NCT03058081CompletedNot Applicable
Acute Effects of High Flow Nasal Support During Exercise in Patients With COPD After Severe Exacerbation
Groupe Hospitalier du Havre2 sites in 1 country19 target enrollmentStarted: August 1, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Groupe Hospitalier du Havre
- Enrollment
- 19
- Locations
- 2
- Primary Endpoint
- Difference in exercise capacity
Study Overview
Brief Summary
Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. High flow ventilation in reducing work of breathing and dyspnea may improve exercise tolerance. The aim of this study is to carry out the acute effect of high flow nasal cannula on exercise endurance in post-exacerbation copd patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •a diagnosis of COPD
Exclusion Criteria
- •exercise contraindication Any musculoskeletal problems, cardiovascular or neurological comorbidities that limits exercise.
- •pH < 7,35
- •Body temperature > 38°C
- •cardiac frequency > 100 bpm at rest
- •systolic blood pressure < 100 mmHg
- •exacerbation during the study
Outcomes
Primary Outcomes
Difference in exercise capacity
Time Frame: The outcome will be measure after every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum
Difference in endurance time (TLim) during High Intensity Constant Work-Rate Endurence Test (CWRET)
Secondary Outcomes
- Difference in peripheral muscle oxygenation(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise)
- Difference in Cardiac Frequency(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise)
- Difference in Dyspnea and muscular fatigue(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be collected every 2 minute during tests and at the end of the exercise)
- Difference in Respiratory Muscle Fatigue(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be collected before and 5 minute maximum after exercise)
- Difference in Oxygen Saturation(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise)
- Difference in Transcutaneous Carbon Dioxide(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise)
- Difference in Respiratory Rate(The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 3 days maximum. Data will be continuously collected during exercise)
Investigators
Study Sites (2)
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