Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale

NCT03251781 | Completed

• 2 other identifiers: 222/2011063053/2014
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

Background: The ability to perform activities of daily living (ADL) in patients with chronic obstructive pulmonary disease is often impaired. Glittre-ADL Test has been used to assess limitations in ADL, and it seems to be responsive to intervention. However, the minimal detectable change for Glittre-ADL Test remains unknown. Design: Non-controlled before and after study. Setting: The study will be conducted in an outpatient pulmonary rehabilitation program in Florianopolis, Brazil. Subjects: Patients with COPD (GOLD II-IV). Interventions: Pulmonary rehabilitation program based on physical training, conducted over 24 sessions supervised, three times a week, including aerobic training in treadmill and localized training for upper limbs and lower limbs. Main measures: Glittre ADL-Test performance, six-minute walk test performance, London Chest Activity of Daily Living score, Modified Medical Research Council score, COPD Assessment Test score, Saint George Respiratory Questionnaire score before and after the pulmonary rehabilitation program.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Minimal Clinically Important Difference; Exercise Test; Rehabilitation; Disability Evaluation

Outcome Measures

Primary Outcomes (2)

• Glittre ADL-Test

  Change in Glittre ADL-Test performance

  The change in the Glittre ADL-test performance from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).

• London Chest Activity of Daily Living

  Change in London Chest Activity of Daily Living score

  The change in the London Chest Activity of Daily Living score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).

Secondary Outcomes (4)

• Six-minute walking test

  The change in the distance walked during the six-minute walking test from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).

• Modified Medical Research Council

  The change in the Modified Medical Research Council score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).

• COPD Assessment Test (CAT)

  The change in the COPD Assessment Test (CAT) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).

• Saint George Respiratory Questionnaire (SGRQ)

  The change in the Saint George Respiratory Questionnaire (SGRQ) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).

Study Arms (1)

Pulmonary Rehabilitation

EXPERIMENTAL

Pulmonary Rehabilitation

Other: Pulmonary Rehabilitation

Interventions

Pulmonary Rehabilitation OTHER

Pulmonary rehabilitation program (PRP) was conducted according to the guidelines of the American Thoracic Society/European Respiratory Society (Nici et al., 2006; Spruit et al., 2013). Physical training was conducted over 24 sessions supervised, three times a week. The program included aerobic training in treadmill (with 30 min load determined by the dyspnea sensation - 4 to 6 on the modified Borg scale) and localized training for upper limbs with free weights or elastic bands (movements performed based on the proprioceptive neuromuscular facilitation diagonals, performed in two series, lasting two minutes each) and lower limbs (quadriceps and triceps sural) with free weights and/or in the bodybuilding station.

Pulmonary Rehabilitation

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of COPD confirmed by spirometry (COPD GOLD stages II, III and IV)
• Absence of change in respiratory symptoms in the past four weeks
• No hospital admission in the past 12 weeks
• Age between 40 and 80 years old

You may not qualify if:

• Any other disease or health condition that could compromise the test´s execution or physical training
• Participation in pulmonary rehabilitation program completed in the last six months
• Interruption of pulmonary rehabilitation program for any reason
• Current smoking or its cessation in less than six months
• Any change in symptoms during the study protocol assessments

Sponsors & Collaborators

• University of the State of Santa Catarina: lead
• Federal University of Health Science of Porto Alegre: collaborator

Study Sites (2)

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

Location

University of the State of Santa Catarina

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

Related Publications (10)

• Nici L, Donner C, Wouters E, Zuwallack R, Ambrosino N, Bourbeau J, Carone M, Celli B, Engelen M, Fahy B, Garvey C, Goldstein R, Gosselink R, Lareau S, MacIntyre N, Maltais F, Morgan M, O'Donnell D, Prefault C, Reardon J, Rochester C, Schols A, Singh S, Troosters T; ATS/ERS Pulmonary Rehabilitation Writing Committee. American Thoracic Society/European Respiratory Society statement on pulmonary rehabilitation. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1390-413. doi: 10.1164/rccm.200508-1211ST. No abstract available.

  PMID: 16760357 BACKGROUND

• Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.

  PMID: 24127811 BACKGROUND

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 BACKGROUND

• Garrod R, Bestall JC, Paul EA, Wedzicha JA, Jones PW. Development and validation of a standardized measure of activity of daily living in patients with severe COPD: the London Chest Activity of Daily Living scale (LCADL). Respir Med. 2000 Jun;94(6):589-96. doi: 10.1053/rmed.2000.0786.

  PMID: 10921765 BACKGROUND

• Carpes MF, Mayer AF, Simon KM, Jardim JR, Garrod R. The Brazilian Portuguese version of the London Chest Activity of Daily Living scale for use in patients with chronic obstructive pulmonary disease. J Bras Pneumol. 2008 Mar;34(3):143-51. doi: 10.1590/s1806-37132008000300004. English, Portuguese.

  PMID: 18392462 BACKGROUND

• Kovelis D, Segretti NO, Probst VS, Lareau SC, Brunetto AF, Pitta F. Validation of the Modified Pulmonary Functional Status and Dyspnea Questionnaire and the Medical Research Council scale for use in Brazilian patients with chronic obstructive pulmonary disease. J Bras Pneumol. 2008 Dec;34(12):1008-18. doi: 10.1590/s1806-37132008001200005. English, Portuguese.

  PMID: 19180335 BACKGROUND

• Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J. 2009 Sep;34(3):648-54. doi: 10.1183/09031936.00102509.

  PMID: 19720809 BACKGROUND

• Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

  PMID: 25359355 BACKGROUND

• Almeida Gulart A, de Araujo CLP, Bauer Munari A, Schneider BF, Dal Lago P, Mayer AF. Minimal important difference for London Chest Activity of Daily Living scale in patients with chronic obstructive pulmonary disease. Physiotherapy. 2020 Jun;107:28-35. doi: 10.1016/j.physio.2019.08.007. Epub 2019 Aug 9.

  PMID: 32026830 DERIVED

• Gulart AA, Araujo CLP, Munari AB, Santos KD, Karloh M, Foscarini BG, Dal Lago P, Mayer AF. The minimal important difference for Glittre-ADL test in patients with chronic obstructive pulmonary disease. Braz J Phys Ther. 2020 Jan-Feb;24(1):54-60. doi: 10.1016/j.bjpt.2018.11.009. Epub 2018 Nov 20.

  PMID: 30497829 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anamaria F Mayer, PhD

  University of the State of Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 16, 2017
• Study Start: April 1, 2013
• Primary Completion: May 31, 2017
• Study Completion: November 30, 2017
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)