Clincosm LogoSign in Get a demo

Relationship of Skeletal Muscle Thickness, Strength, and Diaphragm Function in Adults With CF

Sponsor
Marmara University (Other)
Overall Status
Completed
CT.gov ID
NCT04892485
Collaborator
(none)
31
Enrollment
1
Location
7.9
Actual Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

31 CF patients and 23 healthy sex and age-matched volunteers were enrolled. All subjects underwent pulmonary function tests, 6-minute walking tests. Body Mass Index and Fat Free Mass Index were measured via a body composition analyser. Diaphragm ultrasonography (to measure thickening fraction), quadriceps femoris muscle ultrasonography were performed. A dynamometer was used to measure each subjects handgrip strength.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    31 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Relationship of Skeletal Muscle Thickness, Strength, and Diaphragm Function in Adults With CF
    Actual Study Start Date :
    Sep 1, 2017
    Actual Primary Completion Date :
    Apr 30, 2018
    Actual Study Completion Date :
    Apr 30, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    CF patients
    Controls

    Outcome Measures

    Primary Outcome Measures

    1. Muscle Thickness, Strength and Diaphragm Thickening Fraction of CF Patients [2 months]

      Measured via USG and handheld dynamometer

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • CF diagnosed

    • Age 18 and above

    Exclusion Criteria:

    • Having a pulmonary flare up within the previous month

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Marmara University School of Medicine Istanbul Turkey

    Sponsors and Collaborators

    • Marmara University

    Investigators

    • Study Chair: Berrin Ceyhan, Prof, Marmara University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Berrin Ceyhan, Professor, Marmara University
    ClinicalTrials.gov Identifier:
    NCT04892485
    Other Study ID Numbers:
    • 09.2016.341
    First Posted:
    May 19, 2021
    Last Update Posted:
    May 19, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Keywords provided by Berrin Ceyhan, Professor, Marmara University
    CF, nutritional status, peripheral muscle thickness, peripheral muscle strength, diaphragm thickening fraction
    Additional relevant MeSH terms:
    Cystic Fibrosis

    Study Results

    No Results Posted as of May 19, 2021