Interstitial Lung DiseaseNCT03440489
Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis
A study testing Six-minute walking test and 30 seconds chair stand test in people with Interstitial Lung Disease and Skeletal Muscle Dysfunction, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interstitial Lung Disease, Skeletal Muscle Dysfunction
- What is being tested?
- Six-minute walking test and 30 seconds chair stand test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patient who will be presented to assuit chest department and diagnosed as IPF.
Who cannot join
- 1-IPF patient with malignant tumors. 2-Comorbid end stage renal, cardiac or hepatic patient. 3-patient who refused to participate in the study
Trial locations and contacts
No sites are listed yet.
About this study
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
Read the 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
- Being tested
- Six-minute walking test, 30 seconds chair stand test
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Six-minute walking testDiagnostic test
Also called Gait speed test, Timed up and go test
physical performance of the muscle measured by these tests
30 seconds chair stand testDiagnostic test
physical performance of the muscle measured by these tests
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Six-minute walking test; Diagnostic Test: 30 seconds chair stand test |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess skeletal muscle dysfunction in interstitial lung diseased patients by 30 seconds chair stand test
30 seconds chair stand test
Measured: 30 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startJul 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- skeletal muscle dysfunction in patient with idiopathic pulmonary fibrosis six minute walking test
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seham abd elmouty, Assiut University
- Investigators
- Mohamed Abd El-ghany, Study chair, Assiut UniversityAtef el karn, Study chair, Assiut UniversitySahar Farghaly yuessif, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440489
- Sponsor's protocol ID
- SMD
- Status last verified
- Feb 2018
- First submitted
- 9 Feb 2018
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 12773325Travis 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.
PubMed 24032382
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skeletal Muscle Dysfunction in Patient With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT03440489
- Acronym / sponsor ID
- SMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- skeletal muscle dysfunction in patient with idiopathic pulmonary fibrosis six minute walking test
| Arm | Type | Receives |
|---|---|---|
| six-minute walking test | Other | Diagnostic Test: Six-minute walking test, Diagnostic Test: 30 seconds chair stand testphysical performance of the muscle: measured by Gait speed test, Timed up and go test, six-minute walking test , 30 seconds chair stand test |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patient who will be presented to assuit chest department and diagnosed as IPF.
Key exclusion criteria (1 listed)
- 1-IPF patient with malignant tumors. 2-Comorbid end stage renal, cardiac or hepatic patient. 3-patient who refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Six-minute walking testAlso: Gait speed test, Timed up and go testphysical performance of the muscle measured by these tests | Diagnostic test | six-minute walking test |
| 30 seconds chair stand testphysical performance of the muscle measured by these tests | Diagnostic test | six-minute walking test |
Primary outcome
assess skeletal muscle dysfunction in interstitial lung diseased patients by 30 seconds chair stand test
Time frame: 30 seconds
30 seconds chair stand test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
- Background: PubMed 12773325Collard 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.
- Background: PubMed 24032382Travis 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Abd El-ghany study chair
Assiut University
Atef el karn study chair
Assiut University
Sahar Farghaly yuessif study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Six-minute walking test and 30 seconds chair stand test in people with Interstitial Lung Disease and Skeletal Muscle Dysfunction, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact seham abd elmouty (01016887257, Sehamabdelmouty90@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess skeletal muscle dysfunction in interstitial lung diseased patients by 30 seconds chair stand test (time frame: 30 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03440489, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.