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Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis

Primary Purpose

Interstitial Lung Disease, Skeletal Muscle Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Six-minute walking test
30 seconds chair stand test
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Interstitial Lung Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    six-minute walking test

    Arm Description

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    February 9, 2018
    Last Updated
    February 19, 2018
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03440489
    Brief Title
    Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis
    Official Title
    Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 2018 (Anticipated)
    Primary Completion Date
    May 2020 (Anticipated)
    Study Completion Date
    July 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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
    Detailed Description
    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 People with exhibit limitation in peak exercise capacity, which is associated with impaired ventilation, gas exchange and pulmonary perfusion abnormalities Also in people with interstitial lung diseases there is a relationship between quadriceps muscle weakness and exercise capacity raising the importance of skeletal muscle dysfunction. Furthermore, since interstitial lung diseases is the leading diagnosis referred for lung transplant characterizing skeletal muscle dysfunction and its relationship to exercise capacity prior to lung transplant is of specific interest for this population. The cause of muscle dysfunction in individuals with lung disease is multifactorial, including factors such as disuse, hypoxaemia, malnutrition, oxidative stress, systemic inflammation and medication Pulmonary inflammation and oxidative stress are thought to be pivotal in the pathogenesis of idiopathic interstitial pneumonia

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Interstitial Lung Disease, Skeletal Muscle Dysfunction

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    skeletal muscle dysfunction in patient with idiopathic pulmonary fibrosis six minute walking test
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    six-minute walking test
    Arm Type
    Other
    Arm Description
    physical performance of the muscle: measured by Gait speed test, Timed up and go test, six-minute walking test , 30 seconds chair stand test
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Six-minute walking test
    Other Intervention Name(s)
    Gait speed test, Timed up and go test
    Intervention Description
    physical performance of the muscle measured by these tests
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    30 seconds chair stand test
    Intervention Description
    physical performance of the muscle measured by these tests
    Primary Outcome Measure Information:
    Title
    assess skeletal muscle dysfunction in interstitial lung diseased patients by 30 seconds chair stand test
    Description
    30 seconds chair stand test
    Time Frame
    30 seconds

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: All patient who will be presented to assuit chest department and diagnosed as IPF. Exclusion Criteria: 1-IPF patient with malignant tumors. 2-Comorbid end stage renal, cardiac or hepatic patient. 3-patient who refused to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    seham abd elmouty
    Phone
    01016887257
    Email
    Sehamabdelmouty90@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Abd El-ghany
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Atef el karn
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Sahar Farghaly yuessif
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    12773325
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24032382
    Citation
    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.
    Results Reference
    background

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    Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis

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