FatigueNCT03923608
Reliability of a Endurance and a Strength Test for Shoulder Rotation
An observational study of Fatigue, run by São Paulo State University at 1 site in Brazil.
Trial summary
Introduction: Verification of the progression of individuals submitted to training programs is performed by diagnostic tests with a focus on strength and muscular endurance. Among the tools used are the elastic bands, the halter, the pulley, the digital dynamometer and, additionally, the isokinetic dynamometer… Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Maximal muscle strength Test and Exhaustion test
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2019to 30 Jul 2019
- Phase
- Observational
- 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 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The sample is composed of apparently healthy young men, of both genders, between 13 and 30 years old.
Who may be able to join
- anemia,
- diabetes,
- cardiovascular disease,
- and upper limb and spinal muscular injuries in the last six months
Who cannot join
- absence at any study session and
- episode of muscle-tendon or osteoarticular injury in the upper limbs during the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
State University of são Paulo
Presidente Prudente, São Paulo, 19060-900
About this study
Official title: Localized Muscle Resistance Test: Identification and Use of Parameters for Prescription of Exercise Resisted in Different Evaluation Tools
Introduction: Verification of the progression of individuals submitted to training programs is performed by diagnostic tests with a focus on strength and muscular endurance. Among the tools used are the elastic bands, the halter, the pulley, the digital dynamometer and, additionally, the isokinetic dynamometer, considered the gold standard of evaluation. However, there is a lack of standardization in assessments and scarcity in the exploration of some tools and some muscle groups. Observation is often restricted to a particular study design and makes comparisons difficult even with the use of the same tool. Thus, to include different clinical possibilities in the same scenario can enrich the discussion about the topic. Objective: To develop and analyze the validity and reliability of a maximal muscle strength test for the external rotator muscles of the shoulder in five tools; To develop and analyze the validity and reliability of a localized resistance test for the external rotator muscles of shoulder in three different percentages of maximum strength (60%, 70%, 80%) in four tools; To characterize by means of the physiological response the localized muscular endurance test with the load that presents with the highest reliability values in each tool. Method: The study will consist of a sample of 50 participants of both genders, and will be performed in 3 steps: (1) Validation and reliability of the maximum muscle strength test; (2) Reliability of the muscular endurance test (MET); (3) Physiological characterization of the muscular endurance test (MET). Stage 1 will be held in 3 sessions (familiarization, test and retest) in which participants will perform 5 tests of maximum strength with different tools (elastic bands, pulley, halter, digital dynamometer and isokinetic dynamometer). Stage 2, consisting of 6 sessions, will be tested and retest of a muscular endurance test with different loads (70%, 80% and 90% of maximum force) with the same devices of step 1, except the digital dynamometer. In Step 3 participants will be selected with the lowest variations between the test and retest in the variable "time" to perform the physiological characterization of the test with the different tools. In order to observe the physiological response, we will analyze the lactic anaerobic (lactate concentration), allelic anaerobic (post-exercise oxygen uptake (EPOC) and aerobic (VO 2 values) parameters). The statistical package SPSS Statistics 22.0 will be used to conduct the analyzes. Key words: Fatigue, Physical resistance, Muscle strength, Lactate.
- Conditions
- Fatigue
- Being tested
- Maximal muscle strength Test, Exhaustion test
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal muscle strength TestDiagnostic test
1RM test performed in 5 different tools (Elastic Band, Pulley, halter, digital dynamometer and isokinetic dynamometer)
Exhaustion testDiagnostic test
Test performed until individual exhaustion in 5 different tools (Elastic Band, Pulley, halter and isokinetic dynamometer)
| Study group | Role | What they receive |
|---|---|---|
| strength test | The maximum strength test of external shoulder rotators will be performed on 5 different tools with specific protocols. Receives: Diagnostic Test: Maximal muscle strength Test | |
| Endurance test | Test designed by the Laboratory of Sports Physical Therapy (LAFIDE) of FCT / UNESP - Presidente Prudente, used in the prescription of training for gain of localized muscular endurance. Will be realized in the tools: Isokinetic dynamometer, elastic bands, pulley and halter.
The test will consist of the maximum possible repetitions (until fatigue) with loads of 70%, 80% and 90% of the maximum force (in different sessions). Receives: Diagnostic Test: Exhaustion test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal force (kilograms)
The maximum force of the participant shall be measured with the values presented in kilogram
Measured: Stage 1 - 0 minutes after strength test
Time (seconds)
Measured: Stage 2 - 0 minutes after Endurance test
Number of repetitions
Measured: Stage 2 -0 minutes after Endurance test
Anthropometric evaluation
To determine the value corresponding to the body mass, the volunteers will be evaluated by a digital scale (Tanita BC554, Iron Man / Inner Scaner - Tanita, Illinois, United States). Stature values will be obtained by means of a stadiometer (Sanny - American Medical do Brasil, São Paulo, Brazil). From these values it will be possible to calculate the Body Mass Index (BMI), determined by the ratio of weight to height squared.
Measured: Stage 1 - 10 minutes before stregth test
Psychological Questionnaire
The questionnaire aims to subjectively document physical and metal readiness scores for exercise, fatigue, vigor, drowsiness, and muscle pain. Participants will be instructed to mark a dash on a visual analogue scale of 10 centimeters between two extremes, zero being "least possible" and 10 indicating "most possible" for each classification60. This questionnaire will be applied at the beginning of all sessions.
Measured: Stage 1 - 10 minutes before stregth test
International Physical Activity Questionnaire (IPAQ)
The IPAQ questionnaire is an instrument developed to estimate the level of habitual practice of physical activity. Sedentary - Does not perform any physical activity for at least 10 continuous minutes; Insufficiently Active - Individuals who engage in physical activity for at least 10 continuous minutes per week, but insufficiently to be classified as active. A) Perform 10 continuous minutes of physical activity, following at least one of the following criteria: frequency - 5 days/week or duration - 150 minutes/week; B) Does not meet any of the criteria of the recommendation cited in under-active individuals A; Active - a) vigorous physical activity - ≥ 3 days/week and ≥ 20 minutes/session; b) moderate or walking - ≥ 5 days/week and ≥ 30 minutes/session; c) any added activity: ≥ 5 day/week and ≥ 150 min/week; Very Active - a) vigorous - ≥ 5 days/week and ≥ 30 min/session; b) vigorous - ≥ 3 days/week and ≥ 20 min/session + moderate and or ≥ 5 days/week and ≥ 30 min/session.
Measured: Stage 1 - 10 minutes before stregth test
Borg's Perception of Effort Scale
The degree of subjective effort reported by the participants in relation to the upper limbs will be analyzed using the Borg scale of perception of effort of 6 to 20 points, 6 corresponding to the "very easy" and 20 to "exhaustive".
Measured: Stage 2 - 0 minutes after endurance test in all tools
Perceived effort
The perceived exertion of the resisted exercise will be evaluated through the OMNI Resistance Exercise Scale for Perceived Effort62,63, which consists of an ordinal scale of 0 to 10, 0 being extremely easy and 10 extremely difficult.
Measured: Stage 2 - 0 minutes after endurance test in all tools
Recovery Perception
The perception of recovery of the dominant lower limb will be evaluated through the Likert Scale of Recovery Perception, which consists of a scale with values between 1 and 10 points, 1 corresponding to no recovery and 10 to fully recovered
Measured: Stage 2 - 10 minutes after endurance test in all tools
Participation of the anaerobic parameter
The total participation of the anaerobic parameter (PANA) will be calculated by the sum of the lactary anaerobic (CLAC) and alactic (CALA) contributions, analyzed by [lac] and the excess of post-exercise oxygen consumption (EPOC), respectively.
Measured: Stage 3 - During endurance test, until 7 minutes after test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 Feb 2019
- Primary completion30 Jul 2019
- Study completion30 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jéssica Kirsch Michelleti, São Paulo State University
- Investigators
- Carlos Marcelo Pastre, PhD, Study director, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923608
- Sponsor's protocol ID
- SP-Unesp
- Status last verified
- Sep 2019
- First submitted
- 15 Apr 2019
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localized Muscle Resistance Test: Identification and Use of Parameters for Prescription of Exercise Resisted in Different Evaluation Tools
- ClinicalTrials.gov ID
- NCT03923608
- Acronym / sponsor ID
- SP-Unesp
- Conditions
- Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 22 Apr 2019 (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.
Introduction: Verification of the progression of individuals submitted to training programs is performed by diagnostic tests with a focus on strength and muscular endurance. Among the tools used are the elastic bands, the halter, the pulley, the digital dynamometer and, additionally, the isokinetic dynamometer, considered the gold standard of evaluation. However, there is a lack of standardization in assessments and scarcity in the exploration of some tools and some muscle groups. Observation is often restricted to a particular study design and makes comparisons difficult even with the use of the same tool. Thus, to include different clinical possibilities in the same scenario can enrich the discussion about the topic. Objective: To develop and analyze the validity and reliability of a maximal muscle strength test for the external rotator muscles of the shoulder in five tools; To develop and analyze the validity and reliability of a localized resistance test for the external rotator muscles of shoulder in three different percentages of maximum strength (60%, 70%, 80%) in four tools; To characterize by means of the physiological response the localized muscular endurance test with the load that presents with the highest reliability values in each tool. Method: The study will consist of a sample of 50 participants of both genders, and will be performed in 3 steps: (1) Validation and reliability of the maximum muscle strength test; (2) Reliability of the muscular endurance test (MET); (3) Physiological characterization of the muscular endurance test (MET). Stage 1 will be held in 3 sessions (familiarization, test and retest) in which participants will perform 5 tests of maximum strength with different tools (elastic bands, pulley, halter, digital dynamometer and isokinetic dynamometer). Stage 2, consisting of 6 sessions, will be tested and retest of a muscular endurance test with different loads (70%, 80% and 90% of maximum force) with the same devices of step 1, except the digital dynamometer. In Step 3 participants will be selected with the lowest variations between the test and retest in the variable "time" to perform the physiological characterization of the test with the different tools. In order to observe the physiological response, we will analyze the lactic anaerobic (lactate concentration), allelic anaerobic (post-exercise oxygen uptake (EPOC) and aerobic (VO 2 values) parameters). The statistical package SPSS Statistics 22.0 will be used to conduct the analyzes. Key words: Fatigue, Physical resistance, Muscle strength, Lactate.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| strength test | – | Diagnostic Test: Maximal muscle strength TestThe maximum strength test of external shoulder rotators will be performed on 5 different tools with specific protocols. |
| Endurance test | – | Diagnostic Test: Exhaustion testTest designed by the Laboratory of Sports Physical Therapy (LAFIDE) of FCT / UNESP - Presidente Prudente, used in the prescription of training for gain of localized muscular endurance. Will be realized in the tools: Isokinetic dynamometer, elastic bands, pulley and halter. The test will consist of the maximum possible repetitions (until fatigue) with loads of 70%, 80% and 90% of the maximum force (in different sessions). |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The sample is composed of apparently healthy young men, of both genders, between 13 and 30 years old.
Key inclusion criteria (4 listed)
- anemia,
- diabetes,
- cardiovascular disease,
- and upper limb and spinal muscular injuries in the last six months
Key exclusion criteria (2 listed)
- absence at any study session and
- episode of muscle-tendon or osteoarticular injury in the upper limbs during the study.
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 |
|---|---|---|
| Maximal muscle strength Test1RM test performed in 5 different tools (Elastic Band, Pulley, halter, digital dynamometer and isokinetic dynamometer) | Diagnostic test | strength test |
| Exhaustion testTest performed until individual exhaustion in 5 different tools (Elastic Band, Pulley, halter and isokinetic dynamometer) | Diagnostic test | Endurance test |
Primary outcome
Maximal force (kilograms)
Time frame: Stage 1 - 0 minutes after strength test
The maximum force of the participant shall be measured with the values presented in kilogram
Time (seconds)
Time frame: Stage 2 - 0 minutes after Endurance test
Number of repetitions
Time frame: Stage 2 -0 minutes after Endurance test
Anthropometric evaluation
Time frame: Stage 1 - 10 minutes before stregth test
To determine the value corresponding to the body mass, the volunteers will be evaluated by a digital scale (Tanita BC554, Iron Man / Inner Scaner - Tanita, Illinois, United States). Stature values will be obtained by means of a stadiometer (Sanny - American Medical do Brasil, São Paulo, Brazil). From these values it will be possible to calculate the Body Mass Index (BMI), determined by the ratio of weight to height squared.
Psychological Questionnaire
Time frame: Stage 1 - 10 minutes before stregth test
The questionnaire aims to subjectively document physical and metal readiness scores for exercise, fatigue, vigor, drowsiness, and muscle pain. Participants will be instructed to mark a dash on a visual analogue scale of 10 centimeters between two extremes, zero being "least possible" and 10 indicating "most possible" for each classification60. This questionnaire will be applied at the beginning of all sessions.
International Physical Activity Questionnaire (IPAQ)
Time frame: Stage 1 - 10 minutes before stregth test
The IPAQ questionnaire is an instrument developed to estimate the level of habitual practice of physical activity. Sedentary - Does not perform any physical activity for at least 10 continuous minutes; Insufficiently Active - Individuals who engage in physical activity for at least 10 continuous minutes per week, but insufficiently to be classified as active. A) Perform 10 continuous minutes of physical activity, following at least one of the following criteria: frequency - 5 days/week or duration - 150 minutes/week; B) Does not meet any of the criteria of the recommendation cited in under-active individuals A; Active - a) vigorous physical activity - ≥ 3 days/week and ≥ 20 minutes/session; b) moderate or walking - ≥ 5 days/week and ≥ 30 minutes/session; c) any added activity: ≥ 5 day/week and ≥ 150 min/week; Very Active - a) vigorous - ≥ 5 days/week and ≥ 30 min/session; b) vigorous - ≥ 3 days/week and ≥ 20 min/session + moderate and or ≥ 5 days/week and ≥ 30 min/session.
Borg's Perception of Effort Scale
Time frame: Stage 2 - 0 minutes after endurance test in all tools
The degree of subjective effort reported by the participants in relation to the upper limbs will be analyzed using the Borg scale of perception of effort of 6 to 20 points, 6 corresponding to the "very easy" and 20 to "exhaustive".
Perceived effort
Time frame: Stage 2 - 0 minutes after endurance test in all tools
The perceived exertion of the resisted exercise will be evaluated through the OMNI Resistance Exercise Scale for Perceived Effort62,63, which consists of an ordinal scale of 0 to 10, 0 being extremely easy and 10 extremely difficult.
Recovery Perception
Time frame: Stage 2 - 10 minutes after endurance test in all tools
The perception of recovery of the dominant lower limb will be evaluated through the Likert Scale of Recovery Perception, which consists of a scale with values between 1 and 10 points, 1 corresponding to no recovery and 10 to fully recovered
Participation of the anaerobic parameter
Time frame: Stage 3 - During endurance test, until 7 minutes after test
The total participation of the anaerobic parameter (PANA) will be calculated by the sum of the lactary anaerobic (CLAC) and alactic (CALA) contributions, analyzed by [lac] and the excess of post-exercise oxygen consumption (EPOC), respectively.
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 18 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
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.
Carlos Marcelo Pastre, PhD study director
Universidade Estadual Paulista Júlio de Mesquita Filho
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 Fatigue, run by São Paulo State University 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 4 inclusion and 2 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 18 Sep 2019. 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?
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?
Maximal force (kilograms) (time frame: Stage 1 - 0 minutes after strength test). The study lists 10 primary outcomes in all. 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 Sep 2019.