A prospective clinical trial to evaluate the validity of smartwatches compared to standard ECG in obese participants during treadmill exercises. THE PREPARE BASKET TRIAL TASK I

A prospective clinical trial to evaluate the validity of smartwatches compared to standard ECG in obese participants during treadmill exercises. THE PREPARE BASKET TRIAL TASK I - PREPARE BASKET TRIAL TASK I

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00040043

Enrollment

Registered

2026-06-12

Start date

2026-08-03

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, BMI>30

Interventions

Group 1: Obese participants with a BMI > 30 Participants will undergo conventional heart rate monitoring via ECG and will be equipped with a smartwatch, either an Apple Watch or a Samsung Watch (Andro

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Written informed consent - Willingness to participate - BMI = 30 - Ownership of a smartphone

Exclusion criteria

Exclusion criteria: - under 18 years of age - BMI 3 - Participants who are unable to walk, run, or climb stairs - Participants with acute (or chronic) cardiovascular disease: o Acute myocardial infarction or unstable angina pectoris (acute phase) (I20.0, I21) o Uncontrolled arrhythmias with symptoms or hemodynamic impairment o Acute myocarditis or pericarditis (I30, I39, I40) o Suspected aneurysmal dissection - Uncontrolled, acutely decompensated heart failure (acute pulmonary edema) (J81) - Heart rate > 120 bpm, systolic blood pressure > 180 mmHg or diastolic > 120 mmHg - Acute pulmonary embolism (I26) - Shortness of breath at rest (respiratory rate > 25/min) - Exertional dyspnea after climbing fewer than two flights of stairs - Chest pain at rest - Severe hypoxemia at rest or acute respiratory failure (J80) - Acute non-cardiopulmonary disease that impairs physical capacity or may worsen with exercise (e.g., infection, renal failure, thyrotoxicosis) - Mental impairment with inability to cooperate - Participants under legal guardianship or incarcerated

Design outcomes

Primary

Measure	Time frame
Evaluation of the safety and accuracy of smartwatches (Apple and Android models) compared to standard ECG measurements taken simultaneously in obese participants (BMI =30) on a treadmill during various endurance exercises. The smartwatches record data on heart rate, distance walked, and walking speed. The data is collected during endurance training. Primary endpoint: Completion of a full interval training session with ECG and smartwatch measurements following a 6-minute walk test, with heart rate variability at the measurement points <10 bpm	—

Measure

Time frame

Evaluation of the safety and accuracy of smartwatches (Apple and Android models) compared to standard ECG measurements taken simultaneously in obese participants (BMI =30) on a treadmill during various endurance exercises. The smartwatches record data on heart rate, distance walked, and walking speed. The data is collected during endurance training. Primary endpoint: Completion of a full interval training session with ECG and smartwatch measurements following a 6-minute walk test, with heart rate variability at the measurement points <10 bpm

—

Secondary

Measure	Time frame
Secondary endpoints: reports of adverse events or serious adverse events, withdrawal of consent.	—

Countries

Germany

Contacts

Public ContactSvenja Sliwinski

Universitätsmedizin Frankfurt

svenja.sliwinski@ukffm.de+49696301172248

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 10, 2026