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Clinical Trials/NCT06796582
NCT06796582Not yet recruitingNot Applicable

Agreement of the Estimated 1-Repetition-Maximum Between Two Multiple-Repetition-Maximum Tests with Different Weight in Patients with Cardiovascular Disease or Risk Factors

Technical University of Munich0 sites50 target enrollmentStarted: February 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
50
Primary Endpoint
Estimated 1-Repetition-Maximum

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Number of repetitions required to perform a valid Multiple-Repetition-Maximum test(cross-sectional (day 1))
  • Adverse Events(cross-sectional (day 1))

Investigators

Sponsor
Technical University of Munich
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stephan Mueller

Exercise Physiologist (Postdoctoral Researcher)

Technical University of Munich

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