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

NCT06796582 | Not Yet Recruiting

• 1 other identifier: 2025-27-S-CB
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heart Failure; Coronary Heart Disease (CHD); Atrial Fibrillation (AF); Diabetes Mellitus; Arterial Hypertension

Keywords

resistance training; cardiovascular disease; cardiovascular risk factors; muscle strength

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of repetitions required to perform a valid Multiple-Repetition-Maximum test

  cross-sectional (day 1)

• Adverse Events

  cross-sectional (day 1)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

MeSH Terms

Conditions

Heart Failure; Coronary Disease; Atrial Fibrillation; Diabetes Mellitus; Hypertension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Myocardial Ischemia; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Stephan Mueller, Dr rer nat

  Technical University of Munich, Department for Preventive Sports Medicine and Sports Cardiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Mueller, Dr rer nat

CONTACT

+49 (0)89 289 24494; stephan.mueller@mri.tum.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Exercise Physiologist (Postdoctoral Researcher)

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01