- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049004
Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients
Investigation of the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Idiopathic pulmonary fibrosis (IPF) is an interstitial lung disease characterized by a restrictive type of breathing disorder. In IPF patients, serious limitations occur in the activities of daily living (ADL) of the patients due to dyspnea and fatigue symptoms, therefore it is very important to evaluate the activities of daily living in this patient group. It is recommended to use protocols created from activities frequently used in daily life to evaluate ADL in chronic respiratory patients. Londrina Activities of Daily Living Protocol is a performance-based objective measurement method based on repetition of daily activities. Participants are asked to perform the activities defined in the protocol at the same speed they do at home, and the completion time of the protocol is recorded. The individual is asked to complete all stations in order from a designated starting line.
The Londrina Activities of Daily Living Protocol was first developed for Chronic Obstructive Pulmonary Disease patients and was found to be valid and reliable, but there is no validity and reliability study of the Londrina Activities of Daily Living Protocol in IPF patients. The purpose of our study is to Examine the Validity and Reliability of the Londrina Activities of Daily Living Protocol in IPF patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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İzmir, Turkey
- Izmir Katip Celebi University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being diagnosed with idiopathic pulmonary fibrosis (IPF) disease
- Being 18 years or older
- Being independent in daily living activities
- Being able to read and understand Turkish
Exclusion Criteria:
- The patient refuses to participate in the study
- People with comorbidities that would make it impossible to perform any of the study evaluations (orthopedic pathology, uncontrolled cardiovascular or neurological conditions, psychiatric illness, etc.)
- Presence of infection in the last 3 months
- Those who show changes in their usual symptoms during the protocol
- Patients who have difficulty understanding the commands given
- Those who cannot complete all evaluations
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Londrina Activities of Daily Living Protocol
Time Frame: 15 minutes
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The protocol is a performance-based objective measurement method based on repetition of daily activities.
Participants are asked to perform the activities defined in the protocol at the same speed they do at home.
The Londrina Protocol includes 5 stations: Station 1 Arranging Objects on the Table, Station 2 Walking with Bags, Station 3 Organizing Shelves, Station 4 Clothesline Task, Station 5 Walking.
The completion time of the protocol is recorded.
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15 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Glittre Activities of Daily Living Test:
Time Frame: 5 minutes
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The test is a submaximal exercise test developed by selecting activities similar to activities of daily living to evaluate functional capacity in COPD.
The test provides information about performance in activities of daily living and may reflect functional capacity.
It is a test that takes place within a distance of 10 m in total.
During the test, female patients carry a 2.5 kg backpack and male patients carry a 5 kg backpack.
The test involves five rounds and patients are asked to complete these rounds as quickly as possible.
Test completion time is recorded.
Glittre ADL Test is a valid and reliable test in patients with idiopathic pulmonary fibrosis.
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5 minutes
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London Chest Activities of Daily Living (ADL) Scale
Time Frame: 10 minutes
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Used in diseases such as COPD and heart failure, to evaluate dyspnea that occurs only with activities of daily living, Garrod et al.
It is a simple, standardized, valid and reliable questionnaire developed by .
This survey consists of 4 parts.
It consists of 15 items in total: self-care: 4 items, housework 6 items, physical activity 2 items, and leisure activities 3 items.
Each item is given a score ranging from 0 to 5. The total score varies between 0-75.
Higher scores indicate greater ADL limitations.
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10 minutes
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Hand Grip Strength Measurement
Time Frame: 5 minutes
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A hand dynamometer will be used to evaluate grip strength (Lafayette Professional Hand Dynamometer 5030L1, USA).
Participants were placed in the standard test position determined by the American Association of Hand Therapists for grip strength measurement.
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5 minutes
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Respiratory Function Test
Time Frame: 10 minutes
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Measurements will be made with a portable spirometer device.
Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), percentages of the FEV1/FVC ratio according to expected values according to age, height, body weight and gender, and inspiratory and expiratory respiratory muscle forces will be recorded
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10 minutes
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mMRC Dyspnea Scale
Time Frame: 5 minutes
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This scale is a five-item scale (0: no dyspnea, 4 severe dyspnea) based on various physical activities that cause the feeling of dyspnea.
Here, patients are asked to mark the level of activity that causes dyspnea.
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5 minutes
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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 (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IKC124
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
product manufactured in and exported from the U.S.
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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