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HealthyNCT06648421

Reference Values for the One Repetition Maximum Test of Knee Extensors for Brazilians.

An observational study of Healthy, run by Universidade Estadual de Londrina at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Muscle strength is important for health and can affect how well people live, even increasing the risk of death in adults and older people. The one-repetition maximum (1RM) test is relatively easy compared to other tests and is commonly used to measure muscle strength in various groups, including healthy individuals… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
How many people
72 participants
Where
1 siteBrazil
Study dates
7 Jul 2024to 6 Apr 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Apparently healthy individuals from the local community, as well as students, employees of the involved institution and their families will be recruited, provided they do not have any condition that may limit the performance of the knee extensor muscle strength testing and/or do not have contraindications for its execution.

Who may be able to join

  • Individuals aged between 18-80 years of both sexes;
  • Absence of any condition (e.g., orthopedic, neuromuscular, cardiorespiratory) that may limit the assessment or directly interfere in its results.

Who cannot join

  • Failure to complete the proposed assessments for any reason;
  • A score on the Mini-Mental State Examination lower than18 for illiterate individuals and lower than 24 for literate individuals;
  • Body mass index (BMI) lower than 18 kg/m2 and higher than 40 kg/m2;
  • The manifestation of the desire to leave the study at any time for any reason.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fabio O Pitta, PhD contact

+5543991015480

fabiopitta@uel.br

Brazil1 site, 1 recruiting
  • Health Sciences Center of the State University of Londrina

    Londrina, Paraná, 86038-350

    Fabio O Pitta, PhD, +5543991015480 ext. 2477, fabiopitta@uel.br

    Recruiting

Other trials in Brazil

About this study

Official title: Reference Values for the One Repetition Maximum Test (1RM) of Knee Extensors for Brazilians.

Muscle strength is important for health and can affect how well people live, even increasing the risk of death in adults and older people. The one-repetition maximum (1RM) test is relatively easy compared to other tests and is commonly used to measure muscle strength in various groups, including healthy individuals and those with chronic diseases. It assists in prescribing resistance training and understanding training results. Knee extensors, especially the quadriceps femoris, are often studied because they play a key role in standing and walking. However, there are no standard reference values or equations for measuring knee extensors using the 1RM test. The existing methods rely on the evaluator's judgment, making them hard to replicate and standardize. The goal of this study is to provide reference equations and values for the 1RM of knee extensors and to establish a standardized methodology for the test.

Read the detailed description

The project consists of two phases: in order to develop the final standardized 1RM protocol, a pilot study (phase 1) will be conducted to identify the best objective load to start the 1RM attempts. The protocol will then be defined according to the results of the pilot study, and the main study (phase 2) will be initiated using this protocol.

The one-repetition maximum test (1RM) will be conducted using a leg extension machine (MacSport, Sigma). This test aims to determine the maximum weight that can be lifted in a single movement by the tested muscle group (in this study, knee extensors) through its full range of motion and without compensatory movements. The knees should be aligned with the axis of the equipment (adjust the backrest if necessary), and hands should firmly grip the handles. The equipment will be set so that individuals start the knee extension from a 90 degree flexion and extend until reaching a 0 degree flexion. Standardized verbal encouragement will be given during the tests.

All recruited individuals, both those participating in the pilot study (phase 1) and those in the main study (phase 2), will be evaluated at two different moments. In the first evaluation (pilot study test 1, or pilot study T1), participants will be assessed for anthropometric data, presence of comorbidities, self-reported regular physical activity, cognitive screening and knee extensor muscle strength using the 1RM test, following the protocol proposed by the authors (details below). Specifically for the pilot study, which is a methodological study aimed at identifying the best initial load for the first 1RM attempt, three initial load options based on body weight (40%, 60%, and 80% of body weight) will be randomly assigned via envelopes. The pilot study will include 72 individuals in total, distributed across six age groups with an average interval of ten years (i.e., 18-29, 30-39, 40-49, 50-59, 60-69 and 70-80 years). Each age group will have 12 participants, with four performing the first 1RM attempt at 40% of body weight (two men and two women), another four at 60% of body weight (two men and two women), and the remaining four at 80% of body weight (two men and two women). This way, participants will be evenly distributed among age groups, gender and percentage of body weight for the initial 1RM attempt. In the assessment of the pilot study (pilot study T2), 48-72 hours after the first assessment pilot study T1, individuals will be re-evaluated for knee extensor strength (following the same protocol and the same percentage of body weight as in pilot study T1) to investigate the reproducibility and familiarization (e.g., learning affect) of the test.

The porposed protocol for the pilot study will follow this sequence: (1) warm-up with a set of 10 repetitions with a light load (20% of body weight); (2) two minutes of rest; (3) the frist attempt will be with the percentage of body weight randomly chosen before the start of the pilot (i.e., 40%, 60% or 80% of body weight); (4) the load progression will be based on the Likert scale of difficulty from 1 to 5 (1-Very easy, 2-Easy, 3-Moderate, 4-Very difficult, and 5-Extremely difficult); responses from 1 to 3 will have an increment of 20% of the last load, and responses from 4 to 5 will have an increment of 10% of the last load. Individuals will have two minutes of rest between each progression; (5) if the attempt is unsuccessful, the load should be decreased by 5% or 10%; upon success, this will be the 1RM value, and upon failure, the 1RM will be the last value successfully lifted; (6) the 1RM value should ideally be obtained in 4 to 6 attempts, provided that the last attempt is not the highest value. As mentioned earlier, after 48-72 hours, individuals will perform the pilot study T2 following the same protocol and initial load drawn in pilot study T1. The best initial load for the 1RM test will be the one that allows reaching the highest 1RM value in the fewest attempts in the best tests conducted in pilot study T1 and pilot study T2, as long as they fall within the range of 4 to 6 attempts.

After the completion of the pilot study with the result of the best initial load for the 1RM test, the main study will begin and follow the same protocol previously proposed. However, it will use the best percentage of body weight identified as the ideal initial load in the pilot study during both main study tests (main study T1 and main study T2). In both the pilot and main studies, the same evaluator should perform the test in both T1 and T2, allowing for the analysis of intra-evaluator reproducibility and avoiding potential inter-evaluator bias. The 1RM value used for analysis will be the highest value obtained from the evaluations in main study T1 and main study T2.

The sample size will be calculated based on the pilot study. The variable used for the calculation will be knee extensor strength, as this is the main outcome of the study. A power of 80% and an alpha of 0.05 will be adopted.

Microsoft Excel 2010 (Microsoft, USA) and SPSS 21.0 version (IBM, USA) will be used for data tabulation and statistical analysis, respectively. The Shapiro-Wilk test will be used for the analysis of normality in data distribution. Data with normal distribution will be described as mean ± standard deviation and statistically treated with parametric tests, whereas data with non-normal distribution will be described as median [interquartile range 25-75%] and statistically treated with non-parametric tests. To identify the best initial load for the 1RM test in the pilot study and to compare different age groups, one-way ANOVA or Kruskal-Wallis test with Dunn's post hoc test will be used when necessary. Pearson or Spearman coefficients will be used to identify simple correlations between the 1RM test and anthropometric variables, while multiple linear regression analysis will be used to establish reference equations. A value of P<0.05 will be adopted as statistical significance, except for the multiple linear regression model where variables showing a correlation with 1RM of knee extensors up to P<0.20 will be included in the model.

Conditions
Healthy
Keywords
Muscle Strength, Isotonic Contraction, Reference Values

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06648421
Study groupRoleWhat they receive
Healthy individuals aged 18 to 80 years oldHealthy individuals aged 18 to 80 years old

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle strength of knee extensors

    One repetition maximum test (1RM) of knee extensors

    Measured: 1 week

Secondary outcomes (6)
  1. Weight

    A calibrated digital scale will be used to assess the weight of the individuals in kilograms.

    Measured: 1 week

  2. Height

    Height will be measured in meters using a vertical stadiometer. Weight and height will be combined to report BMI in kg/m^2

    Measured: 1 week

  3. Lower limb measurements

    A measuring tape will be used to measure the length of the tíbia and the thigh circumference, measured 15 cm above the upper edge of the patela.

    Measured: 1 week

  4. Comorbidities

    The presence of comorbidities will be assessed to characterize the sample using the Charslon Comorbidity Index. This index consists of self reported comorbidities that are categorized from 1 to 6 based on the adjusted risk of mortality. The sum of all weights results in a single score for each individual. Higher scores indicate a greater risk, and a score of zero indicates that no comorbidity was reported

    Measured: 1 week

  5. Physical Activity

    Individuals will be asked about their physical activity, type, frequency, duration and how long they have been engaging in this activity using a simple unpublished questionnaire developed by the authors.

    Measured: 1 week

  6. Cognitive Screening

    Cognitive screening will be conducted using the Mini-Mental State Examination (MMSE). This is a simple and easy to administer questionnaire, commmonly used in clinical and research contexts. The MMSE consists of questions grouped into seven categories to assess specific cognitive functions. The score can range from 0 to 30 points. In the Brazilian population, the suggested cutoff point for normal cognitive capacity is 18 points for illiterate individuals and 24 points for literate individuals.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start7 Jul 2024
  3. Primary completion2 Feb 2026 (estimated)
  4. Study completion6 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06648421
Sponsor's protocol ID
6.734.599
Status last verified
Oct 2024
First submitted
15 Oct 2024
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy, run by Universidade Estadual de Londrina at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fabio O Pitta, PhD (+5543991015480, fabiopitta@uel.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle strength of knee extensors (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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Clinical Trial NCT06648421 | AzTrials