Reliability of Multiple-Repetition-Maximum Tests in Patients with Cardiovascular Disease or Risk Factors

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Diabetes Mellitus; Arterial Hypertension; Atrial Fibrillation (AF); Coronary Heart Disease (CHD)

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Stephan Mueller, Dr rer nat; Phone Number: +49 (0)89 289 24494; Email: stephan.mueller@mri.tum.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	cross-sectional study (day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	cross-sectional (day 1)
Adverse Events	any adverse events that occur in relation to the Multiple-Repetition-Maximum Tests will be documented	cross-sectional (day 1)

Collaborators and Investigators

• Sponsor: Technical University of Munich
• Investigators: Principal Investigator: Stephan Mueller, Dr rer nat, Technical University of Munich, Department for Preventive Sports Medicine and Sports Cardiology

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 22, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: muscle strength; cardiovascular disease; cardiovascular risk factors; resistance training
• Additional Relevant MeSH Terms: Vascular Diseases; Pathologic Processes; Arrhythmias, Cardiac; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Heart Diseases; Atrial Fibrillation; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: 2025-27-S-CB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No