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

January 27, 2025 updated by: Stephan Mueller, Technical University of Munich

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
cross-sectional study (day 1)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
cross-sectional (day 1)
Adverse Events
Time Frame: cross-sectional (day 1)
any adverse events that occur in relation to the Multiple-Repetition-Maximum Tests will be documented
cross-sectional (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephan Mueller, Dr rer nat, Technical University of Munich, Department for Preventive Sports Medicine and Sports Cardiology

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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