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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
University of the State of Santa Catarina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Minimal Clinically Important Difference, Exercise Test, Rehabilitation, Disability Evaluation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Universidade Federal de Ciências da Saúde de Porto Alegre
  • University of the State of Santa Catarina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pulmonary Rehabilitation

Arm Description

Pulmonary Rehabilitation

Outcomes

Primary Outcome Measures

Glittre ADL-Test
Change in Glittre ADL-Test performance
London Chest Activity of Daily Living
Change in London Chest Activity of Daily Living score

Secondary Outcome Measures

Six-minute walking test
Change in six-minute walking test performance
Modified Medical Research Council
Change in Modified Medical Research Council score
COPD Assessment Test (CAT)
Change in COPD Assessment Test (CAT) score
Saint George Respiratory Questionnaire (SGRQ)
Change in Saint George Respiratory Questionnaire (SGRQ) score

Full Information

First Posted
July 28, 2017
Last Updated
September 6, 2018
Sponsor
University of the State of Santa Catarina
Collaborators
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03251781
Brief Title
Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale
Official Title
Determination of Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale in Patients With COPD
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
November 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the State of Santa Catarina
Collaborators
Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Assigned Interventions: Pulmonary rehabilitation program (PRP) was conducted according to the guidelines of the American Thoracic Society/European Respiratory Society (ATS/ERS). 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 function test: Spirometry will be performed before the PRP, and it will be in accordance with ATS/ERS standards in order to provide the level of pulmonary obstruction and severity of disease. The predicted values will be calculated with the equations derived from Brazilian population. Glittre-ADL Test: The patients will be instructed to complete five laps on the follow circuit as quickly as possible: from a sitting position, the subject stands up and walks along a flat 10-m long course, in the middle of which there is a two-step ladder (each step 17 cm high x 27 cm deep) to be climbed; after completing the 10 m, the subject faces a shelf containing three 1-kg objects positioned on the top shelf (shoulder height) and moves them one by one to the bottom shelf (waist height) and then to the floor; the objects are then returned to the bottom shelf and finally to the top shelf again; the subject walks back, climbing up and down the steps, until reaching the starting point (chair), sits down and immediately begins the next lap. The subjects carry a weighted backpack (2.5 kg for women, 5.0 kg for men). Two Glittre-ADL Tests will be conducted before and after the PRP. Six minute walk test (6MWT): The patients will be instructed to walk in order to perform the largest distance during six minutes. The walking speed will be selected by the patient, according to the guidelines of the ATS. Two 6MWTs will be conducted before and after the PRP. London Chest Activity of Daily Living scale: Patients will be asked about their perception of limitation in activities of daily living, using the London Chest Activity of Daily Living scale (LCADL) before and after the PRP. Modified Medical Research Council scale: Patients will be asked about their perception of dyspnea, using the modified Medical Research Council scale before and after the PRP. Saint George Respiratory Questionnaire: Patients will be asked about their perception of health-related quality of life, using the Saint George Respiratory Questionnaire before and after the PRP. COPD Assessment Test (CAT): Patients will be asked about their perception of the impact of COPD (cough, sputum, dyspnea, and chest tightness) on health status, using CAT before and after the PRP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Minimal Clinically Important Difference, Exercise Test, Rehabilitation, Disability Evaluation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
Pulmonary Rehabilitation
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glittre ADL-Test
Description
Change in Glittre ADL-Test performance
Time Frame
The change in the Glittre ADL-test performance from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).
Title
London Chest Activity of Daily Living
Description
Change in London Chest Activity of Daily Living score
Time Frame
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 Outcome Measure Information:
Title
Six-minute walking test
Description
Change in six-minute walking test performance
Time Frame
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).
Title
Modified Medical Research Council
Description
Change in Modified Medical Research Council score
Time Frame
The change in the Modified Medical Research Council score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).
Title
COPD Assessment Test (CAT)
Description
Change in COPD Assessment Test (CAT) score
Time Frame
The change in the COPD Assessment Test (CAT) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).
Title
Saint George Respiratory Questionnaire (SGRQ)
Description
Change in Saint George Respiratory Questionnaire (SGRQ) score
Time Frame
The change in the Saint George Respiratory Questionnaire (SGRQ) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anamaria F Mayer, PhD
Organizational Affiliation
University of the State of Santa Catarina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Facility Name
University of the State of Santa Catarina
City
Florianópolis
State/Province
Santa Catarina
ZIP/Postal Code
88080-350
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16760357
Citation
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.
Results Reference
background
PubMed Identifier
24127811
Citation
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. Erratum In: Am J Respir Crit Care Med. 2014 Jun 15;189(12):1570.
Results Reference
background
PubMed Identifier
16055882
Citation
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.
Results Reference
background
PubMed Identifier
10921765
Citation
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.
Results Reference
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PubMed Identifier
18392462
Citation
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.
Results Reference
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PubMed Identifier
19180335
Citation
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.
Results Reference
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PubMed Identifier
19720809
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
32026830
Citation
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.
Results Reference
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PubMed Identifier
30497829
Citation
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.
Results Reference
derived

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

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