Does blocking the body's own morphine-like chemicals during exercise change the perception of breathlessness?
- Conditions
- Breathlessness during exercise in people with Chronic Obstructive Pulmonary Disease.Respiratory - Chronic obstructive pulmonary disease
- Registration Number
- ACTRN12611001182987
- Lead Sponsor
- Flinders University- Deptment of Palliative and Supportive Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
On stable medications for breathlessness over the prior one week except routine as needed” medications. Able to provide written and dated informed consent.Moderate / severe COPD. (FEV1 30%-80% of predicted for age in spirometry performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI) with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated using NHANES III reference equations) [Hankinson 1999]. Subjects will have COPD which complies with the definition of the American Thoracic. Society/European Respiratory Society. [Celli, 2004). Modified Medical Research Council breathlessness scale of 3 or 4. >50 years of age. >10 pack year history of smoking (number of pack years = (number of cigarettes per day/20) x number of years smoked). Able to use a treadmill.
On regular or ‘as needed’ opioids in the week before commencing the study and at any time during the study.
Unable to give informed consent or complete evaluation tool entries. Cognitively impaired (Mini Mental State < 24). [Folstein]. Calculated creatinine clearance of < 30mls using MDRD. [Levey 1999] . Known or suspected bowel obstruction (specific contra-indications in methylnaltrexone) or known or suspected GI lesions.
Participants with any of the following clinical conditions:
a history of myocardial infarction, unstable angina or untreated severe left anterior descending coronary artery compromise within 1 year of screening visit, cardiac arrhythmia causing symptoms or haemodynamic compromise, atrioventricular block, hospitalized for heart failure within the past year, claudication, known active tuberculosis or other chronic lung infection, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis.
Contraindications for exercise testing which would include
active endocarditis, myocarditis or pericarditis, hypertrophic cardiomyopathy, symptomatic moderate to severe aortic stenosis, severe untreated arterial hypertension (>160 mmHg systolic, >110 mmHg diastolic), significant pulmonary hypertension, untreated venous thromboembolism, active systemic infection, uncontrolled hyperthyroidism, body mass index (BMI) >35, physical limitations due to arthritis, joint replacement, people on monoamine oxidase inhibitors. Participants who are currently under going pulmonary rehabilitation or have completed a pulmonary rehabilitation program in the previous six weeks. Participants with an endurance time > 25 minutes during the training (visit 2)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method