Duration of Exercise Program in Interstitial Lung Diseases. | NCT03302702

Studies
Duration of Exercise Program in Interstitial Lung Diseases.

NCT03302702

Sponsor

Izmir Katip Celebi University

Status

Completed

Last Update Posted

Oct 5, 2017Actual

Enrollment

14Actual

Phase

Not Applicable

Conditions

Interstitial Lung Disease

Interventions

Exercise program

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014Actual

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Oct 1, 2017

First Submission Date that Met QC Criteria

Oct 1, 2017

First Posted Date

Oct 5, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2017

Last Update Posted Date

Oct 5, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise program	Other	Treatment group	Other: Exercise program

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise program	Other	Exercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training	Exercise program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Six minute walk test	It was performed in a 30-meter long corridor in accordance with American Thoracic Society criteria	6 minute

Secondary Outcomes

Measure	Description	Time Frame
mMRC	It was used for dyspnea that patients felt during their daily activities.	5 minutes
Pulmonary Function Test	It was used for assessment of lung functions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completed the 12 week exercise program
Diagnosed with ILD

Exclusion Criteria:

Not completed 12 week exercise program

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017563	Lung Diseases, Interstitial
D009043	Motor Activity

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided