NCT03440489

Brief Summary

Interstitial lung disease includes a heterogeneous group of chronic lung conditions that is characterized by exertional dyspnoea and poor health related quality of life . includes idiopathic pulmonary fibrosis of unknown cause And another groups are caused by occupational, inorganic or organic exposure, drug- induced toxicities, or are secondaries to connective tissue disease The clinical course and outcome of interstitial lung diseases are highly variable between different sub types, but survival after diagnosis of idiopathic pulmonary fibrosis is only 2.5 to 5 years is a progressive and fibrosing lung disease that is characterized by architectural distortion of the lung parenchyma and is progressive, with a dismal prognosis Also patient with idiopathic pulmonary fibrosis generally demonstrate greater abnormalities of exercise induced gas exchange than those with other forms of Interstitial lung disease

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

February 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 22, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

February 9, 2018

Last Update Submit

February 19, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • assess skeletal muscle dysfunction in interstitial lung diseased patients by 30 seconds chair stand test

    30 seconds chair stand test

    30 seconds

Study Arms (1)

six-minute walking test

OTHER

physical performance of the muscle: measured by Gait speed test, Timed up and go test, six-minute walking test , 30 seconds chair stand test

Diagnostic Test: Six-minute walking testDiagnostic Test: 30 seconds chair stand test

Interventions

physical performance of the muscle measured by these tests

Also known as: Gait speed test, Timed up and go test
six-minute walking test

physical performance of the muscle measured by these tests

six-minute walking test

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patient who will be presented to assuit chest department and diagnosed as IPF.

You may not qualify if:

  • IPF patient with malignant tumors. 2-Comorbid end stage renal, cardiac or hepatic patient. 3-patient who refused to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Collard HR, King TE Jr, Bartelson BB, Vourlekis JS, Schwarz MI, Brown KK. Changes in clinical and physiologic variables predict survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2003 Sep 1;168(5):538-42. doi: 10.1164/rccm.200211-1311OC. Epub 2003 May 28.

    PMID: 12773325BACKGROUND
  • Travis WD, Costabel U, Hansell DM, King TE Jr, Lynch DA, Nicholson AG, Ryerson CJ, Ryu JH, Selman M, Wells AU, Behr J, Bouros D, Brown KK, Colby TV, Collard HR, Cordeiro CR, Cottin V, Crestani B, Drent M, Dudden RF, Egan J, Flaherty K, Hogaboam C, Inoue Y, Johkoh T, Kim DS, Kitaichi M, Loyd J, Martinez FJ, Myers J, Protzko S, Raghu G, Richeldi L, Sverzellati N, Swigris J, Valeyre D; ATS/ERS Committee on Idiopathic Interstitial Pneumonias. An official American Thoracic Society/European Respiratory Society statement: Update of the international multidisciplinary classification of the idiopathic interstitial pneumonias. Am J Respir Crit Care Med. 2013 Sep 15;188(6):733-48. doi: 10.1164/rccm.201308-1483ST.

    PMID: 24032382BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Mohamed Abd El-ghany

    Assiut University

    STUDY CHAIR
  • Atef el karn

    Assiut University

    STUDY CHAIR
  • Sahar Farghaly yuessif

    Assiut University

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: skeletal muscle dysfunction in patient with idiopathic pulmonary fibrosis six minute walking test
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 22, 2018

Study Start

July 1, 2018

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

February 22, 2018

Record last verified: 2018-02