Chronic Obstructive Pulmonary DiseaseGlittreNCT03071731
Glittre ADL-test: Responsiveness to Acute Bronchodilation in Chronic Obstructive Pulmonary Disease (COPD)
A study testing Bronchodilators in people with Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bronchodilators
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 13 Apr 2017to 15 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche-Institut Universitaire de Cardiologie et Pneumologie de Québec
Québec, Quebec, G1V4G5
Kim-Ly Bui, M.pht, 418-656-8711 ext. 2713, kim-ly.bui@criucpq.ulaval.ca
Didier Saey, Ph.D., 418-656-8711 ext. 2614, didier.saey@rea.ulaval.ca
About this study
Official title: Glittre Activities of Daily Life-test: Responsiveness to Acute Bronchodilation in Chronic Obstructive Pulmonary Disease (COPD)
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.
Read the detailed description
METHODOLOGY: Study design and setting: It will be a randomized double-blind trial during which 34 patients with moderate to severe COPD will complete 2 Glittre ADL-tests 15 minutes following nebulization of a placebo or of ipratropium bromide/salbutamol sulfate combination. Patients receiving bronchodilators before the beginning of the study will be asked to withdraw from their medication 8h in the case of short-acting bronchodilators and/or 72 h in the case of long-acting bronchodilators before visits. Those treated with tiotropium will have a 4-week washout period during which this therapy will be replaced by ipratropium bromide. The study will require 3 visits to the research center of Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval (IUCPQ). The 1st visit will be devoted to verify the eligibility to the study, obtain informed consent, and measure baseline characteristic including anthropometric measurements, pulmonary, and lower limb muscle function, as well maximal exercise capacity and participation in activities of daily life. In addition, participants will be familiarized with the Glittre test. During the following visits, subjects will complete two Glittre tests (1/visit) preceded by administration of nebulized placebo or ipratropium bromide/salbutamol sulfate (500 mg/2.5 mg) administrated in a randomized and double-blind fashion. Study visits will be separated by >72 h and <7 days. Subjects will be scheduled to attend at the same time of day throughout the study. Ethics approval will be obtained before starting the project and all subjects will provide written informed consent prior to testing. Procedure and measurements: Anthropometric measurements: Weight and height will be measured on a standing scale. Pulmonary function: Complete pulmonary function tests including spirometry, lung volumes and diffusing capacity for carbon monoxide will be obtained according to standardized technique and expressed as a percent of predicted9. In addition, during visit 2 and 3, a spirometry (FEV1 and FVC) will be obtained before and after bronchodilation to determine bronchodilator-induced change in FEV1 and baseline respiratory condition before functional tests. Muscle function: Quadriceps muscle function (force, endurance and fatigue) will be quantified during a knee extension test. The test will consist of one set of 30 repetitions at an angular velocity of 90°/s. Amplitude and angular velocity will be controlled using a dynamometric isokinetic system (Biodex, system pro 4, Biodex Medical System, Shirley, NY, USA). Maximal exercise capacity: Maximal exercise capacity will be assessed using a symptom-limited incremental cycling test. Subjects will be seating on an electrically braked ergocycle (Quinton Corival 400; A-H Robins, Seattle, WA) and connected to a portable a gas analysis system (Oxycon Mobile, Viasys Healthcare, Jaeger, Germany). After 5 minutes of rest, a progressive stepwise exercise test will be performed up to the individual maximal capacity. Each exercise step lasts 1 minute and increments of 10 watts will be applied. Minute ventilation (VE), oxygen uptake (VO2), and CO2 excretion (VCO2) respiratory exchange ratio (RER), respiratory rate (RR) inspiratory capacity (IC) and heart rate (HR) will be measured at rest and during exercise on a breath-by-breath basis. In addition, pulsed oxygen saturation (SpO2) will be measured at rest, continuously during the tests, and at end-exercise by pulse oximetry (OSM2 Hemoximeter; Radiometer,Copenhagen, Denmark). Dyspnea and leg fatigue perception will be measured by a modified Borg scale at rest, each 2 minutes and at the end of exercise. Participation in activities of daily life: Participation in activities of daily life will be measured with an accelerometer-based activity monitor (DynaPort Minimod, McRoberts BV, The Hague, The Netherlands). Patients will be instructed to wear the monitor on the waist for 7 consecutive days. They will also fill a diary of activities through the week they are wearing the physical activity monitor. Self-efficacy: Patients' perceived walking and climbing stairs confidence (on flat ground, with and without handrail) will be assessed with the 10-item self-report modified Gait Efficacy Scale. Functional tests: The Glittre ADL tests will be completed according to the original procedure described by Skumlien5. Briefly, patient carrying a weighted backpack (2.5 kg for women, 5.0 kg for men) will be instructed to stand up and walk along a flat 10-m long course. In the middle of the course, there will be a 2-step staircase (each step 17 cm high×27 cm deep) to get across. After completing the second 5 m, the subject will be facing a shelf containing 3 objects, each weighing 1 kg, positioned on the top shelf (shoulder height). Participants will then move objects, 1 by 1, to the bottom shelf (waist height) and then to the floor. Once completed, participants will then have to return the objects, always 1 by 1, to the bottom shelf and finally to the top shelf again. Participants will then walk back along the circuit, climbing and descending the stairs, until reaching the starting point (chair); sitting down and immediately beginning the next lap. Patients will be instructed to complete 5 laps on this circuit as quickly as possible. The 1-minute STST will be completed according to the procedure described by Ozalevli and al. Patients will be instructed to fully stand up from a chair, arms across the chest, sit back down and repeat as often as possible during one minute. Physiological measures as well as dyspnea and leg fatigue perception will be acquired with the same methodology used for the maximal exercise capacity. The order of functional tests will be randomized for each patient. Patients will also fill the Multidimensional Dyspnea Profile questionnaire. Global rating of change: Patients' perception of change in their performance, dyspnea and leg fatigue induced by the functional tests will be ascertain with a 7-point Likert Scale ranging from -3 (large deterioration) to +3 (large improvement) immediately after each functional test. No feedback from the evaluator will be given to patients before patients' own rating.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Bronchodilators, Placebos
- Keywords
- Glittre, COPD, sit-to-stand, responsiveness, bronchodilation
- 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.
BronchodilatorsDrug
Also called ipratropium bromide; salbutamol sulfate
Administration of a nebulized combination of bronchodilators before the administration of a functional test.
PlacebosDrug
Also called nebulized placebo
Administration of a nebulized placebo before the administration of a functional test
| Study group | Role | What they receive |
|---|---|---|
| Bronchodilators | Experimental | Nebulization of ipratropium bromide/salbutamol sulfate (500 µg/2.5 mg) before the administration of the Glittre ADL-test Receives: Drug: Bronchodilators; Drug: Placebos |
| Placebo | Placebo comparator | Nebulization of a placebo before the administration of the Glittre ADL-test Receives: Drug: Bronchodilators; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glittre ADL-test time completion
Time to complete 5 laps as fast as possible
Measured: Between 2 and 12 minutes for each test; up to three days between the two tests
Secondary outcomes (21)
Perceptual variables
Dyspnea and fatigue in the legs at the end of the Glittre ADL-test
Measured: Up to three days between the two administrations
Perceptual variables
Dyspnea and fatigue in the legs at the end of the 1-minute STST
Measured: Up to three days between the two administrations
Breathing discomfort
Overall subjective experience of breathing discomfort after the Glittre ADL-test assessed with the Multidimensional Dyspnea Profile questionnaire
Measured: Up to three days between the two administrations
Breathing discomfort
Overall subjective experience of breathing discomfort after the 1-minute STST assessed with the Multidimensional Dyspnea Profile questionnaire
Measured: Up to three days between the two administrations
Accelerometry-subduration
Subduration (in seconds) in the Glittre ADL-test for each component, in each lap
Measured: Up to three days between the two administrations
Accelerometry-steps
Number of steps in the Glittre ADL-test for each walking section, in each lap
Measured: Up to three days between the two administrations
Accelerometry
Vertical and horizontal acceleration and deceleration (m/s) in the Glittre ADL-test for each component, in each lap
Measured: Up to three days between the two administrations
Accelerometry
Vertical and horizontal acceleration and deceleration (m/s) in the 1-minute STST for each repetition.
Measured: Up to three days between the two administrations
Hyperinflation
Change of IC between the beginning and end of the Glittre ADL-test completed after the administration of the placebo compared with the change of IC between the beginning and end of the Glittre test after the administration of the combination of bronchodilators
Measured: Between 2 and 12 minutes for the IC measures at the beginning and at the end of the Glittre test, and up to 3 days before the 2nd assessment
Hyperinflation
Change of IC between the beginning and end of the 1-minute STST completed after the administration of the placebo compared with the change of IC between the beginning and end of the 1-minute STST after the administration of the combination of bronchodilators
Measured: In a 5-minute time frame for the IC measures at the beginning and at the end of the 1-minute STST, and up to 3 days before the 2nd assessment
Physiological variable-ventilation
Minute ventilation (VE; L/min) during the two Glittre ADL-test compared to the VE during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variable-ventilation
Minute ventilation (VE; L/min) during the two 1-minute STST compared to the VE during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Physiological variable-ratio exchange rate
Ratio exchange rate (RER) the two Glittre ADL-tests compared to RER during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variable-ratio exchange rate
Ratio exchange rate (RER) the two 1-minute STST compared to RER during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Physiological variables-VO2 and VCO2
VO2 and VCO2 during the two Glittre ADL-tests compared to those during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variables-VO2 and VCO2
VO2 and VCO2 during the two 1-minute STST compared to those during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Physiological variable-HR
Peak Heart rate (HR; beats/minute) during the two Glittre ADL-test compared to peak heart rate during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variable-HR
Peak Heart rate (HR; beats/minute) during the two 1-minute STST compared to peak heart rate during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Physiological variable-RR
Peak respiratory rate (breaths/min) during the two Glittre ADL-test compared to peak heart rate during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variable-RR
Peak respiratory rate (breaths/min) during the two 1-minute STST compared to peak heart rate during an incremental cardiopulmonary maximal exercise test on bike.
Measured: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Number of repetitions 1-Minute STST
Number of full stand-up repetitions in the 1-Minute STST in both conditions (following the administration of the placebo and the bronchodilators)
Measured: About 2-3 minutes for test administration including instructions and demonstration; up to 3 days between both administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start13 Apr 2017
- Primary completion15 Jun 2019 (estimated)
- Study completion15 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Responsible party
- Principal investigator, Didier Saey, Laval University
- Investigators
- Didier Saey, Ph.D., Principal investigator, Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071731
- Sponsor's protocol ID
- 2017-2739
- Acronym
- Glittre
- Status last verified
- Jul 2018
- First submitted
- 16 Feb 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data sets on characterization (muscle and pulmonary function, cardiopulmonary exercise testing) and medical history collected during the recruitment interview will be made available to other researchers after the end of the study, upon request. Data will be obtained through electronical denominalized files.
Publications
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.
PubMed 17507545Spruit 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 24127811Velloso 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.
PubMed 12684292Annegarn 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.
PubMed 21450242Skumlien 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.
PubMed 15941658Karloh 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.
PubMed 24104462Correa 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.
PubMed 22094546Vestbo 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.
PubMed 22878278Standardization 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.
PubMed 7663792Ribeiro 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.
PubMed 26124656Langer 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.
PubMed 19561287Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glittre Activities of Daily Life-test: Responsiveness to Acute Bronchodilation in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT03071731
- Acronym / sponsor ID
- Glittre / 2017-2739
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Glittre, COPD, sit-to-stand, responsiveness, bronchodilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
- Study start
- 13 Apr 2017 (actual)
- Primary completion
- 15 Jun 2019 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 7 Mar 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.
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.
Detailed description
METHODOLOGY: Study design and setting: It will be a randomized double-blind trial during which 34 patients with moderate to severe COPD will complete 2 Glittre ADL-tests 15 minutes following nebulization of a placebo or of ipratropium bromide/salbutamol sulfate combination. Patients receiving bronchodilators before the beginning of the study will be asked to withdraw from their medication 8h in the case of short-acting bronchodilators and/or 72 h in the case of long-acting bronchodilators before visits. Those treated with tiotropium will have a 4-week washout period during which this therapy will be replaced by ipratropium bromide. The study will require 3 visits to the research center of Institut Universitaire de Cardiologie et de Pneumologie de Québec-Université Laval (IUCPQ). The 1st visit will be devoted to verify the eligibility to the study, obtain informed consent, and measure baseline characteristic including anthropometric measurements, pulmonary, and lower limb muscle function, as well maximal exercise capacity and participation in activities of daily life. In addition, participants will be familiarized with the Glittre test. During the following visits, subjects will complete two Glittre tests (1/visit) preceded by administration of nebulized placebo or ipratropium bromide/salbutamol sulfate (500 mg/2.5 mg) administrated in a randomized and double-blind fashion. Study visits will be separated by >72 h and <7 days. Subjects will be scheduled to attend at the same time of day throughout the study. Ethics approval will be obtained before starting the project and all subjects will provide written informed consent prior to testing. Procedure and measurements: Anthropometric measurements: Weight and height will be measured on a standing scale. Pulmonary function: Complete pulmonary function tests including spirometry, lung volumes and diffusing capacity for carbon monoxide will be obtained according to standardized technique and expressed as a percent of predicted9. In addition, during visit 2 and 3, a spirometry (FEV1 and FVC) will be obtained before and after bronchodilation to determine bronchodilator-induced change in FEV1 and baseline respiratory condition before functional tests. Muscle function: Quadriceps muscle function (force, endurance and fatigue) will be quantified during a knee extension test. The test will consist of one set of 30 repetitions at an angular velocity of 90°/s. Amplitude and angular velocity will be controlled using a dynamometric isokinetic system (Biodex, system pro 4, Biodex Medical System, Shirley, NY, USA). Maximal exercise capacity: Maximal exercise capacity will be assessed using a symptom-limited incremental cycling test. Subjects will be seating on an electrically braked ergocycle (Quinton Corival 400; A-H Robins, Seattle, WA) and connected to a portable a gas analysis system (Oxycon Mobile, Viasys Healthcare, Jaeger, Germany). After 5 minutes of rest, a progressive stepwise exercise test will be performed up to the individual maximal capacity. Each exercise step lasts 1 minute and increments of 10 watts will be applied. Minute ventilation (VE), oxygen uptake (VO2), and CO2 excretion (VCO2) respiratory exchange ratio (RER), respiratory rate (RR) inspiratory capacity (IC) and heart rate (HR) will be measured at rest and during exercise on a breath-by-breath basis. In addition, pulsed oxygen saturation (SpO2) will be measured at rest, continuously during the tests, and at end-exercise by pulse oximetry (OSM2 Hemoximeter; Radiometer,Copenhagen, Denmark). Dyspnea and leg fatigue perception will be measured by a modified Borg scale at rest, each 2 minutes and at the end of exercise. Participation in activities of daily life: Participation in activities of daily life will be measured with an accelerometer-based activity monitor (DynaPort Minimod, McRoberts BV, The Hague, The Netherlands). Patients will be instructed to wear the monitor on the waist for 7 consecutive days. They will also fill a diary of activities through the week they are wearing the physical activity monitor. Self-efficacy: Patients' perceived walking and climbing stairs confidence (on flat ground, with and without handrail) will be assessed with the 10-item self-report modified Gait Efficacy Scale. Functional tests: The Glittre ADL tests will be completed according to the original procedure described by Skumlien5. Briefly, patient carrying a weighted backpack (2.5 kg for women, 5.0 kg for men) will be instructed to stand up and walk along a flat 10-m long course. In the middle of the course, there will be a 2-step staircase (each step 17 cm high×27 cm deep) to get across. After completing the second 5 m, the subject will be facing a shelf containing 3 objects, each weighing 1 kg, positioned on the top shelf (shoulder height). Participants will then move objects, 1 by 1, to the bottom shelf (waist height) and then to the floor. Once completed, participants will then have to return the objects, always 1 by 1, to the bottom shelf and finally to the top shelf again. Participants will then walk back along the circuit, climbing and descending the stairs, until reaching the starting point (chair); sitting down and immediately beginning the next lap. Patients will be instructed to complete 5 laps on this circuit as quickly as possible. The 1-minute STST will be completed according to the procedure described by Ozalevli and al. Patients will be instructed to fully stand up from a chair, arms across the chest, sit back down and repeat as often as possible during one minute. Physiological measures as well as dyspnea and leg fatigue perception will be acquired with the same methodology used for the maximal exercise capacity. The order of functional tests will be randomized for each patient. Patients will also fill the Multidimensional Dyspnea Profile questionnaire. Global rating of change: Patients' perception of change in their performance, dyspnea and leg fatigue induced by the functional tests will be ascertain with a 7-point Likert Scale ranging from -3 (large deterioration) to +3 (large improvement) immediately after each functional test. No feedback from the evaluator will be given to patients before patients' own rating.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Bronchodilators | Experimental | Drug: Bronchodilators, Drug: PlacebosNebulization of ipratropium bromide/salbutamol sulfate (500 µg/2.5 mg) before the administration of the Glittre ADL-test |
| Placebo | Placebo comparator | Drug: Bronchodilators, Drug: PlacebosNebulization of a placebo before the administration of the Glittre ADL-test |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| BronchodilatorsAlso: ipratropium bromide; salbutamol sulfateAdministration of a nebulized combination of bronchodilators before the administration of a functional test. | Drug | Bronchodilators, Placebo |
| PlacebosAlso: nebulized placeboAdministration of a nebulized placebo before the administration of a functional test | Drug | Bronchodilators, Placebo |
Primary outcome
Glittre ADL-test time completion
Time frame: Between 2 and 12 minutes for each test; up to three days between the two tests
Time to complete 5 laps as fast as possible
21 secondary outcomes
Perceptual variables
Time frame: Up to three days between the two administrations
Perceptual variables
Time frame: Up to three days between the two administrations
Breathing discomfort
Time frame: Up to three days between the two administrations
Breathing discomfort
Time frame: Up to three days between the two administrations
Accelerometry-subduration
Time frame: Up to three days between the two administrations
Accelerometry-steps
Time frame: Up to three days between the two administrations
Accelerometry
Time frame: Up to three days between the two administrations
Accelerometry
Time frame: Up to three days between the two administrations
Hyperinflation
Time frame: Between 2 and 12 minutes for the IC measures at the beginning and at the end of the Glittre test, and up to 3 days before the 2nd assessment
Hyperinflation
Time frame: In a 5-minute time frame for the IC measures at the beginning and at the end of the 1-minute STST, and up to 3 days before the 2nd assessment
Physiological variable-ventilation
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variable-ventilation
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Physiological variable-ratio exchange rate
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variable-ratio exchange rate
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Physiological variables-VO2 and VCO2
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variables-VO2 and VCO2
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Physiological variable-HR
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variable-HR
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Physiological variable-RR
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first Glittre ADL-test, and up to 13 days between the test on the bike and the 2nd Glittre ADL-test
Physiological variable-RR
Time frame: Up to 10 days between the cardiopulmonary maximal exercise test on the bike and the first 1-minute STST, and up to 13 days between the test on the bike and the 2nd 1-minute STST
Number of repetitions 1-Minute STST
Time frame: About 2-3 minutes for test administration including instructions and demonstration; up to 3 days between both administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Background: PubMed 17507545Rabe 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.
- 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 12684292Velloso 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.
- Background: PubMed 21450242Annegarn 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.
- Background: PubMed 15941658Skumlien 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.
- Background: PubMed 24104462Karloh 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.
- Background: PubMed 22094546Correa 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.
- Background: PubMed 22878278Vestbo 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.
- Background: PubMed 7663792Standardization 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.
- Background: PubMed 26124656Ribeiro 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.
- Background: PubMed 19561287Langer 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.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Individual participant dataSharing planned: Yes. Participant data sets on characterization (muscle and pulmonary function, cardiopulmonary exercise testing) and medical history collected during the recruitment interview will be made available to other researchers after the end of the study, upon request. Data will be obtained through electronical denominalized files.
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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.
Didier Saey, Ph.D. principal investigator
Centre de recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchodilators in people with Chronic Obstructive Pulmonary Disease, run by Laval University at 1 site in Canada.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kim-Ly Bui, M.pht (418-656-8711 ext. 2713, kim-ly.bui@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glittre ADL-test time completion (time frame: Between 2 and 12 minutes for each test; up to three days between the two tests). 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 NCT03071731, which also lists 12 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 6 Jul 2018.