabolic Syndrome and Dyslipidemias, run by Pusan National University at 1 site in United States.
Trial summary
The purpose of this study was to examine the impacts of a 12-week resistance band exercise program on insulin resistance, blood lipid profiles, body composition, and blood pressure in postmenopausal women with obesity. Thirty-six postmenopausal women participated in this study. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Metabolic Syndrome, Dyslipidemias, Insulin Resistance
- What is being tested?
- No exercise intervention group and Resistance band exercise intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 1 Oct 2018
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- postmenopausal (cessation of menses for at least 12 consecutive months)
- abdominal obesity (waist > 80 cm)
Who cannot join
- current smoker (smoking within 6 months of participation)
- cardiovascular disease
- renal disease
- pulmonary disease
- thyroid disease
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Nebraska at Omaha
Omaha, Nebraska, 68182
About this study
Official title: Impacts of 12 Weeks of Resistance Band Exercise Training on Insulin Resistance, Blood Lipids, Body Composition, and Blood Pressure in Postmenopausal Women With Obesity
The purpose of this study was to examine the impacts of a 12-week resistance band exercise program on insulin resistance, blood lipid profiles, body composition, and blood pressure in postmenopausal women with obesity.
Thirty-six postmenopausal women participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 18) or the control group (CON, n = 18). The EX group performed a resistance band exercise training program 60 minutes per day, 3 times per week, for 12 weeks. The CON group did not participate in any exercise, dietary, or behavioral intervention. Blood glucose, insulin, homeostatic model of insulin resistance (HOMA-IR), blood lipids, blood pressure, and body composition were measured before and after 12 weeks of EX or CON.
- Conditions
- Metabolic Syndrome, Dyslipidemias, Insulin Resistance, Hypertension
- Being tested
- No exercise intervention group, Resistance band exercise intervention group
- Keywords
- postmenopausal, exercise
- Medical subject headings
- Metabolic Syndrome, Dyslipidemias, Insulin Resistance, Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No exercise intervention groupOther
no exercise intervention
Resistance band exercise intervention groupBehavioural
Resistance band exercise training intervention (12 weeks, 3x per week, for 60 minutes per day)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | No exercise intervention Receives: Other: No exercise intervention group |
| Exercise intervention group | Experimental | Exercise intervention group (resistance band exercise training for 12 weeks, 3x per week, for 60 minutes per day). Receives: Behavioral: Resistance band exercise intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
Blood glucose was measured before and after 12 weeks.
Measured: 12 weeks
Insulin
Blood insulin was measured before and after 12 weeks.
Measured: 12 weeks
Percentage of Body Fat
Body fat percentage was measured before and after 12 weeks.
Measured: 12 weeks
Waist circumference
Waist circumference was measured before and after 12 weeks.
Measured: 12 weeks
Secondary outcomes (2)
Systolic blood pressure
Systolic blood pressure was measured before and after 12 weeks.
Measured: 12 weeks
Diastolic blood pressure
Diastolic blood pressure was measured before and after 12 weeks.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Apr 2018
- Primary completion1 Aug 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- exercise intervention group, control group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-Eui University, University of Nebraska
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04014686
- Sponsor's protocol ID
- UNOmaha9
- Status last verified
- Oct 2020
- First submitted
- 8 Jul 2019
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of 12 Weeks of Resistance Band Exercise Training on Insulin Resistance, Blood Lipids, Body Composition, and Blood Pressure in Postmenopausal Women With Obesity
- ClinicalTrials.gov ID
- NCT04014686
- Acronym / sponsor ID
- UNOmaha9
- Conditions
- Metabolic Syndrome, Dyslipidemias, Insulin Resistance, Hypertension
- Keywords
- postmenopausal, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Dong-Eui University, University of Nebraska
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 10 Jul 2019 (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 study was to examine the impacts of a 12-week resistance band exercise program on insulin resistance, blood lipid profiles, body composition, and blood pressure in postmenopausal women with obesity.
Thirty-six postmenopausal women participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 18) or the control group (CON, n = 18). The EX group performed a resistance band exercise training program 60 minutes per day, 3 times per week, for 12 weeks. The CON group did not participate in any exercise, dietary, or behavioral intervention. Blood glucose, insulin, homeostatic model of insulin resistance (HOMA-IR), blood lipids, blood pressure, and body composition were measured before and after 12 weeks of EX or CON.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- exercise intervention group, control group
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: No exercise intervention groupNo exercise intervention |
| Exercise intervention group | Experimental | Behavioral: Resistance band exercise intervention groupExercise intervention group (resistance band exercise training for 12 weeks, 3x per week, for 60 minutes per day). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- postmenopausal (cessation of menses for at least 12 consecutive months)
- abdominal obesity (waist > 80 cm)
Key exclusion criteria (5 listed)
- current smoker (smoking within 6 months of participation)
- cardiovascular disease
- renal disease
- pulmonary disease
- thyroid disease
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 |
|---|---|---|
| No exercise intervention groupno exercise intervention | Other | Control group |
| Resistance band exercise intervention groupResistance band exercise training intervention (12 weeks, 3x per week, for 60 minutes per day) | Behavioural | Exercise intervention group |
Primary outcome
Glucose
Time frame: 12 weeks
Blood glucose was measured before and after 12 weeks.
Insulin
Time frame: 12 weeks
Blood insulin was measured before and after 12 weeks.
Percentage of Body Fat
Time frame: 12 weeks
Body fat percentage was measured before and after 12 weeks.
Waist circumference
Time frame: 12 weeks
Waist circumference was measured before and after 12 weeks.
2 secondary outcomes
Systolic blood pressure
Time frame: 12 weeks
Diastolic blood pressure
Time frame: 12 weeks
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 3 Nov 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No exercise intervention group and Resistance band exercise intervention group in people with Metabolic Syndrome and Dyslipidemias, run by Pusan National 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 2 inclusion and 5 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 3 Nov 2020. 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. Some participants in this study may receive a placebo. 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?
Glucose (time frame: 12 weeks). The study lists 4 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 3 Nov 2020.