Pulmonary Disease, Chronic ObstructiveNCT03251781
Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale
A study testing Pulmonary Rehabilitation in people with Pulmonary Disease, Chronic Obstructive, run by University of the State of Santa Catarina at 2 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Apr 2013to 30 Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
University of the State of Santa Catarina
Florianópolis, Santa Catarina, 88080-350
Universidade Federal de Ciências da Saúde de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
About this study
Official title: Determination of Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale in Patients With COPD
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Pulmonary Rehabilitation
- Keywords
- Minimal Clinically Important Difference, Exercise Test, Rehabilitation, Disability Evaluation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehabilitation | Experimental | Pulmonary Rehabilitation Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glittre ADL-Test
Change in Glittre ADL-Test performance
Measured: 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
Measured: 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
Change in six-minute walking test performance
Measured: 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
Change in Modified Medical Research Council score
Measured: 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)
Change in COPD Assessment Test (CAT) score
Measured: 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)
Change in Saint George Respiratory Questionnaire (SGRQ) score
Measured: The change in the Saint George Respiratory Questionnaire (SGRQ) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start1 Apr 2013
- Primary completion31 May 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Responsible party
- Principal investigator, Prof. Dra. Anamaria Fleig Mayer, University of the State of Santa Catarina
- Investigators
- Anamaria F Mayer, PhD, Principal investigator, University of the State of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251781
- Sponsor's protocol ID
- 222/2011
- Other IDs
- 063053/2014
- Status last verified
- Sep 2018
- First submitted
- 28 Jul 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16760357Spruit 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.
PubMed 24127811Miller 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.
PubMed 16055882Garrod 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.
PubMed 10921765Carpes 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.
PubMed 18392462Kovelis 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.
PubMed 19180335Jones 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.
PubMed 19720809Holland 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.
PubMed 25359355Almeida 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.
PubMed 32026830Gulart 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.
PubMed 30497829
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale in Patients With COPD
- ClinicalTrials.gov ID
- NCT03251781
- Acronym / sponsor ID
- 222/2011
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Minimal Clinically Important Difference, Exercise Test, Rehabilitation, Disability Evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Collaborators
- Federal University of Health Science of Porto Alegre
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation | Experimental | Other: Pulmonary RehabilitationPulmonary Rehabilitation |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary RehabilitationPulmonary 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. | Other | Pulmonary Rehabilitation |
Primary outcome
Glittre ADL-Test
Time frame: The change in the Glittre ADL-test performance from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).
Change in Glittre ADL-Test performance
London Chest Activity of Daily Living
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).
Change in London Chest Activity of Daily Living score
4 secondary outcomes
Six-minute walking test
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).
Modified Medical Research Council
Time frame: 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)
Time frame: 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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Background: PubMed 16760357Nici 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.
- Background: PubMed 24127811Spruit 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.
- Background: PubMed 16055882Miller 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.
- Background: PubMed 10921765Garrod 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.
- Background: PubMed 18392462Carpes 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.
- Background: PubMed 19180335Kovelis 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.
- Background: PubMed 19720809Jones 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.
- Background: PubMed 25359355Holland 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.
- Derived from this study: PubMed 32026830Almeida 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.
- Derived from this study: PubMed 30497829Gulart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anamaria F Mayer, PhD principal investigator
University of the State of Santa Catarina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Pulmonary Disease, Chronic Obstructive, run by University of the State of Santa Catarina at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glittre ADL-Test (time frame: The change in the Glittre ADL-test performance from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03251781, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.