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.
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.
Brazil1 site, 1 recruiting
- Recruiting
Health Sciences Center of the State University of Londrina
Londrina, Paraná, 86038-350
Fabio O Pitta, PhD, +5543991015480 ext. 2477, fabiopitta@uel.br
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 group | Role | What they receive |
|---|---|---|
| Healthy individuals aged 18 to 80 years old | Healthy individuals aged 18 to 80 years old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle strength of knee extensors
One repetition maximum test (1RM) of knee extensors
Measured: 1 week
Secondary outcomes (6)
Weight
A calibrated digital scale will be used to assess the weight of the individuals in kilograms.
Measured: 1 week
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
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
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
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
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.
- First posted18 Oct 2024
- Study start7 Jul 2024
- Primary completion2 Feb 2026 (estimated)
- Study completion6 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Londrina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Pitta, PhD, Universidade Estadual de Londrina
- Investigators
- Fabio O Pitta, PhD, Principal investigator, State University of Londrina
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Values for the One Repetition Maximum Test (1RM) of Knee Extensors for Brazilians.
- ClinicalTrials.gov ID
- NCT06648421
- Acronym / sponsor ID
- 6.734.599
- Conditions
- Healthy
- Keywords
- Muscle Strength, Isotonic Contraction, Reference Values
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Universidade Estadual de LondrinaUniversity, hospital or other
- Study start
- 7 Jul 2024 (actual)
- Primary completion
- 2 Feb 2026 (estimated)
- Study completion
- 6 Apr 2026 (estimated)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals aged 18 to 80 years old | – | –Healthy individuals aged 18 to 80 years old |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Muscle strength of knee extensors
Time frame: 1 week
One repetition maximum test (1RM) of knee extensors
6 secondary outcomes
Weight
Time frame: 1 week
Height
Time frame: 1 week
Lower limb measurements
Time frame: 1 week
Comorbidities
Time frame: 1 week
Physical Activity
Time frame: 1 week
Cognitive Screening
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fabio O Pitta, PhD principal investigator
State University of Londrina
1 site in 1 country: see every site and its status.
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.