Actively Recruiting

Age: 18Years +
All Genders
ID06317831

LetS Get fUnctional! Functional Status in People With Interstitial Lung Disease - the SUNSET Study

Led by Aveiro University · Updated on 2024-04-30

150

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

A

Aveiro University

Lead Sponsor

F

Fundação para a Ciência e a Tecnologia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying people with interstitial lung diseases (ILD) to understand how their ability to perform daily activities, called functional status, changes over time. The study aims to explore what causes declines in functional status, evaluate tools that measure this ability, gather patients' perspectives through interviews, track progression over two years, and develop a combined index to predict mortality. ILD causes lung inflammation and scarring, leading to breathing difficulties and muscle weakness that affect daily functioning and quality of life. This observational study includes several tasks: first, validating functional status measurement tools with assessments at baseline and one week later; second, conducting interviews to capture patient experiences; third, tracking functional status and health outcomes every six months for two years aligned with routine appointments; and finally, using collected data to create a multidimensional index predicting mortality. Assessments involve physical tests, questionnaires, interviews, and clinical data collection. Participants will be involved in about 90-minute sessions for each assessment at designated hospitals. Researchers will collect data on muscle strength, physical activity, symptoms, quality of life, hospitalizations, and mortality. The primary outcome is measured by the Short Physical Performance Battery at multiple time points. Safety and health status are monitored throughout, with data analyzed to understand functional decline and its impact in ILD over time.

CONDITIONS

Brief Title

LetS Get fUnctional! FuNctional Status in pEople With intersTitial Lung Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Diagnosed with any type of interstitial lung disease (ILD)
  • Fluent in Portuguese
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Other respiratory diseases
  • History of acute cardiac or respiratory condition in the previous month
  • Signs of cognitive impairment
  • Significant cardiovascular, neurological, or musculoskeletal disease limiting participation
  • Current cancer (neoplasia)
  • Other autoimmune diseases besides ILD

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for informed consent and eligibility confirmation

Baseline Assessment

Duration - 1 day

Participants complete baseline functional status assessments and interviews to characterize their current health and functional abilities.

1 baseline visit (in-person) coinciding with routine appointment

Early Follow-up Assessment

Duration - 1 day

Participants complete a second functional status assessment 7 days after baseline to validate measures.

1 follow-up visit (in-person) approximately 7 days after baseline

Longitudinal Monitoring

Duration - 24 months

Participants are observed over 24 months with repeated assessments of functional status and health outcomes during routine appointments.

4 visits (in-person) at 6, 12, 18, and 24 months aligned with routine care

Trial Site Locations

Total: 1 location

1

University of Aveiro

Aveiro, Portugal, 3810-193

Actively Recruiting

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Research Team

A

Alda S. Marques, PhD

O

Odete M. Alves, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Patient-centered Outcomes Research in Interstitial Lung Disease: An Official American Thoracic Society Research Statement.

Kerri I Aronson, Sonye K Danoff, Anne-Marie Russell...

https://pubmed.ncbi.nlm.nih.gov/34283696

Epidemiology of interstitial lung diseases and their progressive-fibrosing behaviour in six European countries.

Ole Hilberg, Anna-Maria Hoffmann-Vold, Vanessa Smith...

https://pubmed.ncbi.nlm.nih.gov/35083316

Effectiveness of pulmonary rehabilitation in patients with interstitial lung disease of different etiology: a multicenter prospective study.

Roberto Tonelli, Elisabetta Cocconcelli, Barbara Lanini...

https://pubmed.ncbi.nlm.nih.gov/29017478

Functional status measurement in COPD: a review of available methods and their feasibility in primary care.

Janwillem W H Kocks, Guus M Asijee, Ioanna G Tsiligianni...

https://pubmed.ncbi.nlm.nih.gov/21523316

Interobserver Reliability of Peripheral Muscle Strength Tests and Short Physical Performance Battery in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Observational Study.

Francesc Medina-Mirapeix, Roberto Bernabeu-Mora, Eduardo Llamazares-Herrán...

https://pubmed.ncbi.nlm.nih.gov/27255806