NCT03919201

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable hypertension

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2019

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

April 15, 2019

Last Update Submit

October 27, 2020

Conditions

Keywords

postmenopausalexercise

Outcome Measures

Primary Outcomes (1)

  • estradiol

    Estradiol levels were measured pre- and post-exercise in picograms per milliliter (pg/mL)

    12 weeks

Study Arms (2)

Control group

SHAM COMPARATOR

No exercise intervention

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).

Other: Resistance band exercise intervention

Interventions

Resistance band exercise intervention (12 weeks, 5x per week, 60 minutes per day)

Resistance band exercise intervention

Control group: no exercise intervention

Control group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostmenopausal women (cessation of menses for a minimum of 12 consecutive months)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal
  • hypertensive
  • sedentary (no regular exercise training or physical activity within previous year)

You may not qualify if:

  • premenopausal
  • renal, pulmonary, and/or heart disease
  • regularly physically active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Song-Young Park

Omaha, Nebraska, 68182, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HypertensionEndocrine System DiseasesObesityMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: exercise intervention group, control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 18, 2019

Study Start

April 1, 2018

Primary Completion

July 1, 2018

Study Completion

August 1, 2018

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations