Copd, Dyspnea, Lung Diseases
Conditions
Keywords
COPD, Menthol, Exercise, Dyspnea
Brief summary
Chronic obstructive pulmonary disease (COPD) is characterised by non-reversible bronchial obstruction associated with systemic disorders and comorbid factors. Dyspnoea is a common symptom among patients with Chronic Obstructive pulmonary Disease (COPD). Dyspnea is the primary symptom limiting exercise and daily activities in these patients. It has been reported that breathing cold air could decrease dyspnoea induced by exercise and could improve exercise performance. The aim of this study is to carry out the effect of cooling sensation induced by menthol chewing-gum on dyspnoea and exercise performance among patients with COPD.
Interventions
OTHERTest with Menthol
patients will perform a Six-minute walk test according to American Thoracic Society guidelines
OTHERTest with placebo
patients will perform a Six-minute walk test according to American Thoracic Society guidelines
Sponsors
Groupe Hospitalier du Havre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* a diagnosis of COPD * Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale) * Clinically stable
Exclusion criteria
* exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise. * exacerbation during the study * Inability to chew or patients with swallowing disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dyspnea after each tests | The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. | Change in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in inspiratory capacity | The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. | Change in inspiratory capacity (Liters) will be measured using a portable spirometer |
| Change in Cardiac Frequency | Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. | Change in Cardiac Frequence (bpm) using a pulse oximetry |
| Change in respiratory rate | Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. | Change in respiratory rate (cycles per minute) will be measured breath-by-breath using a Respiratory Inductive Plethysmography |
| Change in tidal volume | The outcome will be measured before and at the end of the test, the two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. | Change in tidal volume (Liters) will be measured breath-by-breath using a portable spirometer |
| Change in 6-min walk distance | The outcome will be measured at the end of each tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. | Change in 6-min walk distance (meters). |
| Change in Oxygen Saturation | Data will be continuously collected during every tests. The two six-minute walk test will perform the same day, separate from 30 minutes minimum for a total time frame of 1 day. | Change in Oxygen Saturation (%) using a pulse oximetry |
Countries
France
Outcome results
None listed