Glittre ADL-test: Responsiveness to Acute Bronchodilation in Chronic Obstructive Pulmonary Disease (COPD)

NCT03071731 | Unknown DMC

• 1 other identifier: 2017-2739
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This project is aimed to assess the responsiveness of the Glittre ADL-test and the 1-Minute Sit-to-Stand test (1-Minute STST) to acute bronchodilation in patients with COPD. We also aim to investigate the physiological and perceptual response to bronchodilation of the Glittre ADL-test and the 1-minute STST. The specific objectives are 1)To measure the changes in time for completion of the Glittre ADL-test and the number of standing up during the 1-minute STST induced by a single dose of nebulized ipratropium bromide/salbutamol sulfate against those induced by a placebo in patients with moderate to severe COPD and 2)To compare in patients with moderate to severe COPD the CR (minute ventilation (VE), oxygen uptake (VO2), carbon dioxide production (VCO2) and heart rate) and symptomatic (dyspnea and leg fatigue perception) responses during the Glittre ADL-test and the 1-Minute STST following a single dose of ipratropium bromide/salbutamol sulfate or placebo. We suppose among others that the Glittre test completion time will be lesser, that the number of repetitions in the 1-Minute STST will be higher and symptoms intensity will be lesser among patients with COPD receiving bronchodilators.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Glittre; COPD; sit-to-stand; responsiveness; bronchodilation

Outcome Measures

Primary Outcomes (1)

• Glittre ADL-test time completion

  Time to complete 5 laps as fast as possible

  Between 2 and 12 minutes for each test; up to three days between the two tests

Secondary Outcomes (21)

• Perceptual variables

  Up to three days between the two administrations

• Perceptual variables

  Up to three days between the two administrations

• Breathing discomfort

  Up to three days between the two administrations

• Breathing discomfort

  Up to three days between the two administrations

• Accelerometry-subduration

  Up to three days between the two administrations

Study Arms (2)

Bronchodilators

EXPERIMENTAL

Nebulization of ipratropium bromide/salbutamol sulfate (500 µg/2.5 mg) before the administration of the Glittre ADL-test

Drug: Bronchodilators; Drug: Placebos

Placebo

PLACEBO COMPARATOR

Nebulization of a placebo before the administration of the Glittre ADL-test

Drug: Bronchodilators; Drug: Placebos

Interventions

Bronchodilators DRUG

Administration of a nebulized combination of bronchodilators before the administration of a functional test.

Also known as: ipratropium bromide; salbutamol sulfate

Bronchodilators; Placebo

Placebos DRUG

Administration of a nebulized placebo before the administration of a functional test

Also known as: nebulized placebo

Bronchodilators; Placebo

Eligibility Criteria

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

You may qualify if:

• Diagnosis of moderate to severe COPD based on the GOLD spirometric classification
• able to provide written informed consent
• able to follow verbal directions for testing.

You may not qualify if:

• diagnosed with cardiovascular, neurological or, neuromuscular conditions that could affect ability to perform the tests (e.g. stroke, knee osteoarthritis);
• currently participating in a structured exercise or pulmonary rehabilitation program or been involved in pulmonary rehabilitation in the past 6 months;
• experienced a COPD exacerbation in the past 6 weeks
• receiving a daily dose \> 10mg of oral Prednisone within the past 3 months
• unable to walk 4 metres without use of a gait aid (e.g. walker, cane)
• receiving oxygen supply

Sponsors & Collaborators

• Laval University: lead
• Institut universitaire de cardiologie et de pneumologie de Québec, University Laval: collaborator

Study Sites (1)

Centre de recherche-Institut Universitaire de Cardiologie et Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

RECRUITING

Related Publications (12)

• Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. doi: 10.1164/rccm.200703-456SO. Epub 2007 May 16.

  PMID: 17507545 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

• Velloso M, Stella SG, Cendon S, Silva AC, Jardim JR. Metabolic and ventilatory parameters of four activities of daily living accomplished with arms in COPD patients. Chest. 2003 Apr;123(4):1047-53. doi: 10.1378/chest.123.4.1047.

  PMID: 12684292 BACKGROUND

• Annegarn J, Meijer K, Passos VL, Stute K, Wiechert J, Savelberg HH, Schols AM, Wouters EF, Spruit MA; Ciro+ Rehabilitation Network. Problematic activities of daily life are weakly associated with clinical characteristics in COPD. J Am Med Dir Assoc. 2012 Mar;13(3):284-90. doi: 10.1016/j.jamda.2011.01.002. Epub 2011 Feb 17.

  PMID: 21450242 BACKGROUND

• Skumlien S, Hagelund T, Bjortuft O, Ryg MS. A field test of functional status as performance of activities of daily living in COPD patients. Respir Med. 2006 Feb;100(2):316-23. doi: 10.1016/j.rmed.2005.04.022. Epub 2005 Jun 6.

  PMID: 15941658 BACKGROUND

• Karloh M, Karsten M, Pissaia FV, de Araujo CL, Mayer AF. Physiological responses to the Glittre-ADL test in patients with chronic obstructive pulmonary disease. J Rehabil Med. 2014 Jan;46(1):88-94. doi: 10.2340/16501977-1217.

  PMID: 24104462 BACKGROUND

• Correa KS, Karloh M, Martins LQ, dos Santos K, Mayer AF. Can the Glittre ADL test differentiate the functional capacity of COPD patients from that of healthy subjects? Rev Bras Fisioter. 2011 Nov-Dec;15(6):467-73. doi: 10.1590/s1413-35552011005000034. Epub 2011 Nov 21. English, Portuguese.

  PMID: 22094546 BACKGROUND

• Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.

  PMID: 22878278 BACKGROUND

• Standardization of Spirometry, 1994 Update. American Thoracic Society. Am J Respir Crit Care Med. 1995 Sep;152(3):1107-36. doi: 10.1164/ajrccm.152.3.7663792. No abstract available.

  PMID: 7663792 BACKGROUND

• Ribeiro F, Lepine PA, Garceau-Bolduc C, Coats V, Allard E, Maltais F, Saey D. Test-retest reliability of lower limb isokinetic endurance in COPD: A comparison of angular velocities. Int J Chron Obstruct Pulmon Dis. 2015 Jun 18;10:1163-72. doi: 10.2147/COPD.S81806. eCollection 2015.

  PMID: 26124656 BACKGROUND

• Langer D, Gosselink R, Sena R, Burtin C, Decramer M, Troosters T. Validation of two activity monitors in patients with COPD. Thorax. 2009 Jul;64(7):641-2. doi: 10.1136/thx.2008.112102. No abstract available.

  PMID: 19561287 BACKGROUND

• Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

  PMID: 7154893 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Bronchodilator Agents; Ipratropium; Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• Didier Saey, Ph.D.

  Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kim-Ly Bui, M.pht

CONTACT

418-656-8711; kim-ly.bui@criucpq.ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization to decide on which visit the participant will receive the placebo will be generated by a software and managed by the main investigator. Bronchodilators and the placebo will be put in an aerosol of same shape and color so the participants and outcomes assessor won't be able to tell which one is which.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher-Associate Professor

Model Details: Participants receive one intervention (bronchodilation before performing a functional test) during the initial phase of the study and during the second phase of the study are evaluated in parallel after receiving a placebo or vice versa (random order)

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: March 7, 2017
• Study Start: April 13, 2017
• Primary Completion: June 15, 2019
• Study Completion: June 15, 2019
• Last Updated: July 6, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)