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NCT Number: NCT06796582

Reliability of Multiple-Repetition-Maximum Tests 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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: cross-sectional (day 1)

    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.

  2. Adverse Events

    Time frame: cross-sectional (day 1)

    any adverse events that occur in relation to the Multiple-Repetition-Maximum Tests will be documented

Study contacts

Contact information is provided by the study sponsor or research team.

Stephan Mueller, Dr rer nat

CONTACT

[email protected]

+49 (0)89 289 24494

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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