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Duration of Exercise Program in Interstitial Lung Diseases.

Primary Purpose

Interstitial Lung Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise program
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Lung Disease focused on measuring exercise, duration

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Completed the 12 week exercise program
  • Diagnosed with ILD

Exclusion Criteria:

  • Not completed 12 week exercise program

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Exercise program

    Arm Description

    Treatment group

    Outcomes

    Primary Outcome Measures

    Six minute walk test
    It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria

    Secondary Outcome Measures

    mMRC
    It was used for dyspnea that patients felt during their daily activities.
    Pulmonary Function Test
    It was used for assessment of lung functions
    SGRQ
    A disease-specific quality of life scale
    SF-36 Health Survey
    A health related quality of life scale
    Hospital Anxiety and Depression Inventory
    It was used for assessment of anxiety and depression

    Full Information

    First Posted
    October 1, 2017
    Last Updated
    October 1, 2017
    Sponsor
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03302702
    Brief Title
    Duration of Exercise Program in Interstitial Lung Diseases.
    Official Title
    A Comparison Trial of Eight Weeks Versus Twelve Weeks of Exercise Program in Interstitial Lung Diseases.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2014 (Actual)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Interstitial Lung Disease
    Keywords
    exercise, duration

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise program
    Arm Type
    Other
    Arm Description
    Treatment group
    Intervention Type
    Other
    Intervention Name(s)
    Exercise program
    Intervention Description
    Exercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training
    Primary Outcome Measure Information:
    Title
    Six minute walk test
    Description
    It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria
    Time Frame
    6 minute
    Secondary Outcome Measure Information:
    Title
    mMRC
    Description
    It was used for dyspnea that patients felt during their daily activities.
    Time Frame
    5 minutes
    Title
    Pulmonary Function Test
    Description
    It was used for assessment of lung functions
    Time Frame
    20 minutes
    Title
    SGRQ
    Description
    A disease-specific quality of life scale
    Time Frame
    30 minutes
    Title
    SF-36 Health Survey
    Description
    A health related quality of life scale
    Time Frame
    30 minutes
    Title
    Hospital Anxiety and Depression Inventory
    Description
    It was used for assessment of anxiety and depression
    Time Frame
    20 minutes

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Completed the 12 week exercise program Diagnosed with ILD Exclusion Criteria: Not completed 12 week exercise program

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Duration of Exercise Program in Interstitial Lung Diseases.

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