Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 60 of 10364 for:    strength

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02321059
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : June 26, 2015
Sponsor:
Information provided by (Responsible Party):
Kristian Kiim Jensen, Bispebjerg Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Incisional Hernia Device: Measurement of abdominal wall strength

Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Validation of the Goodstrength System for Assessment of Abdominal Wall Strength in Patients With Incisional Hernia
Study Start Date : November 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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




Primary Outcome Measures :
  1. Abdominal wall strength measured by the Goodstrength system [ Time Frame: One week ]
    Change in abdominal wall strength from baseline to follow-up.


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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients on waiting list for repair of a ventral incisional hernia and healthy volunteers.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321059


Locations
Layout table for location information
Denmark
Bispebjerg Hospital
Copenhagen NV, Copenhagen, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
Layout table for investigator information
Principal Investigator: Kristian K Jensen, MD Bispebjerg Hospital

Layout table for additonal information
Responsible Party: Kristian Kiim Jensen, MD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT02321059     History of Changes
Other Study ID Numbers: H-1-2014-008
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: June 26, 2015
Last Verified: June 2015
Keywords provided by Kristian Kiim Jensen, Bispebjerg Hospital:
incisional hernia
hernia
abdominal wall strength
validation
physical activity
Additional relevant MeSH terms:
Layout table for MeSH terms
Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes