NCT04892485

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2021

Completed
Last Updated

May 19, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

May 14, 2021

Last Update Submit

May 14, 2021

Conditions

Cystic Fibrosis

Keywords

CF, nutritional status, peripheral muscle thickness, peripheral muscle strength, diaphragm thickening fraction

Outcome Measures

Primary Outcomes (1)

  • Muscle Thickness, Strength and Diaphragm Thickening Fraction of CF Patients

    Measured via USG and handheld dynamometer

    2 months

Study Arms (2)

CF patients

Controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult CF patients and healty age sex matched controls

You may qualify if:

  • CF diagnosed
  • Age 18 and above

You may not qualify if:

  • Having a pulmonary flare up within the previous month
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Berrin Ceyhan, Prof

    Marmara University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2021

First Posted

May 19, 2021

Study Start

September 1, 2017

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

May 19, 2021

Record last verified: 2021-05

Locations

TU(1)