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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

Determination of Minimal Important Difference for the Glittre-ADL Test and London Chest Activity of Daily Living Scale in Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251781
• Other study ID #: 222/2011
• Secondary ID: 063053/2014
• Status: Completed
• Phase: N/A
• Start date: April 1, 2013
• Est. completion date: November 30, 2017

Study information

• Verified date: September 2018
• Source: University of the State of Santa Catarina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: November 30, 2017
• Est. primary completion date: May 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Pulmonary Rehabilitation
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.

Locations

Country	Name	City	State
Brazil	University of the State of Santa Catarina	Florianópolis	Santa Catarina
Brazil	Universidade Federal de Ciências da Saúde de Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
University of the State of Santa Catarina	Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. English, Portuguese. — View 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. — View 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. Review. — View 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. — View 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. English, Portuguese. — View 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. — View 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. — View 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 Mölken 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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	Six-minute walking test	Change in six-minute walking test performance	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).
Secondary	Modified Medical Research Council	Change in Modified Medical Research Council score	The change in the Modified Medical Research Council score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).
Secondary	COPD Assessment Test (CAT)	Change in COPD Assessment Test (CAT) score	The change in the COPD Assessment Test (CAT) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).
Secondary	Saint George Respiratory Questionnaire (SGRQ)	Change in Saint George Respiratory Questionnaire (SGRQ) score	The change in the Saint George Respiratory Questionnaire (SGRQ) score from baseline up to 24 pulmonary rehabilitation session (8 weeks of pulmonary rehabilitation).