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
About this trial
This is an interventional screening trial for Interstitial Lung Disease
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
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
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
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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
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Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis
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