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

NCT06317831 | Recruiting

• 1 other identifier: 2023.03936.BDANA
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Interstitial Lung Diseases

Keywords

Functional Status; Interstitial lung diseases; Assessment; Patient-centered care

Outcome Measures

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.

  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 (23)

• Six Minute Walk Test (6MWT)

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

• The 1-minute sit-to-stand

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

• The grocery shelving task

  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.

• The Physical Performance Test (PPT)

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

• Handgrip strenght

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

Other Outcomes (7)

• Weight

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

• Height

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

• Body mass index

  One measurement will be assessed in each timepoint.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

People with Interstitial Lung Disease

You may qualify if:

• ≥18 years
• Diagnosed with any type of ILD
• Fluent in Portuguese
• Able to provide informed consent.

You may not qualify if:

• 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
• Current neoplasia
• Other autoimmune diseases (aside from ID).

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

University of Aveiro

Aveiro, 3810-193, Portugal

RECRUITING

Related Publications (20)

• Aronson KI, Danoff SK, Russell AM, Ryerson CJ, Suzuki A, Wijsenbeek MS, Bajwah S, Bianchi P, Corte TJ, Lee JS, Lindell KO, Maher TM, Martinez FJ, Meek PM, Raghu G, Rouland G, Rudell R, Safford MM, Sheth JS, Swigris JJ. Patient-centered Outcomes Research in Interstitial Lung Disease: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2021 Jul 15;204(2):e3-e23. doi: 10.1164/rccm.202105-1193ST.

  PMID: 34283696 BACKGROUND

• Hilberg O, Hoffmann-Vold AM, Smith V, Bouros D, Kilpelainen M, Guiot J, Morais A, Clemente S, Daniil Z, Papakosta D, Fretheim H, Neves S, Alfaro TM, Antoniou KM, Valveny N, Asijee G, Soulard S, Wuyts W. Epidemiology of interstitial lung diseases and their progressive-fibrosing behaviour in six European countries. ERJ Open Res. 2022 Jan 24;8(1):00597-2021. doi: 10.1183/23120541.00597-2021. eCollection 2022 Jan.

  PMID: 35083316 BACKGROUND

• Dowman L, Hill CJ, May A, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2021 Feb 1;2(2):CD006322. doi: 10.1002/14651858.CD006322.pub4.

  PMID: 34559419 BACKGROUND

• Tonelli R, Cocconcelli E, Lanini B, Romagnoli I, Florini F, Castaniere I, Andrisani D, Cerri S, Luppi F, Fantini R, Marchioni A, Beghe B, Gigliotti F, Clini EM. Effectiveness of pulmonary rehabilitation in patients with interstitial lung disease of different etiology: a multicenter prospective study. BMC Pulm Med. 2017 Oct 10;17(1):130. doi: 10.1186/s12890-017-0476-5.

  PMID: 29017478 BACKGROUND

• Leidy NK. Functional status and the forward progress of merry-go-rounds: toward a coherent analytical framework. Nurs Res. 1994 Jul-Aug;43(4):196-202.

  PMID: 8047422 BACKGROUND

• Kocks JW, Asijee GM, Tsiligianni IG, Kerstjens HA, van der Molen T. Functional status measurement in COPD: a review of available methods and their feasibility in primary care. Prim Care Respir J. 2011 Sep;20(3):269-75. doi: 10.4104/pcrj.2011.00031.

  PMID: 21523316 BACKGROUND

• Dedding C, Cardol M, Eyssen IC, Dekker J, Beelen A. Validity of the Canadian Occupational Performance Measure: a client-centred outcome measurement. Clin Rehabil. 2004 Sep;18(6):660-7. doi: 10.1191/0269215504cr746oa.

  PMID: 15473118 BACKGROUND

• Medina-Mirapeix F, Bernabeu-Mora R, Llamazares-Herran E, Sanchez-Martinez MP, Garcia-Vidal JA, Escolar-Reina P. Interobserver Reliability of Peripheral Muscle Strength Tests and Short Physical Performance Battery in Patients With Chronic Obstructive Pulmonary Disease: A Prospective Observational Study. Arch Phys Med Rehabil. 2016 Nov;97(11):2002-2005. doi: 10.1016/j.apmr.2016.05.004. Epub 2016 May 30.

  PMID: 27255806 BACKGROUND

• Reuben DB, Siu AL. An objective measure of physical function of elderly outpatients. The Physical Performance Test. J Am Geriatr Soc. 1990 Oct;38(10):1105-12. doi: 10.1111/j.1532-5415.1990.tb01373.x.

  PMID: 2229864 BACKGROUND

• Hill CJ, Denehy L, Holland AE, McDonald CF. Measurement of functional activity in chronic obstructive pulmonary disease: the grocery shelving task. J Cardiopulm Rehabil Prev. 2008 Nov-Dec;28(6):402-9. doi: 10.1097/HCR.0b013e31818c3c65.

  PMID: 19008696 BACKGROUND

• Briand J, Behal H, Chenivesse C, Wemeau-Stervinou L, Wallaert B. The 1-minute sit-to-stand test to detect exercise-induced oxygen desaturation in patients with interstitial lung disease. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618793028. doi: 10.1177/1753466618793028.

  PMID: 30091679 BACKGROUND

• Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.

  PMID: 17872937 BACKGROUND

• Dowman L, McDonald CF, Hill CJ, Lee A, Barker K, Boote C, Glaspole I, Goh N, Southcott A, Burge A, Ndongo R, Martin A, Holland AE. Reliability of the hand held dynamometer in measuring muscle strength in people with interstitial lung disease. Physiotherapy. 2016 Sep;102(3):249-55. doi: 10.1016/j.physio.2015.10.002. Epub 2015 Oct 22.

  PMID: 26596172 BACKGROUND

• Karagiannis C, Savva C, Korakakis V, Matheou I, Adamide T, Georgiou A, Xanthos T. Test-Retest Reliability of Handgrip Strength in Patients with Chronic Obstructive Pulmonary Disease. COPD. 2020 Oct;17(5):568-574. doi: 10.1080/15412555.2020.1808604. Epub 2020 Aug 19.

  PMID: 32814452 BACKGROUND

• Reilly CC, Bausewein C, Garrod R, Jolley CJ, Moxham J, Higginson IJ. Breathlessness during daily activity: The psychometric properties of the London Chest Activity of Daily Living Scale in patients with advanced disease and refractory breathlessness. Palliat Med. 2017 Oct;31(9):868-875. doi: 10.1177/0269216316680314. Epub 2016 Dec 15.

  PMID: 27932629 BACKGROUND

• Zhang X, Tan SS, Bilajac L, Alhambra-Borras T, Garces-Ferrer J, Verma A, Koppelaar E, Markaki A, Mattace-Raso F, Franse CB, Raat H. Reliability and Validity of the Tilburg Frailty Indicator in 5 European Countries. J Am Med Dir Assoc. 2020 Jun;21(6):772-779.e6. doi: 10.1016/j.jamda.2020.03.019. Epub 2020 May 6.

  PMID: 32387112 BACKGROUND

• Patel AS, Siegert RJ, Brignall K, Gordon P, Steer S, Desai SR, Maher TM, Renzoni EA, Wells AU, Higginson IJ, Birring SS. The development and validation of the King's Brief Interstitial Lung Disease (K-BILD) health status questionnaire. Thorax. 2012 Sep;67(9):804-10. doi: 10.1136/thoraxjnl-2012-201581. Epub 2012 May 3.

  PMID: 22555278 BACKGROUND

• Van Remoortel H, Raste Y, Louvaris Z, Giavedoni S, Burtin C, Langer D, Wilson F, Rabinovich R, Vogiatzis I, Hopkinson NS, Troosters T; PROactive consortium. Validity of six activity monitors in chronic obstructive pulmonary disease: a comparison with indirect calorimetry. PLoS One. 2012;7(6):e39198. doi: 10.1371/journal.pone.0039198. Epub 2012 Jun 20.

  PMID: 22745715 BACKGROUND

• Terwee CB, Prinsen CAC, Chiarotto A, Westerman MJ, Patrick DL, Alonso J, Bouter LM, de Vet HCW, Mokkink LB. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res. 2018 May;27(5):1159-1170. doi: 10.1007/s11136-018-1829-0. Epub 2018 Mar 17.

  PMID: 29550964 BACKGROUND

• Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, Burroughs H, Jinks C. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi: 10.1007/s11135-017-0574-8. Epub 2017 Sep 14.

  PMID: 29937585 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alda S. Marques, PhD

  School of Health Sciences of the University of Aveiro (ESSUA)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alda S. Marques, PhD

CONTACT

00351 234 372 462; amarques@ua.pt

Odete M. Alves, MSc

CONTACT

00351 234 372 476; odete.alves@ua.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 19, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)