Interstitial Lung DiseaseNCT03302702
Duration of Exercise Program in Interstitial Lung Diseases.
A study testing Exercise program in people with Interstitial Lung Disease, run by Izmir Katip Celebi University.
Trial summary
We aimed to compare the functional results of the 8th week with the results of the 12th week of the exercise programs applied to the patients with ILD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Interstitial Lung Disease
- What is being tested?
- Exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2016
- 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
- Completed the 12 week exercise program
- Diagnosed with ILD
Who cannot join
- Not completed 12 week exercise program
About this study
Official title: A Comparison Trial of Eight Weeks Versus Twelve Weeks of Exercise Program in Interstitial Lung Diseases.
We aimed to compare the functional results of the 8th week with the results of the 12th week of the exercise programs applied to the patients with ILD.
Read the detailed description
Exercise programs (EP) have been shown to be the effective approach for functional outcomes in interstitial lung diseases (ILD). In many studies, the duration of exercise programs varies between 8-12 weeks. However, the optimal duration of exercise program is still unknown.
We aimed to compare the results of the 8th week with the results of the 12th week of the PR programs applied to the patients with ILD.
A total of 14 patients with ILD referred to our PR unit [11 idiopathic pulmonary fibrosis, 2 sarcoidosis (stage 3 and 4) and 1 nonspecific interstitial pneumonia] were included in the study. Pulmonary function test, arterial blood gas analysis, 6- minute walk test, mMRC dyspnea scale, quality of life questionnaires and hospital anxiety depression scale were performed before, at the 8th and 12th weeks after the exercise program applied to the patients twice a week.
- Conditions
- Interstitial Lung Disease
- Being tested
- Exercise program
- Keywords
- exercise, duration
- Medical subject headings
- Lung Diseases, Interstitial, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Exercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training
| Study group | Role | What they receive |
|---|---|---|
| Exercise program | Other | Treatment group Receives: Other: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test
It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria
Measured: 6 minute
Secondary outcomes (5)
mMRC
It was used for dyspnea that patients felt during their daily activities.
Measured: 5 minutes
Pulmonary Function Test
It was used for assessment of lung functions
Measured: 20 minutes
SGRQ
A disease-specific quality of life scale
Measured: 30 minutes
SF-36 Health Survey
A health related quality of life scale
Measured: 30 minutes
Hospital Anxiety and Depression Inventory
It was used for assessment of anxiety and depression
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2017
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03302702
- Sponsor's protocol ID
- IKC4
- Status last verified
- Oct 2017
- First submitted
- 1 Oct 2017
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Trial of Eight Weeks Versus Twelve Weeks of Exercise Program in Interstitial Lung Diseases.
- ClinicalTrials.gov ID
- NCT03302702
- Acronym / sponsor ID
- IKC4
- Conditions
- Interstitial Lung Disease
- Keywords
- exercise, duration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Oct 2017 (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.
We aimed to compare the functional results of the 8th week with the results of the 12th week of the exercise programs applied to the patients with ILD.
Detailed description
Exercise programs (EP) have been shown to be the effective approach for functional outcomes in interstitial lung diseases (ILD). In many studies, the duration of exercise programs varies between 8-12 weeks. However, the optimal duration of exercise program is still unknown.
We aimed to compare the results of the 8th week with the results of the 12th week of the PR programs applied to the patients with ILD.
A total of 14 patients with ILD referred to our PR unit [11 idiopathic pulmonary fibrosis, 2 sarcoidosis (stage 3 and 4) and 1 nonspecific interstitial pneumonia] were included in the study. Pulmonary function test, arterial blood gas analysis, 6- minute walk test, mMRC dyspnea scale, quality of life questionnaires and hospital anxiety depression scale were performed before, at the 8th and 12th weeks after the exercise program applied to the patients twice a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise program | Other | Other: Exercise programTreatment group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Completed the 12 week exercise program
- Diagnosed with ILD
Key exclusion criteria (1 listed)
- Not completed 12 week exercise program
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 |
|---|---|---|
| Exercise programExercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training | Other | Exercise program |
Primary outcome
Six minute walk test
Time frame: 6 minute
It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria
5 secondary outcomes
mMRC
Time frame: 5 minutes
Pulmonary Function Test
Time frame: 20 minutes
SGRQ
Time frame: 30 minutes
SF-36 Health Survey
Time frame: 30 minutes
Hospital Anxiety and Depression Inventory
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2017.
- Individual participant dataSharing planned: No
Related trials for Interstitial Lung Disease
RecruitingPhase 3
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
Pulmonary Hypertension, Interstitial Lung Disease
RecruitingPhase 2
Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
Langerhan's Cell Histiocytosis, Juvenile Xanthogranuloma
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 3
Fibrotic Disease Activity in Cardiopulmonary Disorders Using 18F-Fibroblast Activation Protein Inhibitor (18F-FAPI-74) PET/CT Imaging
Allogeneic Stem Cell Transplantation, Lung Allograft Transplantation
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program in people with Interstitial Lung Disease, run by Izmir Katip Celebi 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 2 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: finished, as of the sponsor's last update on 5 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk test (time frame: 6 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2017.