Effects of Menthol on Dyspnoea in COPD Patients
- Conditions
- CopdLung DiseasesDyspnea
- Interventions
- Other: Test with MentholOther: Test with placebo
- Registration Number
- NCT03626519
- Lead Sponsor
- Groupe Hospitalier du Havre
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
- a diagnosis of COPD
- Dyspnea in daily living (2-4 on the modified medical research council dyspnea scale)
- Clinically stable
- exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
- exacerbation during the study
- Inability to chew or patients with swallowing disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test with Menthol Test with Menthol Patients will chew a menthol flavored chewing gum 5 minutes before perform one Six-minute Walk Test Test with placebo Test with placebo Patients will chew a strawberry flavored chewing gum 5 minutes before perform one Six-minute Walk Test
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
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 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).
Trial Locations
- Locations (3)
Centre hospitalier des Pays de Morlaix
🇫🇷Morlaix, Bretagne, France
Groupe Hospitalier du Havre
🇫🇷Le Havre, Normandie, France
Resp'Air
🇫🇷Talence, Nouvelle-Aquitaine, France