- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03302702
Duration of Exercise Program in Interstitial Lung Diseases.
A Comparison Trial of Eight Weeks Versus Twelve Weeks of Exercise Program in Interstitial Lung Diseases.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Completed the 12 week exercise program
- Diagnosed with ILD
Exclusion Criteria:
- Not completed 12 week exercise program
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Exercise program
Treatment group
|
Exercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Six minute walk test
Time Frame: 6 minute
|
It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria
|
6 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary Function Test
Time Frame: 20 minutes
|
It was used for assessment of lung functions
|
20 minutes
|
Hospital Anxiety and Depression Inventory
Time Frame: 20 minutes
|
It was used for assessment of anxiety and depression
|
20 minutes
|
mMRC
Time Frame: 5 minutes
|
It was used for dyspnea that patients felt during their daily activities.
|
5 minutes
|
SGRQ
Time Frame: 30 minutes
|
A disease-specific quality of life scale
|
30 minutes
|
SF-36 Health Survey
Time Frame: 30 minutes
|
A health related quality of life scale
|
30 minutes
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKC4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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