Back to results12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women
Primary Purpose
Metabolic Syndrome, Dyslipidemias, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No exercise intervention group
Resistance band exercise intervention group
Sponsored by
About this trial
This is an interventional health services research trial for Metabolic Syndrome focused on measuring postmenopausal, exercise
Eligibility 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
Sites / Locations
- The University of Nebraska at Omaha
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control group
Exercise intervention group
Arm Description
No exercise intervention
Exercise intervention group (resistance band exercise training for 12 weeks, 3x per week, for 60 minutes per day).
Outcomes
Primary Outcome Measures
Glucose
Blood glucose was measured before and after 12 weeks.
Insulin
Blood insulin was measured before and after 12 weeks.
Percentage of Body Fat
Body fat percentage was measured before and after 12 weeks.
Waist circumference
Waist circumference was measured before and after 12 weeks.
Secondary Outcome Measures
Systolic blood pressure
Systolic blood pressure was measured before and after 12 weeks.
Diastolic blood pressure
Diastolic blood pressure was measured before and after 12 weeks.
Full Information
NCT ID
NCT04014686
First Posted
July 8, 2019
Last Updated
October 30, 2020
Sponsor
Pusan National University
Collaborators
Dong-Eui University, University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT04014686
Brief Title
12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University
Collaborators
Dong-Eui University, University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Dyslipidemias, Insulin Resistance, Hypertension
Keywords
postmenopausal, exercise
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
exercise intervention group, control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No exercise intervention
Arm Title
Exercise intervention group
Arm Type
Experimental
Arm Description
Exercise intervention group (resistance band exercise training for 12 weeks, 3x per week, for 60 minutes per day).
Intervention Type
Other
Intervention Name(s)
No exercise intervention group
Intervention Description
no exercise intervention
Intervention Type
Behavioral
Intervention Name(s)
Resistance band exercise intervention group
Intervention Description
Resistance band exercise training intervention (12 weeks, 3x per week, for 60 minutes per day)
Primary Outcome Measure Information:
Title
Glucose
Description
Blood glucose was measured before and after 12 weeks.
Time Frame
12 weeks
Title
Insulin
Description
Blood insulin was measured before and after 12 weeks.
Time Frame
12 weeks
Title
Percentage of Body Fat
Description
Body fat percentage was measured before and after 12 weeks.
Time Frame
12 weeks
Title
Waist circumference
Description
Waist circumference was measured before and after 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Systolic blood pressure
Description
Systolic blood pressure was measured before and after 12 weeks.
Time Frame
12 weeks
Title
Diastolic blood pressure
Description
Diastolic blood pressure was measured before and after 12 weeks.
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female, postmenopausal
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The University of Nebraska at Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68182
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
12 Weeks of Resistance Band Exercise Impacts on Metabolic Syndrome Progression in Postmenopausal Women
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