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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAveiro University

About this trial

This study aims to i) To characterize the functional status and explore the determinants of functional status decline of people with IlD ii)To determine the measurement properties of functional status instruments in people with Interstitial lung diseases (ILD) iii) To identify the impact of ILD and the participants' perspectives on functional status through interviews iv) Explore the progression of functional status progression in people with ILD and v) Develop a multidimensional index, incorporating functional status parameters, to predict mortality in people with ILD.

Patients with ILD will be recruited via the pulmonology services at hospitals, namely from Centro Hospitalar de Vila Nova de Gaia/Espinho (CHVNG/E), Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre o Douro e Vouga (CHEDV). Sociodemographic, clinical characteristics (i.e., smoking habits, vital signs and symptoms), anthropometric (i.e., height and weight to compute body mass index) and general clinical data (i.e., medication, oxygen therapy, non-invasive ventilation, acute exacerbations, hospitalizations and number of hospital admissions in the last month and year, length of stay), as well as prior and follow-up spirometric measurements and arterial blood gas will be collected from clinical records for patients' characterization. Mortality and rehospitalizations will be explored during the study period. Peripheral muscle strength, functional status, daily physical activity, self-reported symptoms, functional status, impact of the disease and health-related quality of life. Qualitative data from interviews.

The assessments will be conducted at 6 time points: baseline and 1 week after for instrument validation, followed by assessments every 6 months for 2 years.

It is expected that: i) Functional status limitations can be comprehensively identified and measured in individuals with ILD. ii) Some measures are valid and reliable indicators of functional status in individuals with ILD. iii) Different profiles of functional status progression will be identified in individuals with ILD, including stable, slow, and fast decline. iv) A multidimensional index incorporating functional status will improve the accuracy of predicting mortality and outperform the predictive ability of the current GAP Index.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years

Diagnosed with any type of ILD

Fluent in Portuguese

Able to provide informed consent.

Disqualifiers

Other respiratory diseases

A history of acute cardiac/respiratory condition in the previous month

Present signs of cognitive impairment

Significant cardiovascular, neurological and/or musculoskeletal disease that may limit their participation

Trial population

People with Interstitial Lung Disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Short physical performance battery (SPPB)

Patients' functional level will be assessed with the short physical performance battery, a simple and easy to perform tool that includes the four-meter gait speed test, the five-repetition sit-to-stand test and a balance test, and gives a total score based on the performance in each of those tests.

Time frame
Two measurements will be assessed at baseline and one at each follow-up (baseline, 6 months, 12 months, 18 months and 24 months)

Secondary outcomes

1

Six Minute Walk Test (6MWT)

The Six Minute Walk Test is the gold standard exercise test and has been validated in people with ILD and is commonly used to assess functional status. The 6MWD is valid and reliable measure in people with ILD, with excellent intra-class correlation coefficients (ICCs= 0.82-0.99).

Time frame
Only one measurement will be assessed in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months).
2

The 1-minute sit-to-stand

The 1-minute sit-to-stand test will be used to also assess functional status.

Time frame
Two measurements will be assessed at baseline and one at each follow-up (baseline, 6 months, 12 months, 18 months and 24 months)
3

The grocery shelving task

The grocery shelving task is valid, reliable and responsive functional outcome measure that incorporates unsupported arm activity in patients with chronic respiratory disease.

Time frame
Two measurements will be conducted in each timepoint (baseline, 6 months, 12 months, 18 months and 24 months) due to the presence of a learning effect with this test.
4

The Physical Performance Test (PPT)

The Physical Performance Test (PPT) is valid and reliable established measure of physical function status.

Time frame
Two measurements will be assessed at baseline and one at each follow-up (baseline, 6 months, 12 months, 18 months and 24 months)

Other outcomes

1

Weight

The participants' weight will be assessed in kilograms.

Time frame
One measurement will be assessed in each timepoint (6 months, 12 months, 18 months and 24 months)
2

Height

The participants' weight will be assessed in meters.

Time frame
One measurement will be assessed in each timepoint (6 months, 12 months, 18 months and 24 months)
3

Body mass index

Patients' body mass index will be assessed in kg/m\^2 based on patients' height and weight.

Time frame
One measurement will be assessed in each timepoint.
4

Heart rate

Heart rate will be assessed in beats per minute using a oximeter and blood pressure meter.

Time frame
One measurement will be assessed in each timepoint.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aveiro University

Lead sponsor

Fundação para a Ciência e a Tecnologia

Collaborator