Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

Investigation of the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06049004
• Other study ID #: IKC124
• Status: Not yet recruiting
• Start date: November 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: September 2023
• Source: Izmir Katip Celebi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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 the study is to Examine the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis (IPF) patients.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Being diagnosed with idiopathic pulmonary fibrosis (IPF) disease

2. Being 18 years or older

3. Being independent in daily living activities

4. Being able to read and understand Turkish

Exclusion Criteria:

1. The patient refuses to participate in the study

2. 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.)

3. Presence of infection in the last 3 months

4. Those who show changes in their usual symptoms during the protocol

5. Patients who have difficulty understanding the commands given

6. Those who cannot complete all evaluations

Related Conditions & MeSH terms

• Activity, Motor
• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• Activities of Daily Living Protocol
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Katip Celebi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Londrina Activities of Daily Living Protocol	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.	15 minutes
Secondary	Glittre Activities of Daily Living Test:	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.	5 minutes
Secondary	London Chest Activities of Daily Living (ADL) Scale	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.	10 minutes
Secondary	Hand Grip Strength Measurement	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.	5 minutes
Secondary	mMRC Dyspnea Scale	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.	5 minutes
Secondary	Respiratory Function Test	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	10 minutes