The COmPLETE Study
- Conditions
- AgingHeart Failure
- Interventions
- Behavioral: Physical Activity
- Registration Number
- NCT03986892
- Lead Sponsor
- Arno Schmidt-Trucksäss
- Brief Summary
The project is designed as a large scale, cross-sectional study. This research seeks to identify physical fitness and cardiovascular parameters that best resemble underlying cardiovascular risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure.
- Detailed Description
Cardiovascular (CV) diseases including heart failure are the leading causes of morbidity, with age being the primary risk factor. The combination of age-related organic functional impairment and reduced physical fitness can drastically impact an individual's healthspan. One's lifespan can potentially be prolonged by the preservation or improvement of physical fitness. However, it remains unclear as to which biomarkers are most suitable for distinguishing between healthy aging and the impaired organ function associated with heart failure. Therefore, a comprehensive assessment of the components of physical fitness and CV function will be performed to identify the most important factors contributing to aging in relation to both health and disease.
This cross-sectional investigation will consist of two parts: the COmPLETE-Health (C-Health) and COmPLETE-Heart (C-Heart) studies. C-Health will examine the aging trajectories of physical fitness components and CV properties in a healthy population sample aged between 20 and 100 years (n = 490). Separately, C-Heart will assess the same markers in patients at different stages of chronic heart failure (n = 80). The primary outcome to determine the difference between C-Health and C-Heart will be cardiorespiratory fitness as measured by cardiopulmonary exercise testing on a bicycle ergometer. Secondary outcomes will include walking speed, balance, isometric strength, peak power, and handgrip strength. Physical activity as a behavioural component will be assessed objectively via accelerometry. Further, CV assessments will include pulse wave velocity; retinal, arterial, and venous diameters; brachial and retinal arterial endothelial function; carotid intima-media thickness; and systolic and diastolic function. The health distances for C-Health and C-Heart will be calculated using the methodology based on statistical (Mahalanobis) distance applied to measurements of quantitative biomarkers.
This research seeks to identify physical fitness and CV biomarkers that best resemble underlying CV risk with age. Further, it will examine which physical fitness markers are impaired most in heart failure. The presented integrative approach could define new recommendations for diagnostic guidance in aging. Ultimately, this study is expected to offer a better understanding of which functional characteristics should be specifically targeted in primary and secondary prevention to achieve an optimal healthspan.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 678
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COmPLETE-Health Physical Activity No intervention COmPLETE-Heart Physical Activity No intervention
- Primary Outcome Measures
Name Time Method Cardiorespiratroy Fitness 3 hours after inclusion in study Maximal Oxygen uptake measured by cardiopulmonary exercise testing (VO2peak) in L/min
Ventilatory Efficiency 3 hours after inclusion in study VE/VCO2 measured by cardiopulmonary exercise testing ((L/min)/(L/min))
Arterial stiffness 0.5 hours after inclusion in study Meausred by an noninvasive vascular screening system. Reported as brachial-ankle pulse wave velocity (baPWV).
Endothelial function 1 hours after inclusion in study Meausred as flow mediated dilation (FMD) by ultrasound reported as %.
Carotid-intima-media thickness 1 hour after inclusion in study Carotid intima-media thickness (mm) is measured by 2D ultrasound instrument.
Oxygen Uptake Efficiency 3 hours after inclusion in study The Oxygen Uptake Efficiency Slope is defined as the regression slope 'a' in V̇O2 = a × log VE +b measured by cardiopulmonary exercise testing.
Gait speed 1.5 hours after inclusion in study Gait speed measured by an inertial sensor system in m/s.
Hand grip strength 2.5 hours after inclusion in study Measured by a handheld dynamometer. Maximal achieved grip strength (kg) is recorded.
Standing balance 2.5 hours after inclusion in study The cumulative sway path (cm) serves as a measure of postural control.
Retinal arterial and venous diameters 7-30 days after inclusion in study Measured by static retinal vessel analysis. Diameters will be averaged to central retinal arteriolar and venular equivalents (CRAE and CRVE) and the arteriolar-to-venular diameter ratio will be calculated from the CRAE and CRVE.
Power of leg muscles 2.5 hours after inclusion in study Peak power measured by countermovement jump performed on a force plate. Reported in N/kg
Left ventricular ejection fraction 1 hour after inclusion in study Meausred by echocardiography reported as %.
Retinal endothelial function 7-30 days after inclusion in study Measured by dynamic retinal vessel analysis reported as %.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel
🇨🇭Basel, Switzerland