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Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03440489
Recruitment Status : Not yet recruiting
First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
seham abd elmouty, Assiut University

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

Condition or disease Intervention/treatment Phase
Interstitial Lung Disease Skeletal Muscle Dysfunction Diagnostic Test: Six-minute walking test Diagnostic Test: 30 seconds chair stand test Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Intervention Model: Single Group Assignment
Intervention Model Description: skeletal muscle dysfunction in patient with idiopathic pulmonary fibrosis six minute walking test
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
six-minute walking test
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 test
physical performance of the muscle measured by these tests
Other Names:
  • Gait speed test
  • Timed up and go test

Diagnostic Test: 30 seconds chair stand test
physical performance of the muscle measured by these tests




Primary Outcome Measures :
  1. assess skeletal muscle dysfunction in interstitial lung diseased patients by 30 seconds chair stand test [ Time Frame: 30 seconds ]
    30 seconds chair stand test



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03440489


Contacts
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Contact: seham abd elmouty 01016887257 Sehamabdelmouty90@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Mohamed Abd El-ghany Assiut University
Study Chair: Atef el karn Assiut University
Study Chair: Sahar Farghaly yuessif Assiut University

Publications:
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Responsible Party: seham abd elmouty, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03440489     History of Changes
Other Study ID Numbers: SMD
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Respiratory Tract Diseases