The COmPLETE Study

NCT03986892 | Completed

• 1 other identifier: 182815
• Study Type: observational
• Target: 678
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Heart Failure

Keywords

fitness; exercise; vascular function

Outcome Measures

Primary Outcomes (13)

• Cardiorespiratroy Fitness

  Maximal Oxygen uptake measured by cardiopulmonary exercise testing (VO2peak) in L/min

  3 hours after inclusion in study

• Ventilatory Efficiency

  VE/VCO2 measured by cardiopulmonary exercise testing ((L/min)/(L/min))

  3 hours after inclusion in study

• Oxygen Uptake Efficiency

  The Oxygen Uptake Efficiency Slope is defined as the regression slope 'a' in V̇O2 = a × log VE +b measured by cardiopulmonary exercise testing.

  3 hours after inclusion in study

• Gait speed

  Gait speed measured by an inertial sensor system in m/s.

  1.5 hours after inclusion in study

• Standing balance

  The cumulative sway path (cm) serves as a measure of postural control.

  2.5 hours after inclusion in study

• Hand grip strength

  Measured by a handheld dynamometer. Maximal achieved grip strength (kg) is recorded.

  2.5 hours after inclusion in study

• Power of leg muscles

  Peak power measured by countermovement jump performed on a force plate. Reported in N/kg

  2.5 hours after inclusion in study

• Arterial stiffness

  Meausred by an noninvasive vascular screening system. Reported as brachial-ankle pulse wave velocity (baPWV).

  0.5 hours after inclusion in study

• Endothelial function

  Meausred as flow mediated dilation (FMD) by ultrasound reported as %.

  1 hours after inclusion in study

• Left ventricular ejection fraction

  Meausred by echocardiography reported as %.

  1 hour after inclusion in study

• Carotid-intima-media thickness

  Carotid intima-media thickness (mm) is measured by 2D ultrasound instrument.

  1 hour after inclusion in study

• Retinal arterial and venous diameters

  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.

  7-30 days after inclusion in study

• Retinal endothelial function

  Measured by dynamic retinal vessel analysis reported as %.

  7-30 days after inclusion in study

Study Arms (2)

COmPLETE-Health

No intervention

Behavioral: Physical Activity

COmPLETE-Heart

No intervention

Behavioral: Physical Activity

Interventions

Physical Activity BEHAVIORAL

Physical Activity

COmPLETE-Health; COmPLETE-Heart

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In C-Health, recruitment will be performed until a total number of 490 participants with a valid cardiopulmonary exercise test (CPET) as our primary outcome are included. All participants will be recruited in the area of Basel, including 35 males and 35 females per age category (i.e., 20-29, 30-39, 40-49, 50-59, 60-69, 70-79, and 80+ years of age). C-Heart will include 80 heart failure patients characterized according to criteria named below. Stable CHF (treated patient with symptoms and signs that have remained generally unchanged for at least one month) characterized according to the European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure \[82\], as follows: 1. HFrEF (LVEF \< 40%) 2. HFmHF (LVEF 40-49%) 3. HFpEF (LVEF ≥ 50%) and NT-proBNP \> 125 pg/mL and structural or functional changes in echocardiography in no. 2 or 3.

You may qualify if:

• C-Health:
• Healthy men and women aged 20-100 years
• Body mass index \< 30 kg/m2
• Nonsmoker
• C-Heart:
• Stable CHF (treated patient with symptoms and signs that have remained generally unchanged for at least one month) characterized according to the European Society of Cardiology guidelines for the diagnosis and treatment of acute and chronic heart failure \[82\], as follows:
• HFrEF (LVEF \< 40%)
• HFmHF (LVEF 40-49%)
• HFpEF (LVEF ≥ 50%) and NT-proBNP \> 125 pg/mL and structural or functional changes in echocardiography in no. 2 or 3.

You may not qualify if:

• C-Health:
• Age younger than 20 years; manifest exercise limiting chronic disease (e.g., myocardial infarction; stroke; heart failure; lower-extremity artery disease; cancer with general symptoms; diabetes; clinically apparent renal failure; severe liver disease; chronic bronchitis GOLD stages II to IV; osteoporosis), women with known pregnancy or breastfeeding; drug or alcohol abuse; hypertonic blood pressure of less than 160/100 mmHg; compromising orthopaedic problems; Alzheimer's disease or any other form of dementia; inability to follow the procedures of the study (e.g., due to language problems, psychological disorders, dementia of the participant); diseases regarded as an absolute contraindication for maximal exertion; and current or past smoking status.
• C-Heart:
• Age younger than 20 years; women with known pregnancy or breastfeeding; drug or alcohol abuse; inability to follow the study procedures (e.g., due to language problems, psychological disorders, etc.); unstable angina pectoris; uncontrolled brady- or tachyarrythmia; paroxysmal atrial fibrillation; severe uncorrected valvular disease; acute myocardial infarction or coronary syndrome; transient ischemic attack or stroke occurring less than three months prior; clinically significant concomitant disease states (e.g. uncontrolled hypertonic blood pressure); clinical evidence of current malignancy with exception of basal cell or squamous cell carcinoma of the skin and/or cervical intraepithelial neoplasia; currently receiving systemic chemotherapy and/or radiotherapy; significant musculoskeletal disease other than that associated with heart failure limiting exercise tolerance; active infection; immunosuppressive medical therapy; life-expectancy of less than six months; and prevalence of a disease regarded as an absolute contraindication for maximal exertion.

Sponsors & Collaborators

• Arno Schmidt-Trucksäss: lead

Study Sites (1)

Department for Sport, Exercise and Health, Section Sports and Exercise Medicine, University of Basel

Basel, 4052, Switzerland

Location

Related Publications (5)

• Schwendinger F, Knaier R, Wagner J, Infanger D, Lichtenstein E, Hinrichs T, Rowlands A, Schmidt-Trucksass A. Relative and absolute intensity accelerometer metrics decipher the effects of age, sex, and occupation on physical activity. BMC Public Health. 2025 Mar 6;25(1):885. doi: 10.1186/s12889-025-21800-w.

  PMID: 40050804 DERIVED

• Prechtl L, Carrard J, Gallart-Ayala H, Borreggine R, Teav T, Konigstein K, Wagner J, Knaier R, Infanger D, Streese L, Hinrichs T, Hanssen H, Ivanisevic J, Schmidt-Trucksass A. Circulating amino acid signature features urea cycle alterations associated with coronary artery disease. Sci Rep. 2024 Oct 28;14(1):25848. doi: 10.1038/s41598-024-76835-7.

  PMID: 39468229 DERIVED

• Schwendinger F, Wagner J, Knaier R, Infanger D, Rowlands AV, Hinrichs T, Schmidt-Trucksass A. Accelerometer Metrics: Healthy Adult Reference Values, Associations with Cardiorespiratory Fitness, and Clinical Implications. Med Sci Sports Exerc. 2024 Feb 1;56(2):170-180. doi: 10.1249/MSS.0000000000003299. Epub 2023 Sep 12.

  PMID: 37703330 DERIVED

• Schwendinger F, Wagner J, Infanger D, Schmidt-Trucksass A, Knaier R. Methodological aspects for accelerometer-based assessment of physical activity in heart failure and health. BMC Med Res Methodol. 2021 Nov 14;21(1):251. doi: 10.1186/s12874-021-01350-6.

  PMID: 34775952 DERIVED

• Streese L, Vaes A, Infanger D, Roth R, Hanssen H. Quantification of Retinal Vessel Myogenic Constriction in Response to Blood Pressure Peaks: Implications for Flicker Light-Induced Dilatation. Front Physiol. 2021 Feb 18;12:608985. doi: 10.3389/fphys.2021.608985. eCollection 2021.

  PMID: 33679432 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 14, 2019
• Study Start: January 3, 2018
• Primary Completion: December 20, 2019
• Study Completion: January 31, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)