Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06648421
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-15
Brief Title:
Reference Values for the One Repetition Maximum Test of Knee Extensors for Brazilians
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Reference Values for the One Repetition Maximum Test 1RM of Knee Extensors for Brazilians
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 evaluators 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 ie 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 eg 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 ie 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 005 will be adopted
Microsoft Excel 2010 Microsoft USA and SPSS 210 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 Dunns 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 P005 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 P020 will be included in the model
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 ie 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 eg 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 ie 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 005 will be adopted
Microsoft Excel 2010 Microsoft USA and SPSS 210 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 Dunns 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 P005 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 P020 will be included in the model
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None