Clinical trial NCT06796582: Reliability of Multiple-Repetition-Maximum Tests in Patients with Cardiovascular Disease or Risk Factors
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Coronary Heart Disease (CHD)
Atrial Fibrillation (AF)
Diabetes Mellitus
Arterial Hypertension
Keywords: resistance training
cardiovascular disease
cardiovascular risk factors
muscle strength
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visit the outpatient clinic for Preventive Sports Medicine and Sports Cardiology at the TUM University Hospital, Munich, Germany

Brief 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. 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).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* At least one of the following cardiovascular diseases / risk factors:
* Heart failure
* Coronary heart disease
* Atrial fibrillation
* Arterial hypertension
* Type 2 diabetes mellitus
* Clinically stable for ≥ 4 weeks
* Medical clearance to perform resistance training / strength testing
* Signed written informed consent

Exclusion Criteria:

* 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

Primary outcomes:
measure: Estimated 1-Repetition-Maximum
timeFrame: cross-sectional study (day 1)
Secondary outcomes:
measure: Number of repetitions required to perform a valid Multiple-Repetition-Maximum test
timeFrame: cross-sectional (day 1)
measure: Adverse Events
timeFrame: cross-sectional (day 1)
Other outcomes:
Locations:
Study officials:
affiliation: Technical University of Munich, Department for Preventive Sports Medicine and Sports Cardiology
name: Stephan Mueller, Dr rer nat
role: PRINCIPAL_INVESTIGATOR
References: