Londrina Activities of Daily Living Protocol in Pulmonary Hypertension

Not yet recruiting

• Conditions: Pulmonary Hypertension

• Registration Number: NCT07206173
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

The aim of this observational study is to evaluate the validity and reliability of the Londrina Daily Living Activities Protocol in patients diagnosed with pulmonary hypertension (PH).

Detailed Description

Pulmonary hypertension (PH) is a progressive cardiopulmonary disorder characterized by elevated pulmonary artery pressure, which can lead to right ventricular dysfunction and ultimately heart failure. Right heart catheterization is used to diagnose the disease, and individuals are diagnosed with PH when the mean pulmonary artery pressure is 20 mmHg or higher. The most common and most prominent symptom at diagnosis that prompts referral of PH patients for medical intervention is dyspnea. Dyspnea affects even mild cases of PH, and exertional dyspnea is present in most patients. This significantly impacts patients' functional capacity, quality of life, and overall survival. Even in mild PH, numerous pathological changes contribute significantly to exercise limitation. The multifactorial pathophysiology of exercise limitation in PH involves the circulatory, respiratory, and peripheral muscle systems.

Given the multifaceted nature of pulmonary hypertension and its profound effects on daily functioning, a comprehensive assessment tool is needed to accurately evaluate daily living activities in this patient population. Accurate and reliable assessment of activities of daily living (ADL) is of great importance in the management of pulmonary hypertension, considering the impact of the disease on function. Decreased exercise tolerance in PH, along with reduced quality of life, including physical function and mental health, and decreased physical activity levels, affects every aspect of daily life, placing a significant "disease burden" on the patient.

Quality of life can be assessed primarily using two methods: performance-based tests, which observe the individual's performance while performing standardized activities, and questionnaires, which measure limitations based on the individual's own statements. Performance-based tests offer the advantage of observing the individual's actual performance and identifying potential limitations that may occur during these activities.

The Londrina Activities of Daily Living Protocol is an assessment protocol that aims to evaluate daily living activities and has undergone validity and reliability studies in diseases such as chronic obstructive pulmonary disease, systemic sclerosis, and asthma.

The aim of this study is to evaluate the validity and reliability of the Londrina Activities of Daily Living Protocol in PH.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-17
• Study First Submitted QC: 2025-09-25
• Last Update Submitted: 2025-09-25
• Study Start: 2025-09-29
• Study First Posted: 2025-10-03
• Last Update Posted: 2025-10-03
• Primary Completion: 2025-12-15
• Study Completion: 2025-12-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Being diagnosed with pulmonary hypertension (PH)
• Being 18 years of age or older
• Agreeing to participate in the study

Exclusion Criteria

• Acute decompensated heart failure
• Orthopedic or neurological disorders that prevent the test from being performed
• Patients who have difficulty understanding the instructions given

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Londrina Activities of Daily Living Protocol	15 minutes	The Londrina ADL protocol will be performed. This protocol consists of a total of 5 stations containing different tasks (arranging objects, walking with weights, organizing objects, organizing clothes and walking). Participants will be asked to perform the tasks at these stations at the speed they would perform them in real life. The duration of the protocol will be recorded in seconds.; The protocol will be repeated using the same method as the initial evaluation after the patient has rested for at least 30 minutes.
Metabolic Cost of Londirna Activities of Daily Living Protocol	15 minutes	The Londrina ADL protocol will be performed with a mobile ergospirometer (K5, Cosmed). Cardipulmonary test variables (oxygen consumption,ventilation, dyspnea, fatigue) obtained during the protocol will be recorded.; The protocol will be repeated using the same method as the initial evaluation after the patient has rested for at least 30 minutes.

Secondary Outcome Measures

Name	Time	Method
London Chest Activities of Daily Living Scale	5 minutes	It is a questionnaire consisting of fifteen items. Each item is given a score ranging from 0 to 5. Higher scores indicate greater limitation in activities of daily living. The total score can reach a maximum of 75
Functional capacity	6 minutes	The 6-minute walk test will be performed.

Trial Locations

Locations (1)

Istanbul University - Cerrahpasa; Istanbul, Turkey (Türkiye)