Recruiting

Glittre ADL-test

Sponsor:

Laval University

Code:

NCT03071731

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Bronchodilators

Placebos

Study Details

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

Study ID

NCT03071731

Start date

Apr 13, 2017

Status verified date

Jul, 2018

Completion date

Jun 15, 2019

Anticipated

Primary completion date

Jun 15, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Design

Enrollment

34 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Bronchodilators

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

placebo comparator: Placebo

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

Interventions

Bronchodilators

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

Placebos

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

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 ]

Central Contacts and Locations

Central contacts

Locations

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

Recruiting

Quebec City, Quebec, Canada, G1V4G5

Contacts

More Information

Sponsor

Laval University

Last update posted

Jul 6, 2018

Last verified

Jul, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2018-07-06.