Heart FailureNCT06796582
Reliability of Multiple-Repetition-Maximum Tests in Patients With Cardiovascular Disease or Risk Factors
An observational study of Heart Failure and Coronary Heart Disease (CHD), run by Technical University of Munich at 1 site in Germany.
Trial summary
Exercise training is a cornerstone in the prevention and rehabilitation of cardiovascular disease. While research has primarily focused on endurance training, resistance training becomes more and more important. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Heart Failure, Coronary Heart Disease (CHD), Atrial Fibrillation (AF)
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2025to Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who visit the outpatient clinic for Preventive Sports Medicine and Sports Cardiology at the TUM University Hospital, Munich, Germany
Who may be able to join
- Age ≥ 50 years
- At least one of the following cardiovascular diseases / risk factors:
- Heart failure
- Coronary heart disease
- Atrial fibrillation
- Arterial hypertension
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- Type 2 diabetes mellitus
- Clinically stable for ≥ 4 weeks
- Medical clearance to perform resistance training / strength testing
- Signed written informed consent
Who cannot join
- Pregnancy
- Acute infection
- Chronic joint inflammation
- Knee, hip, ankle, wrist, elbow or shoulder pain
- Known osteoporosis (T-value ≤ -2.5)
- Uncontrolled hypertension (≥160 mmHG systolic / ≥100 mmHG diastolic)
- Known cerebral or thoracic aneurysm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department for Preventive Sports Medicine and Sports Cardiology, TUM Klinikum Rechts der Isar, Technical University of Munich
München, 80809
Stephan Mueller, Dr. rer. nat., +49 (0)89 289 24494, stephan.mueller@mri.tum.de
About this study
Official title: Agreement of the Estimated 1-Repetition-Maximum Between Two Multiple-Repetition-Maximum Tests With Different Weight in Patients With Cardiovascular Disease or Risk Factors
Exercise training is a cornerstone in the prevention and rehabilitation of cardiovascular disease. While research has primarily focused on endurance training, resistance training becomes more and more important. The gold standard to prescribe resistance training intensity or monitor longitudinal changes is the 1-Repetition-Maximum (1-RM) test. However, particularly for unexperienced individuals, this test may not be recommendable due to the high load and an increased risk of injuries. Alternatively, there are several published formulas to estimate the 1-RM based on a multiple-repetition-maximum (or repetition-to-failure) test. However, these formulas have been primarily tested in healthy individuals. Moreover, the reliability of the 1-RM estimation based on two tests with different submaximal weight is unknown. Therefore, the present study evaluates the agreement of the 1-RM estimation (based on different formulas) between two Multiple-RM tests with different weight in 50 patients with cardiovascular disease (heart failure, coronary heart disease, atrial fibrillation) or cardiovascular risk factors (type 2 diabetes, arterial hypertension).
- Conditions
- Heart Failure, Coronary Heart Disease (CHD), Atrial Fibrillation (AF), Diabetes Mellitus, Arterial Hypertension
- Keywords
- resistance training, cardiovascular disease, cardiovascular risk factors, muscle strength
- Medical subject headings
- Heart Failure, Coronary Disease, Atrial Fibrillation, Diabetes Mellitus, Hypertension, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated 1-Repetition-Maximum
The estimated 1-Repetition-Maximums based on two Multiple-Repetition-Maximum tests with different weight will be compared using Bland-Altman plots. Acceptable Limits of Agreement are defined as +/- 10%. The comparisons will be performed using different published formulas to evaluate, which formula(s) may be recommended in patients with cardiovascular disease / risk factors. The study will be performed on the following resistance training machines: leg press and chest press
Measured: cross-sectional study (day 1)
Secondary outcomes (2)
Number of repetitions required to perform a valid Multiple-Repetition-Maximum test
The Multiple-Repetition-Maximum test is considered valid if muscular failure occurs after completion of 2-10 repetitions. This is based on the evidence that (most) published formulas become less precise if >10 repetitions can be performed.
Measured: cross-sectional (day 1)
Adverse Events
any adverse events that occur in relation to the Multiple-Repetition-Maximum Tests will be documented
Measured: cross-sectional (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start14 Jul 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan Mueller, Technical University of Munich
- Investigators
- Stephan Mueller, Dr rer nat, Principal investigator, Technical University of Munich, Department for Preventive Sports Medicine and Sports Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796582
- Sponsor's protocol ID
- 2025-27-S-CB
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will depend on the possibility to anonymize the requested data set and must be approved by the data security department of the TUM University Hospital