No Condition, Healthy FemalesPhase 1NCT02717793
Comparison Between Isotonic 1 Repetition Maximum Measurement With Isometric Muscle Strength Testing In Healthy Females
A Phase 1 study testing Strength testing in people with No Condition, Healthy Females, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
Trial summary
1 repetition maximum (RM) and Maximum Voluntary Contraction (MVC) with digital dynamometer are popular method of measuring muscle strength. The types of muscle contraction involved in both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with digital dynamometer involves isometric muscle… Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- No Condition, Healthy Females
- What is being tested?
- Strength testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalaysia
- Study dates
- Oct 2013to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy females
Who cannot join
- musculoskeletal and neurological disorder
- history of high blood pressure
- heart disease
- rheumatologic disease that affected the mobility
- unstable cardio respiratorydisorder
- cardiovascular disorder
Trial locations and contacts
1 site in 1 country.
About this study
1 repetition maximum (RM) and Maximum Voluntary Contraction (MVC) with digital dynamometer are popular method of measuring muscle strength. The types of muscle contraction involved in both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with digital dynamometer involves isometric muscle contraction (IMMC). There are several risks involved in measurement of 1RM, such as delayed onset muscle soreness (DOMS) and unsafe for pathological joints etc, this can be reduced if IMMC is used in measuring strength. Though both cannot be equated as they are different type of contraction, therefore the purpose of this study was to compare between 1RM measurement and isometric MVC using a digital hand-held dynamometer in healthy females. Twenty nine young females (mean age = 20.77 ± 1.28) without any weight training experience (mean BMI = 20.43 ± 1.85) volunteered for the study. It was a crossover trial where 48 hours of rest period was given between each measurement technique. The result showed moderate correlations (r = 0.365-0.847) between 1RM and MVC. A simple linear regression analysis revealed a significant estimated regression equation for dominant and non-dominant hands. [Dominant, Y=0.391x + 1.472; Non-Dominant, Y=0.251x + 2.629; (Y: 1RM, x: Isometric)] with low standard error of estimation value of (Dominant, 0.74; Non-dominant, 0.80). The result also showed no significant difference between these derived equations and Brzycki 1RM prediction equation. Therefore, it was concluded that both prediction equations can be used interchangeably to predict the strength of a person, and thus IMMC can be used to predict 1RM in healthy females.
Read the detailed description
A dynamic isotonic muscle contraction (ITMC) causes joint movement and excursion of a body segment as the muscle contracts and shortens or lengthens under tension. One repetition maximum (RM) is defined as the maximum weight a person can lift only once in a complete range of motion. It is a gold standard for measuring muscular strength therefore it is used for most of the strength training programmes. The 1RM test has been shown to be reliable in various populations. Further, setting an intensity of resistance training based on a percentage of the 1RM has been found to be effective for improving outcomes such as muscle strength, muscle power, and muscle hypertrophy. Many studies have shown increase in strength when RM testing is repeated over several days to weeks. Therefore, most testing protocols suggest that strength should be measured more than once; typically 2 or 3 testing sessions is recommended.
A familiarisation process prior to 1RM strength testing is necessary to ensure a reliable test result, this minimizes learning effect or systemic bias. It has been shown that without a familiarisation process prior to strength testing, there is a significant increase in the expression of muscle strength. In many studies, investigators have suggested that older individuals need 8-9 sessions of 1RM testing in order to increase the consistency of the 1RM measurements. Therefore, multiple familiarization sessions are beneficial for RM measurements. This draws us to a thought that such sessions may not be practical for studies examining training outcome to record the strength changes for several different resistance exercises as well as numerous other functional parameters. This unnecessarily increases the time requirement and extends the duration of the study, both of which might increase the likelihood of participant dropout in studies and loss of interest in exercise for clients. In the measure of 1RM, especially in patients, using a heavy weight and large number of repetitions imposes a greater risk of injury.
Having been said that, 1RM measurement requires a long period of testing to have a consistent value; it also requires familiarization technique which is also very intense and extensive procedure. To avoid the risk, related to the measurement of 1RM, many studies have been conducted to produce regression equations for predicting 1RM strength. There are other studies too that have been undertaken to determine the accuracy of such equations. Prediction of 1RM strength allows an exercise specialist to assess an individual's maximal lifting capacity without subjecting the novice lifter to the increased risk associated with a 1RM lift. The advantage of calculating 1RM using the formula is that, it provides the therapist with the most widely accepted measure of strength without the risks associated with the formal 1RM testing. However the 1RM load lifting also requires great concentration and considerable mental preparation for the subject which can be an extremely intense experience that leaves them unsure and scared. Although there is no real data concerning the risk of injury in this test, the potential risk may be significantly increased by using very heavy loads.
Testing 1RM uses isotonic movement which may be associated with increased risk of injury as it may include high speed of movement, inability to spread workload evenly over the entire ROM, unsafe for pathological joints, delayed onset of muscle soreness, requirement of equipment which can be expensive, and increased risk of injury, if the movement is done incorrectly. Measuring of 1 RM using the traditional way and by using prediction equation, both involve risk, therefore it brings us to an idea of the use of isometric type of movement in predicting 1RM.
Isometric contraction is a static form of exercise in which a muscle contracts and produces force without an appreciable change in the length of the muscle and without visible joint motion. It is a very popular method of testing the isometric strength of a particular muscle. It is a very easy, fast and accurate method of testing strength of a muscle. Isometric measurement by Lafayette Manual Muscle Test System (model 01163) has been proven to be highly reliable with in inter-class coefficient of 0.85. This method eliminates most of the risk factors that is observed in measuring 1 RM using the traditional way and the prediction equation. Furthermore, it is cost effective, more convenient to be done, and it does not aggravate sensitive joint surfaces. Therefore it reduces most of the risk involved in measuring 1RM using the traditional way and by using prediction equation. However, it is worth mentioning that, isometric strength measurement cannot be replaced with the 1RM measurement which is a dynamic method.
Blazevich et al in their study of reliability and validity of two isometric squat (IS) tests, reported that IS with an isometric rack showed significant and high correlation (r = 0.77) with 1RM squat. However, when Demura, S studied the relationship between 1RM and isometric measurement of squat(IS), their study showed that some component (wide stance and parallel depth) of the squat correlated well with 1 RM whereas others did not. Simple linear regression analysis in their study revealed a relationship of Y = 0.992X + 30.3 (Y: 1RM, X: IS). This suggested that the IS using a back dynamometer may become an effective index for predicting 1RM squat. However, since the standard error of an estimate provided by the regression equation was quite large, (11.19 kg) therefore, it could not estimate 1RM in non-athletes; this study concluded that estimating a 1RM by Isometric squat using a back dynamometer maybe difficult. Though some studies have been conducted to estimate 1RM from isometric strength measurement, there is a dearth in literature to prove the same. Therefore the investigators aim to find out if isometric strength can be compared with 1RM in female subjects without weight training experience. Hence the purpose of this study is to find if there can be comparisons between 1RM (Brzycki's prediction equation) measurement and isometric MVC using a digital hand-held dynamometer in healthy females.
- Conditions
- No Condition, Healthy Females
- Being tested
- Strength testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength testingOther
isometric muscle strength
1RM measurement of muscle strength
| Study group | Role | What they receive |
|---|---|---|
| isometric muscle strength | Experimental | isometric muscle strength was measured with a digital hand-held dynamometer. The digital hand-held dynamometer was held by the therapist against the flexor aspect of the distal forearm of the subject, on the wrist joint. Subject was asked to maintain the position and a break test was done with progressive loading of 5 seconds given by the tester. The peak isometric strength was recorded by a second tester at the end of 5 seconds. A standardised instructions and verbal encouragement was given to the subject for motivation. Subject as well as the tester was blinded to the values recorded on the digital hand-held dynamometer. An average of three measurements (with a rest period of 4 minutes in between each trial session) was recorded for the analysis. After each trial session, the rate of perceived exertion (RPE) was asked to the subject using the "1-10 Borg rating of perceived exertion scale" Receives: Other: Strength testing |
| 1RM measurement of muscle strength | Experimental | 1RM measurement was done using the Brzycki 1RM prediction equation. In first testing session, subject was instructed to perform a general warm up for 5 minutes. Thereafter, the subject was asked to perform 10 repetitions of the movement using the amount of resistance that the subject felt she will be able to lift for only less than 10 times. The selection of the weight is made based on a list of weights provided (1kg to 10kg). When the subject performed the movement for 10 times or more, then the resistance was increased 1kg at a time, until the subject can perform only 9 or fewer repetitions of the movement correctly throughout the range of motion. A 3 minutes rest period was given to the subject before the new attempt was done with the increased weight. A standardized verbal encouragement was provided for motivation Receives: Other: Strength testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Measured: 1 minute after Exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2016 (estimated)
- Study startOct 2013
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Condition, Healthy FemalesStudies 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
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manisha Parai, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02717793
- Sponsor's protocol ID
- SERC231013
- Status last verified
- Mar 2016
- First submitted
- 6 Feb 2016
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Isotonic 1 Repetition Maximum Measurement With Isometric Muscle Strength Testing In Healthy Females
- ClinicalTrials.gov ID
- NCT02717793
- Acronym / sponsor ID
- SERC231013
- Conditions
- No Condition, Healthy Females
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- First posted
- 24 Mar 2016 (estimated)
- 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.
1 repetition maximum (RM) and Maximum Voluntary Contraction (MVC) with digital dynamometer are popular method of measuring muscle strength. The types of muscle contraction involved in both are different, 1RM involves isotonic muscle contraction (ITMC) and MVC with digital dynamometer involves isometric muscle contraction (IMMC). There are several risks involved in measurement of 1RM, such as delayed onset muscle soreness (DOMS) and unsafe for pathological joints etc, this can be reduced if IMMC is used in measuring strength. Though both cannot be equated as they are different type of contraction, therefore the purpose of this study was to compare between 1RM measurement and isometric MVC using a digital hand-held dynamometer in healthy females. Twenty nine young females (mean age = 20.77 ± 1.28) without any weight training experience (mean BMI = 20.43 ± 1.85) volunteered for the study. It was a crossover trial where 48 hours of rest period was given between each measurement technique. The result showed moderate correlations (r = 0.365-0.847) between 1RM and MVC. A simple linear regression analysis revealed a significant estimated regression equation for dominant and non-dominant hands. [Dominant, Y=0.391x + 1.472; Non-Dominant, Y=0.251x + 2.629; (Y: 1RM, x: Isometric)] with low standard error of estimation value of (Dominant, 0.74; Non-dominant, 0.80). The result also showed no significant difference between these derived equations and Brzycki 1RM prediction equation. Therefore, it was concluded that both prediction equations can be used interchangeably to predict the strength of a person, and thus IMMC can be used to predict 1RM in healthy females.
Detailed description
A dynamic isotonic muscle contraction (ITMC) causes joint movement and excursion of a body segment as the muscle contracts and shortens or lengthens under tension. One repetition maximum (RM) is defined as the maximum weight a person can lift only once in a complete range of motion. It is a gold standard for measuring muscular strength therefore it is used for most of the strength training programmes. The 1RM test has been shown to be reliable in various populations. Further, setting an intensity of resistance training based on a percentage of the 1RM has been found to be effective for improving outcomes such as muscle strength, muscle power, and muscle hypertrophy. Many studies have shown increase in strength when RM testing is repeated over several days to weeks. Therefore, most testing protocols suggest that strength should be measured more than once; typically 2 or 3 testing sessions is recommended.
A familiarisation process prior to 1RM strength testing is necessary to ensure a reliable test result, this minimizes learning effect or systemic bias. It has been shown that without a familiarisation process prior to strength testing, there is a significant increase in the expression of muscle strength. In many studies, investigators have suggested that older individuals need 8-9 sessions of 1RM testing in order to increase the consistency of the 1RM measurements. Therefore, multiple familiarization sessions are beneficial for RM measurements. This draws us to a thought that such sessions may not be practical for studies examining training outcome to record the strength changes for several different resistance exercises as well as numerous other functional parameters. This unnecessarily increases the time requirement and extends the duration of the study, both of which might increase the likelihood of participant dropout in studies and loss of interest in exercise for clients. In the measure of 1RM, especially in patients, using a heavy weight and large number of repetitions imposes a greater risk of injury.
Having been said that, 1RM measurement requires a long period of testing to have a consistent value; it also requires familiarization technique which is also very intense and extensive procedure. To avoid the risk, related to the measurement of 1RM, many studies have been conducted to produce regression equations for predicting 1RM strength. There are other studies too that have been undertaken to determine the accuracy of such equations. Prediction of 1RM strength allows an exercise specialist to assess an individual's maximal lifting capacity without subjecting the novice lifter to the increased risk associated with a 1RM lift. The advantage of calculating 1RM using the formula is that, it provides the therapist with the most widely accepted measure of strength without the risks associated with the formal 1RM testing. However the 1RM load lifting also requires great concentration and considerable mental preparation for the subject which can be an extremely intense experience that leaves them unsure and scared. Although there is no real data concerning the risk of injury in this test, the potential risk may be significantly increased by using very heavy loads.
Testing 1RM uses isotonic movement which may be associated with increased risk of injury as it may include high speed of movement, inability to spread workload evenly over the entire ROM, unsafe for pathological joints, delayed onset of muscle soreness, requirement of equipment which can be expensive, and increased risk of injury, if the movement is done incorrectly. Measuring of 1 RM using the traditional way and by using prediction equation, both involve risk, therefore it brings us to an idea of the use of isometric type of movement in predicting 1RM.
Isometric contraction is a static form of exercise in which a muscle contracts and produces force without an appreciable change in the length of the muscle and without visible joint motion. It is a very popular method of testing the isometric strength of a particular muscle. It is a very easy, fast and accurate method of testing strength of a muscle. Isometric measurement by Lafayette Manual Muscle Test System (model 01163) has been proven to be highly reliable with in inter-class coefficient of 0.85. This method eliminates most of the risk factors that is observed in measuring 1 RM using the traditional way and the prediction equation. Furthermore, it is cost effective, more convenient to be done, and it does not aggravate sensitive joint surfaces. Therefore it reduces most of the risk involved in measuring 1RM using the traditional way and by using prediction equation. However, it is worth mentioning that, isometric strength measurement cannot be replaced with the 1RM measurement which is a dynamic method.
Blazevich et al in their study of reliability and validity of two isometric squat (IS) tests, reported that IS with an isometric rack showed significant and high correlation (r = 0.77) with 1RM squat. However, when Demura, S studied the relationship between 1RM and isometric measurement of squat(IS), their study showed that some component (wide stance and parallel depth) of the squat correlated well with 1 RM whereas others did not. Simple linear regression analysis in their study revealed a relationship of Y = 0.992X + 30.3 (Y: 1RM, X: IS). This suggested that the IS using a back dynamometer may become an effective index for predicting 1RM squat. However, since the standard error of an estimate provided by the regression equation was quite large, (11.19 kg) therefore, it could not estimate 1RM in non-athletes; this study concluded that estimating a 1RM by Isometric squat using a back dynamometer maybe difficult. Though some studies have been conducted to estimate 1RM from isometric strength measurement, there is a dearth in literature to prove the same. Therefore the investigators aim to find out if isometric strength can be compared with 1RM in female subjects without weight training experience. Hence the purpose of this study is to find if there can be comparisons between 1RM (Brzycki's prediction equation) measurement and isometric MVC using a digital hand-held dynamometer in healthy females.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isometric muscle strength | Experimental | Other: Strength testingisometric muscle strength was measured with a digital hand-held dynamometer. The digital hand-held dynamometer was held by the therapist against the flexor aspect of the distal forearm of the subject, on the wrist joint. Subject was asked to maintain the position and a break test was done with progressive loading of 5 seconds given by the tester. The peak isometric strength was recorded by a second tester at the end of 5 seconds. A standardised instructions and verbal encouragement was given to the subject for motivation. Subject as well as the tester was blinded to the values recorded on the digital hand-held dynamometer. An average of three measurements (with a rest period of 4 minutes in between each trial session) was recorded for the analysis. After each trial session, the rate of perceived exertion (RPE) was asked to the subject using the "1-10 Borg rating of perceived exertion scale" |
| 1RM measurement of muscle strength | Experimental | Other: Strength testing1RM measurement was done using the Brzycki 1RM prediction equation. In first testing session, subject was instructed to perform a general warm up for 5 minutes. Thereafter, the subject was asked to perform 10 repetitions of the movement using the amount of resistance that the subject felt she will be able to lift for only less than 10 times. The selection of the weight is made based on a list of weights provided (1kg to 10kg). When the subject performed the movement for 10 times or more, then the resistance was increased 1kg at a time, until the subject can perform only 9 or fewer repetitions of the movement correctly throughout the range of motion. A 3 minutes rest period was given to the subject before the new attempt was done with the increased weight. A standardized verbal encouragement was provided for motivation |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy females
Key exclusion criteria (6 listed)
- musculoskeletal and neurological disorder
- history of high blood pressure
- heart disease
- rheumatologic disease that affected the mobility
- unstable cardio respiratorydisorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength testingisometric muscle strength 1RM measurement of muscle strength | Other | 1RM measurement of muscle strength, isometric muscle strength |
Primary outcome
Visual Analogue Scale
Time frame: 1 minute after Exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for No Condition, Healthy Females
Enrolling by invitation
Empowering Postpartum Health Through Exercise
No Condition, Healthy Females
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Strength testing in people with No Condition, Healthy Females, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 28 Mar 2016. 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 Malaysia. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 1 minute after Exercise). 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 28 Mar 2016.