A Study into the Effect of Mechanical Bowel Preparation on Aerobic Exercise Capacity as Measured by Cardiopulmonary Exercise Testing. - PicoPEX: Picolax and Pre-Operative Cardio-Pulmonary Exercise Testing
- Conditions
- We are investigating the effect of mechanical bowel preparation, such as Picolax, on aerobic exercise capacity in healthy volunteers.
- Registration Number
- EUCTR2009-016874-34-GB
- Lead Sponsor
- Plymouth Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
Inclusion Criteria:
Healthy Male Volunteers (ASA I)
Willingness to Participate
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Male volunteers deemed ASA II or greater
Absolute
Acute myocardial infarction (3–5 days)
Unstable angina
Uncontrolled arrhythmias causing symptoms or haemodynamic compromise
Syncope
Active endocarditis
Acute myocarditis or pericarditis
Symptomatic severe aortic stenosis
Uncontrolled heart failure
Acute pulmonary embolus or pulmonary infarction
Thrombosis of lower extremities
Suspected dissecting aneurysm
Uncontrolled asthma
Pulmonary oedema
Room air desaturation at rest < 85%*
Respiratory failure
Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
Previous reaction to mechanical bowel preparation
Relative
Left main coronary stenosis or its equivalent
Moderate stenotic valvular heart disease
Severe untreated arterial hypertension (200 mm Hg systolic, 120 mm Hg diastolic)
Tachyarrhythmias or bradyarrhythmias
High-degree atrioventricular block
Hypertrophic cardiomyopathy
Significant pulmonary hypertension
Advanced or complicated pregnancy
Electrolyte abnormalities
Orthopaedic impairment that compromises exercise performance
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. Does mechanical bowel preparation and fasting influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test?<br>2. Does a carbohydrate-loading drink influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test?<br>;Secondary Objective: None;Primary end point(s): 1. Does mechanical bowel preparation and fasting influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test?<br>2. Does a carbohydrate-loading drink influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test?<br>
- Secondary Outcome Measures
Name Time Method