We are investigating the effect of mechanical bowel preparation, such as Picolax, on aerobic exercise capacity in healthy volunteers.
Conditions
Interventions
Trade Name: Picolax
Product Name: Picolax
Pharmaceutical Form: Powder for oral solution
Sponsors
Plymouth Hospitals NHS Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Does mechanical bowel preparation and fasting influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test? 2. Does a carbohydrate-loading drink influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test? ;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? 2. Does a carbohydrate-loading drink influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test? | — |
Countries
United Kingdom
Outcome results
None listed