NCT07206173

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2025

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 17, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

September 17, 2025

Last Update Submit

May 6, 2026

Conditions

Keywords

Londrina Activities of Daily Living ProtocolPulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

  • Londrina Activities of Daily Living Protocol

    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.

    15 minutes

  • VO2 (ml/kg/min)

    The Londrina ADL protocol will be performed with a mobile ergospirometer (K5, Cosmed). Oxygen consumption (VO2) 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.

    15 minutes

Secondary Outcomes (2)

  • London Chest Activities of Daily Living Scale

    5 minutes

  • Functional capacity

    6 minutes

Interventions

The Londrina Activites of Daily Living Protocol is a performance-based test protocol that objectively evaluates ADL. The participant was instructed to perform the tasks at the stations at the same speed they would typically do at home. The protocol consists of five stations with different tasks consisting of arranging objects, walking with weights, organizing objects, organizing clothes and walking.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients being diagnosed with pulmonary hypertension (PH)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Physiotherapist, PhD

Study Record Dates

First Submitted

September 17, 2025

First Posted

October 3, 2025

Study Start

September 15, 2025

Primary Completion

April 5, 2026

Study Completion

April 20, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

The sharing of this information is restricted by the ethics committee and informed consent form.

Locations