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
- Are there results?
- Not yet: the study is under way
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
Show all 10Show fewer
- 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.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06796582
- Acronym / sponsor ID
- 2025-27-S-CB
- Conditions
- Heart Failure, Coronary Heart Disease (CHD), Atrial Fibrillation (AF), Diabetes Mellitus, Arterial Hypertension
- Keywords
- resistance training, cardiovascular disease, cardiovascular risk factors, muscle strength
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (10 listed)
- Age ≥ 50 years
- At least one of the following cardiovascular diseases / risk factors:
- Heart failure
- Coronary heart disease
- Atrial fibrillation
Key exclusion criteria (7 listed)
- Pregnancy
- Acute infection
- Chronic joint inflammation
- Knee, hip, ankle, wrist, elbow or shoulder pain
- Known osteoporosis (T-value ≤ -2.5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Estimated 1-Repetition-Maximum
Time frame: cross-sectional study (day 1)
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
2 secondary outcomes
Number of repetitions required to perform a valid Multiple-Repetition-Maximum test
Time frame: cross-sectional (day 1)
Adverse Events
Time frame: cross-sectional (day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephan Mueller, Dr rer nat principal investigator
Technical University of Munich, Department for Preventive Sports Medicine and Sports Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Coronary Heart Disease (CHD), run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan Mueller, Dr rer nat (+49 (0)89 289 24494, stephan.mueller@mri.tum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated 1-Repetition-Maximum (time frame: cross-sectional study (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.