Idiopathic Pulmonary FibrosisNCT06049004
Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients
An observational study of Idiopathic Pulmonary Fibrosis and Activity, Motor, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Activity, Motor
- What is being tested?
- Activities of Daily Living Protocol
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2023to 1 Nov 2024
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients being diagnosed with idiopathic pulmonary fibrosis (IPF) disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis, Activity, Motor
- Being tested
- Activities of Daily Living Protocol
- Keywords
- idiopathic pulmonary fibrosis, activity daily living, validity, reliability
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activities of Daily Living ProtocolOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes
Secondary outcomes (5)
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.
Measured: 5 minutes
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.
Measured: 10 minutes
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.
Measured: 5 minutes
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.
Measured: 5 minutes
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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Jun 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilknur Naz, Izmir Katip Celebi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06049004
- Sponsor's protocol ID
- IKC124
- Status last verified
- Jun 2025
- First submitted
- 15 Sep 2023
- Last updated
- 5 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity and Reliability of the Londrina Activities of Daily Living Protocol in Idiopathic Pulmonary Fibrosis Patients
- ClinicalTrials.gov ID
- NCT06049004
- Acronym / sponsor ID
- IKC124
- Conditions
- Idiopathic Pulmonary Fibrosis, Activity, Motor
- Keywords
- idiopathic pulmonary fibrosis, activity daily living, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being diagnosed with idiopathic pulmonary fibrosis (IPF) disease
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Activities of Daily Living ProtocolThe 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. | Other | – |
Primary outcome
Londrina Activities of Daily Living Protocol
Time frame: 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.
5 secondary outcomes
Glittre Activities of Daily Living Test:
Time frame: 5 minutes
London Chest Activities of Daily Living (ADL) Scale
Time frame: 10 minutes
Hand Grip Strength Measurement
Time frame: 5 minutes
mMRC Dyspnea Scale
Time frame: 5 minutes
Respiratory Function Test
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis and Activity, Motor, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Londrina Activities of Daily Living Protocol (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.