HypertensionNCT03919201
12 Weeks of Resistance Band Exercise Impacts on Adiposity, Hormones, and Blood Pressure in Postmenopausal Women
A study testing Resistance band exercise intervention and No exercise intervention group in people with Hypertension and Hormone Disturbance, 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 body composition, aging-related hormones, and blood pressure in postmenopausal women with stage 1 hypertension. Twenty postmenopausal women with hypertension participated in this study. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypertension, Hormone Disturbance, Adiposity
- What is being tested?
- Resistance band exercise intervention and No exercise intervention group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 1 Aug 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
- hypertensive
- sedentary (no regular exercise training or physical activity within previous year)
Who cannot join
- premenopausal
- renal, pulmonary, and/or heart disease
- regularly physically active
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Hypertension, Hormone Disturbance, Adiposity
- Being tested
- Resistance band exercise intervention, No exercise intervention group
- Keywords
- postmenopausal, exercise
- Medical subject headings
- Hypertension, Endocrine System Diseases, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance band exercise interventionOther
Resistance band exercise intervention (12 weeks, 5x per week, 60 minutes per day)
No exercise intervention groupOther
Control group: no exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | No exercise intervention Receives: Other: No exercise intervention group |
| Resistance band exercise intervention | Experimental | Exercise intervention group (resistance band exercise training for 12 weeks, 5x per week, for 60 minutes per day). Receives: Other: Resistance band exercise intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
estradiol
Estradiol levels were measured pre- and post-exercise in picograms per milliliter (pg/mL)
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 posted18 Apr 2019
- Study start1 Apr 2018
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919201
- Sponsor's protocol ID
- PusanNU-4
- Status last verified
- Oct 2020
- First submitted
- 15 Apr 2019
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31663986
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 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 Body Composition, Aging-related Hormones, and Blood Pressure in Postmenopausal Women With Hypertension
- ClinicalTrials.gov ID
- NCT03919201
- Acronym / sponsor ID
- PusanNU-4
- Conditions
- Hypertension, Hormone Disturbance, Adiposity
- Keywords
- postmenopausal, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 18 Apr 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 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.
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 |
| Resistance band exercise intervention | Experimental | Other: Resistance band exercise interventionExercise intervention group (resistance band exercise training for 12 weeks, 5x 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 (3 listed)
- postmenopausal
- hypertensive
- sedentary (no regular exercise training or physical activity within previous year)
Key exclusion criteria (3 listed)
- premenopausal
- renal, pulmonary, and/or heart disease
- regularly physically active
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 |
|---|---|---|
| Resistance band exercise interventionResistance band exercise intervention (12 weeks, 5x per week, 60 minutes per day) | Other | Resistance band exercise intervention |
| No exercise intervention groupControl group: no exercise intervention | Other | Control group |
Primary outcome
estradiol
Time frame: 12 weeks
Estradiol levels were measured pre- and post-exercise in picograms per milliliter (pg/mL)
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 29 Oct 2020.
- Derived from this study: PubMed 31663986Son 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.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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 Resistance band exercise intervention and No exercise intervention group in people with Hypertension and Hormone Disturbance, 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 3 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 29 Oct 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?
estradiol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03919201, which also lists 1 linked publication.
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 29 Oct 2020.