NCT04014686

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

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
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

July 8, 2019

Last Update Submit

October 30, 2020

Conditions

Keywords

postmenopausalexercise

Outcome Measures

Primary Outcomes (4)

  • Glucose

    Blood glucose was measured before and after 12 weeks.

    12 weeks

  • Insulin

    Blood insulin was measured before and after 12 weeks.

    12 weeks

  • Percentage of Body Fat

    Body fat percentage was measured before and after 12 weeks.

    12 weeks

  • Waist circumference

    Waist circumference was measured before and after 12 weeks.

    12 weeks

Secondary Outcomes (2)

  • Systolic blood pressure

    12 weeks

  • Diastolic blood pressure

    12 weeks

Study Arms (2)

Control group

SHAM COMPARATOR

No exercise intervention

Other: No exercise intervention group

Exercise intervention group

EXPERIMENTAL

Exercise intervention group (resistance band exercise training for 12 weeks, 3x per week, for 60 minutes per day).

Behavioral: Resistance band exercise intervention group

Interventions

no exercise intervention

Control group

Resistance band exercise training intervention (12 weeks, 3x per week, for 60 minutes per day)

Exercise intervention group

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale, postmenopausal
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • postmenopausal (cessation of menses for at least 12 consecutive months)
  • abdominal obesity (waist \> 80 cm)

You may not qualify if:

  • current smoker (smoking within 6 months of participation)
  • cardiovascular disease
  • renal disease
  • pulmonary disease
  • thyroid disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Metabolic SyndromeDyslipidemiasInsulin ResistanceHypertensionMotor Activity

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLipid Metabolism DisordersVascular DiseasesCardiovascular DiseasesBehavior

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

July 8, 2019

First Posted

July 10, 2019

Study Start

April 1, 2018

Primary Completion

August 1, 2018

Study Completion

October 1, 2018

Last Updated

November 3, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations