Back to results12 Weeks of Resistance Band Exercise Impacts on Adiposity, Hormones, and Blood Pressure in Postmenopausal Women
Primary Purpose
Hypertension, Hormone Disturbance, Adiposity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance band exercise intervention
No exercise intervention group
Sponsored by
About this trial
This is an interventional health services research trial for Hypertension focused on measuring postmenopausal, exercise
Eligibility Criteria
Inclusion Criteria:
- postmenopausal
- hypertensive
- sedentary (no regular exercise training or physical activity within previous year)
Exclusion Criteria:
- premenopausal
- renal, pulmonary, and/or heart disease
- regularly physically active
Sites / Locations
- Song-Young Park
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Control group
Resistance band exercise intervention
Arm Description
No exercise intervention
Exercise intervention group (resistance band exercise training for 12 weeks, 5x per week, for 60 minutes per day).
Outcomes
Primary Outcome Measures
estradiol
Estradiol levels were measured pre- and post-exercise in picograms per milliliter (pg/mL)
Secondary Outcome Measures
Full Information
NCT ID
NCT03919201
First Posted
April 15, 2019
Last Updated
October 27, 2020
Sponsor
Pusan National University
1. Study Identification
Unique Protocol Identification Number
NCT03919201
Brief Title
12 Weeks of Resistance Band Exercise Impacts on Adiposity, Hormones, and Blood Pressure in Postmenopausal Women
Official Title
Impacts of 12 Weeks of Resistance Band Exercise Training on Body Composition, Aging-related Hormones, and Blood Pressure in Postmenopausal Women With Hypertension
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
July 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University
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 body composition, aging-related hormones, and blood pressure in postmenopausal women with stage 1 hypertension. Twenty postmenopausal women with hypertension participated in this study. Participants were randomly allocated into the resistance band training group (EX, n = 10) or the control group (CON, n = 10). The EX group performed a resistance band exercise training program at jump rope training program at 40-70% of their heart rate reserve (HRR) 5 days/week for 12 weeks (sessions 60 minutes in duration). The CON group did not participate in any exercise, dietary, or behavioral intervention. Body composition, aging-related hormones (growth hormone, insulin-like growth factor 1, dehydroepiandrosterone, and estradiol), and blood pressure were measured before and after the 12-weeks study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hormone Disturbance, Adiposity
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
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
No exercise intervention
Arm Title
Resistance band exercise intervention
Arm Type
Experimental
Arm Description
Exercise intervention group (resistance band exercise training for 12 weeks, 5x per week, for 60 minutes per day).
Intervention Type
Other
Intervention Name(s)
Resistance band exercise intervention
Intervention Description
Resistance band exercise intervention (12 weeks, 5x per week, 60 minutes per day)
Intervention Type
Other
Intervention Name(s)
No exercise intervention group
Intervention Description
Control group: no exercise intervention
Primary Outcome Measure Information:
Title
estradiol
Description
Estradiol levels were measured pre- and post-exercise in picograms per milliliter (pg/mL)
Time Frame
12 weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Postmenopausal women (cessation of menses for a minimum of 12 consecutive months)
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
postmenopausal
hypertensive
sedentary (no regular exercise training or physical activity within previous year)
Exclusion Criteria:
premenopausal
renal, pulmonary, and/or heart disease
regularly physically active
Facility Information:
Facility Name
Song-Young Park
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68182
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31663986
Citation
Son WM, Pekas EJ, Park SY. Twelve weeks of resistance band exercise training improves age-associated hormonal decline, blood pressure, and body composition in postmenopausal women with stage 1 hypertension: a randomized clinical trial. Menopause. 2020 Feb;27(2):199-207. doi: 10.1097/GME.0000000000001444. Erratum In: Menopause. 2021 Feb 1;28(2):230.
Results Reference
derived
Learn more about this trial
12 Weeks of Resistance Band Exercise Impacts on Adiposity, Hormones, and Blood Pressure in Postmenopausal Women
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