Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients

Sponsor
Izmir Katip Celebi University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06049004
Collaborator
(none)
30
12

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Activities of Daily Living Protocol

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
30 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Investigation of the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Londrina Activities of Daily Living Protocol [15 minutes]

    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.

Secondary Outcome Measures

  1. Glittre Activities of Daily Living Test: [5 minutes]

    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.

  2. London Chest Activities of Daily Living (ADL) Scale [10 minutes]

    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.

  3. Hand Grip Strength Measurement [5 minutes]

    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.

  4. mMRC Dyspnea Scale [5 minutes]

    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. Respiratory Function Test [10 minutes]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Izmir Katip Celebi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ilknur Naz, Assoc. Prof., Izmir Katip Celebi University
ClinicalTrials.gov Identifier:
NCT06049004
Other Study ID Numbers:
  • IKC124
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 25, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ilknur Naz, Assoc. Prof., Izmir Katip Celebi University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2023