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出境医 / 临床实验 / 12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women
12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women
Study Description
Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Metabolic Syndrome Dyslipidemias Insulin Resistance Hypertension | Other: No exercise intervention group Behavioral: Resistance band exercise intervention group | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 36 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | exercise intervention group, control group |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| 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 |
| Actual Study Start Date : | April 1, 2018 |
| Actual Primary Completion Date : | August 1, 2018 |
| Actual Study Completion Date : | October 1, 2018 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Sham Comparator: Control group
No exercise intervention
|
Other: No exercise intervention group
no exercise intervention
|
|
Experimental: Exercise intervention group
Exercise intervention group (resistance band exercise training for 12 weeks, 3x per week, for 60 minutes per day).
|
Behavioral: Resistance band exercise intervention group
Resistance band exercise training intervention (12 weeks, 3x per week, for 60 minutes per day)
|
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Systolic blood pressure [ Time Frame: 12 weeks ]Systolic blood pressure was measured before and after 12 weeks.
- Diastolic blood pressure [ Time Frame: 12 weeks ]Diastolic blood pressure was measured before and after 12 weeks.
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Female, postmenopausal |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- postmenopausal (cessation of menses for at least 12 consecutive months)
- abdominal obesity (waist > 80 cm)
Exclusion Criteria:
- current smoker (smoking within 6 months of participation)
- cardiovascular disease
- renal disease
- pulmonary disease
- thyroid disease
Contacts and Locations
Locations
| United States, Nebraska | |
| The University of Nebraska at Omaha | |
| Omaha, Nebraska, United States, 68182 | |
Sponsors and Collaborators
Pusan National University
Dong-Eui University
University of Nebraska
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 8, 2019 | ||||||
| First Posted Date ICMJE | July 10, 2019 | ||||||
| Last Update Posted Date | November 3, 2020 | ||||||
| Actual Study Start Date ICMJE | April 1, 2018 | ||||||
| Actual Primary Completion Date | August 1, 2018 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | 12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women | ||||||
| Official Title ICMJE | Impacts of 12 Weeks of Resistance Band Exercise Training on Insulin Resistance, Blood Lipids, Body Composition, and Blood Pressure in Postmenopausal Women With Obesity | ||||||
| Brief 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. 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. |
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| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: exercise intervention group, control group Masking: None (Open Label)Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
36 | ||||||
| Original Actual Enrollment ICMJE | Same as current | ||||||
| Actual Study Completion Date ICMJE | October 1, 2018 | ||||||
| Actual Primary Completion Date | August 1, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | Child, Adult, Older Adult | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04014686 | ||||||
| Other Study ID Numbers ICMJE | UNOmaha9 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Won-mok son, Pusan National University | ||||||
| Study Sponsor ICMJE | Pusan National University | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Pusan National University | ||||||
| Verification Date | October 2020 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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