Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia (VAGSI)

June 25, 2015 updated by: Kristian Kiim Jensen, Bispebjerg Hospital
Patients with an incisional hernia in the midline and controls with an intact abdominal wall are examined twice with one week apart, in order to establish the test-retest reliability and internal and external validity of the Goodstrength trunk dynamometer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Copenhagen NV, Copenhagen, Denmark, 2400
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients on waiting list for repair of a ventral incisional hernia and healthy volunteers.

Description

Inclusion Criteria:

  • American Society of Anesthesiologists score 1-3
  • Age equal to or above 18
  • Ventral incisional hernia OR intact abdominal wall

Exclusion Criteria:

  • Pregnancy
  • Severe heart disease (New York Heart Association class III-IV)
  • Severe pulmonary disease
  • Severe musculoskeletal disease
  • Systemic treatment with glucocorticoid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No incisional hernia group
Healthy volunteers with an intact abdominal wall.
Device: Measurement of abdominal wall strength
Test-retest examination of the reliability of the Goodstrength trunk dynamometer
Incisional hernia group
Patients with a ventral incisional hernia.
Device: Measurement of abdominal wall strength
Test-retest examination of the reliability of the Goodstrength trunk dynamometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal wall strength measured by the Goodstrength system
Time Frame: One week
Change in abdominal wall strength from baseline to follow-up.
One week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity the last week, assessed by the International Physical Activity Questionnaire
Time Frame: Once, at baseline examination
Once, at baseline examination
Self-assessed abdominal wall strength, as measured on a visual analogue scale
Time Frame: Once, at baseline examination
Once, at baseline examination
Trunk extensor strength measured by the Goodstrength system
Time Frame: One week
Change in trunk extensor strength from baseline to follow-up.
One week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Kristian K Jensen, MD, Bispebjerg Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

December 16, 2014

First Posted (Estimate)

December 22, 2014

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1-2014-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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