FatigueNCT03495752
The Effect of Fatigue on the Forward-Step-Down Test
A study testing Bruce Fatigue Protocol in people with Fatigue, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
Trial summary
This study investigates the effect that performing a cardiovascular maximum effort test (the Bruce treadmill protocol) has on performance of the Forward-Step-Down Test (FSDT). The FSDT is performed prior to the fatigue protocol as a baseline measurement, then at 1, 5, and 10 minutes after the fatigue protocol. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Bruce Fatigue Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2018to 29 Jun 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants will be recruited from current physical therapy students in the class of 2020 who are enrolled in PHTH 7565. During the consent process, the participants will be screened using the American College of Sports Medicine's guidelines for safe participation in vigorous exercise. By meeting the ACSM criteria, the participant is considered low risk for adverse events while participating in vigorous activity. Finally, in order for the student to participate, they must achieve within 10 bpm of their predicted maximum heart rate, as calculated by the Tanaka formula as stated above.
Who cannot join
- 3.2 Exclusion criteria are pre-existing cardiovascular conditions or diseases that prevent participation in a maximal effort test without physician clearance per the ACSM guidelines. Participants who do not reach their calculated target heart rate by the end of the Bruce protocol will be withdrawn from the study and will not complete post-fatigue testing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Cardiovascular Fatigue on Performance of the Forward-Step-Down Test
This study investigates the effect that performing a cardiovascular maximum effort test (the Bruce treadmill protocol) has on performance of the Forward-Step-Down Test (FSDT). The FSDT is performed prior to the fatigue protocol as a baseline measurement, then at 1, 5, and 10 minutes after the fatigue protocol. Participants much reach a certain heart rate (within 10 bpm) of their age predicted maximum heart rate to ensure that the fatigue protocol reaches a maximum fatiguing effort.
Read the detailed description
The purpose of this study is to investigate the effects that a volitional maximal cardiovascular exertion test (the Bruce Treadmill Protocol) has on performance of the Forward-Step-Down (FSD) test, and to investigate how performance on the FSD test changes at multiple time points following the fatigue test.
Our hypotheses for this study are as follows:
- Null (H0): Participants will not demonstrate a change in score on the FSD test after performance of the Bruce test at any time point.
- Alternate (H1): Participants will demonstrate a change in score on the FSD test after performance of the Bruce test at one or multiple of the repeated measurements.
The FSD test has been shown to correlate with movement quality. Deficits in strength and flexibility that result in movement impairments are associated with scores on the test delineating "moderate" movement quality. Fatigue may play a role in increased injury risk, with fatigued participants in numerous studies showing compromised movement patterns that increase risk of injury. At this time, many of the screening tools used to determine the impact of fatigue on a player's ability to continue to play/practice involved dynamic or explosive movements, and rely on indicators such as femoral internal rotation or hip adduction angles at initial contact to grade movement patterns. These biomechanical indicators may be difficult for non-professional personnel to observe, limiting their use outside a clinic. There is currently no research on the role of the FSD test in assessing for changes in movement pattern that result from fatigue.
The literature currently acknowledges that fatigue results in altered movement patterns. Several studies have investigated the impact that fatigue has on performing challenging movements, such as plyometric drop jumps, cutting, jumping and running, and landing. However, with higher level assessments such as these, there is an increased risk for injury if performed while fatigued. Therefore, a lower level test, such as the FSD test, would be ideal as a safe and effective screening tool to look at the impact of fatigue stimulus (game play) on a person's movement quality. As stated above, the FSD test has been validated as a measure of movement quality, with acceptable interrater reliability. In addition, poor movement quality during the FSD test has been shown to correlate with several impairments such as hip abductor strength and poor flexibility. Existing literature discusses the impact of the hip abductors on knee position and risk for knee injury. Therefore, a functional test that assesses not only movement quality but identifies possible causes of poor movement would be ideal for preventing injury. Research has shown difference in postural balance following aerobic fatigue depending on the time since fatigue, with poor performance immediately following but improved performance 10 minutes after the fatigue stimulus was stopped. Therefore, this study will examine the FSD test at one, five, and ten minutes following the cardiovascular fatigue protocol in order to discern performance differences in movement quality related to time/recovery. These differences may be important because if the FSD test can be used as a screening tool to examine a person's fatigue level, it is important to also know the appropriate time to use the test in order to get accurate results.
In this study, the Bruce test is used to achieve cardiovascular fatigue. Clinically it is a "VO2max" (maximum volume of oxygen consumption) prediction test and is intended to continue to the point of failure (maximum test). In a true VO2max test, the participant performs the cardiovascular test until respiratory spirometry measures a plateau of the VO2, or oxygen consumption, between two workloads. This is indicative of that participant's maximum cardiovascular physiological limits. During a true VO2max test, respiratory gases are analyzed as well as heart rate, blood pressure, and sometimes blood lactate samples are obtained. Together these values determine the success in reaching a true VO2max test, demonstrate cardiovascular fatigue, and ensure safety of the participant. Often, this point is not reached in untrained or unhealthy individuals.
Performing a true VO2max test is more expensive and time-consuming for the participant than performing a maximal or submaximal graded exercise test. Therefore, the Bruce protocol uses mathematical derivation to predict VO2max from the participant's performance on the Bruce. To estimate an accurate prediction of the VO2max and ensure cardiovascular fatigue, the target heart rate is often set at within 10 bpm of the age-predicted maximum heart rate when using a lower error formula such as the Tanaka formula. Therefore, in this study participants' age-predicted maximum heart rate will be calculated using the formula derived by Tanaka with an acceptable variability of within 10 bpm at the maximum heart rate measured during the Bruce. The Tanaka formula is accurate for a population of healthy men and women. In this study, "healthy" is defined as being in the "low risk" category for exercise as stated by the American College of Sports Medicine, and is one of the inclusion criteria for this study.
- Prior to performing the testing, participants will be consented and screened for inclusion and exclusion criteria at the end of an exercise physiology class during the summer 2018 semester. This will occur before the students begin their exercise testing labs in which the Bruce protocol is performed. Following consenting, participants will proceed to the testing during the four-week data collection period during the summer 2018 semester.
- Each participant will perform the pre-and post-testing in the same day. The pre-fatigue FSD test occurs just prior to the fatigue (Bruce) protocol, and the post-testing will occur at one, five, and ten minutes after completion of the fatigue protocol. Initial resting heart rate will be measured, as will heart rate at 0, 30, and 60 seconds following completion of the Bruce to ensure appropriate heart rate responses to exercise for a healthy young adult as per the inclusion criteria of participants being "low risk" for adverse events during vigorous exercise.
- The expected duration to obtain all necessary participants is up to 4 weeks.
- The estimated time for the researches to perform the primary analysis is 3 months
- The estimated time to prepare the manuscript for publication is 1 year.
This study will be a repeated-measures design, with all participants undergoing both pre- and post-fatigue FSD test assessments. Two orthopaedic specialist physical therapists will perform the FSD assessments. The investigators will review scoring guidelines per the Park article, and will practice scoring the test prior to data collection to ensure good interrater reliability. Scores on the FSD test from each assessor will be averaged after data collection and prior to data analysis, with each assessor blinded to the other's score prior to averaging the scores. Participants will be healthy physical therapy students. Fatigue will be induced via the Bruce protocol used in assessment of maximum cardiovascular capacity. The treadmill used is an HP Cosmos Quasar (HP Cosmos, Germany). The heart rate monitors used are Polar monitors (Polar Electro Inc, Bethpage, NY)
The FSD test grades the participant on movement quality during a repeated step down from a 20 cm step. The weight bearing leg will be the dominant leg (the leg the participant would use to kick a ball) as used in the Park et al experiment. The FSD test consists of five repeated movements of the forward step down, with one score given for the whole set of five repetitions. For each set of five movements, the rater observes and produces one score for that set of five movements. For data analysis, the investigators will use the average of each score for each FSD test. For example, on the pre-test for a participant, if one investigator scored the pre-test FSD a 2/6, and the second investigator scored the pre-test a 1/6, the "averaged" score for the participant's pre-test is a 1.5/6. This same procedure would be repeated for the three post-test FSD tests.
The Bruce protocol is self-limited with participants stopping at maximal exertion. Maximal exertion will be defined as within 10 bpm of the participants predicted maximum heartrate as calculated by the formula "208-(0.7 x age)" derived by Tanaka from a population of healthy men and women. The within 10 bpm heart rate cutoff has been used as a benchmark of achieving maximal exertion in a maximal exercise test based off the calculated maximum heart rate using the Tanaka formula. The participants' Borg Rating of Perceived Exertion (RPE) will also be recorded as part of the Bruce protocol; however, since the participants know they will have to perform the FSD test following the Bruce protocol, the investigators will use heart rate instead of RPE as a metric for exertion due to its more objective nature and to avoid a possible threat to validity of the fatigue protocol. During the Bruce protocol, treadmill speed and incline are increased every three minutes until the subject volitionally stops the test at maximal exertion. Heart rate and RPE are monitored each minute during the Bruce protocol, with assessment of blood pressure prior and following the treadmill test as part of the Exercise Physiology class.
- Conditions
- Fatigue
- Being tested
- Bruce Fatigue Protocol
- Keywords
- muscle performance, injury prevention, step down, fatigue
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bruce Fatigue ProtocolOther
Participant will perform the Bruce protocol as a fatigue stimulus to examine the impact of fatigue on the FSDT
| Study group | Role | What they receive |
|---|---|---|
| Pre/Post Repeated Measures | Experimental | Performance on the forward-step-down test (FSDT) before and at one, five, and ten minutes following the Bruce Fatigue Protocol Receives: Other: Bruce Fatigue Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on the Forward-Step-Down Test
The participants' scores on the pre-test FSDT will be compared to their scores post-test measured at 1, 5, and 10 minutes after the fatigue stimulus
Measured: up to 10 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start21 Jun 2018
- Primary completion29 Jun 2018
- Study completion29 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center Shreveport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin N. McCallister, Louisiana State University Health Sciences Center Shreveport
- Investigators
- Erin McCallister, DPT, Principal investigator, LSUHSC-Shreveport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495752
- Sponsor's protocol ID
- STUDY00000949
- Status last verified
- Aug 2019
- First submitted
- 4 Apr 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Park KM, Cynn HS, Choung SD. Musculoskeletal predictors of movement quality for the forward step-down test in asymptomatic women. J Orthop Sports Phys Ther. 2013;43(7):504-10. doi: 10.2519/jospt.2013.4073. Epub 2013 Jun 11.
PubMed 23756380Cortes N, Greska E, Kollock R, Ambegaonkar J, Onate JA. Changes in lower extremity biomechanics due to a short-term fatigue protocol. J Athl Train. 2013 May-Jun;48(3):306-13. doi: 10.4085/1062-6050-48.2.03. Epub 2013 Feb 20.
PubMed 23675789Geiser CF, O'Connor KM, Earl JE. Effects of isolated hip abductor fatigue on frontal plane knee mechanics. Med Sci Sports Exerc. 2010 Mar;42(3):535-45. doi: 10.1249/MSS.0b013e3181b7b227.
PubMed 19952814Johnston RB 3rd, Howard ME, Cawley PW, Losse GM. Effect of lower extremity muscular fatigue on motor control performance. Med Sci Sports Exerc. 1998 Dec;30(12):1703-7. doi: 10.1097/00005768-199812000-00008.
PubMed 9861603McLean SG, Samorezov JE. Fatigue-induced ACL injury risk stems from a degradation in central control. Med Sci Sports Exerc. 2009 Aug;41(8):1661-72. doi: 10.1249/MSS.0b013e31819ca07b.
PubMed 19568192Mohammadi F, Roozdar A. Effects of fatigue due to contraction of evertor muscles on the ankle joint position sense in male soccer players. Am J Sports Med. 2010 Apr;38(4):824-8. doi: 10.1177/0363546509354056. Epub 2010 Feb 5.
PubMed 20139329Wesley CA, Aronson PA, Docherty CL. Lower Extremity Landing Biomechanics in Both Sexes After a Functional Exercise Protocol. J Athl Train. 2015 Sep;50(9):914-20. doi: 10.4085/1062-6050-50.8.03. Epub 2015 Aug 18.
PubMed 26285090Moran KA, Clarke M, Reilly F, Wallace ES, Brabazon D, Marshall B. Does endurance fatigue increase the risk of injury when performing drop jumps? J Strength Cond Res. 2009 Aug;23(5):1448-55. doi: 10.1519/JSC.0b013e3181a4e9fa.
PubMed 19620920Padulo J, Attene G, Ardigo LP, Bragazzi NL, Maffulli N, Zagatto AM, Dello Iacono A. Can a Repeated Sprint Ability Test Help Clear a Previously Injured Soccer Player for Fully Functional Return to Activity? A Pilot Study. Clin J Sport Med. 2017 Jul;27(4):361-368. doi: 10.1097/JSM.0000000000000368.
PubMed 27428681Ros AG, Holm SE, Friden C, Heijne AI. Responsiveness of the one-leg hop test and the square hop test to fatiguing intermittent aerobic work and subsequent recovery. J Strength Cond Res. 2013 Apr;27(4):988-94. doi: 10.1519/JSC.0b013e31825feb5b.
PubMed 22706574Herman G, Nakdimon O, Levinger P, Springer S. Agreement of an Evaluation of the Forward-Step-Down Test by a Broad Cohort of Clinicians With That of an Expert Panel. J Sport Rehabil. 2016 Aug;25(3):227-32. doi: 10.1123/jsr.2014-0319. Epub 2015 Dec 14.
PubMed 26655963Steinberg N, Eliakim A, Zaav A, Pantanowitz M, Halumi M, Eisenstein T, Meckel Y, Nemet D. Postural Balance Following Aerobic Fatigue Tests: A Longitudinal Study Among Young Athletes. J Mot Behav. 2016 Jul-Aug;48(4):332-40. doi: 10.1080/00222895.2015.1095153. Epub 2016 Jan 5.
PubMed 26731202ACSM's Guidelines for Exercise Testing and Prescription. 10 ed. Philadelphia, PA: Wolters Kluwer; 2018.
Beltz NM, Gibson AL, Janot JM, Kravitz L, Mermier CM, Dalleck LC. Graded Exercise Testing Protocols for the Determination of VO2max: Historical Perspectives, Progress, and Future Considerations. J Sports Med (Hindawi Publ Corp). 2016;2016:3968393. doi: 10.1155/2016/3968393. Epub 2016 Dec 25.
PubMed 28116349Tanaka H, Monahan KD, Seals DR. Age-predicted maximal heart rate revisited. J Am Coll Cardiol. 2001 Jan;37(1):153-6. doi: 10.1016/s0735-1097(00)01054-8.
PubMed 11153730
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cardiovascular Fatigue on Performance of the Forward-Step-Down Test
- ClinicalTrials.gov ID
- NCT03495752
- Acronym / sponsor ID
- STUDY00000949
- Conditions
- Fatigue
- Keywords
- muscle performance, injury prevention, step down, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center ShreveportUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Jun 2019 (actual)
- First posted
- 12 Apr 2018 (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.
This study investigates the effect that performing a cardiovascular maximum effort test (the Bruce treadmill protocol) has on performance of the Forward-Step-Down Test (FSDT). The FSDT is performed prior to the fatigue protocol as a baseline measurement, then at 1, 5, and 10 minutes after the fatigue protocol. Participants much reach a certain heart rate (within 10 bpm) of their age predicted maximum heart rate to ensure that the fatigue protocol reaches a maximum fatiguing effort.
Detailed description
The purpose of this study is to investigate the effects that a volitional maximal cardiovascular exertion test (the Bruce Treadmill Protocol) has on performance of the Forward-Step-Down (FSD) test, and to investigate how performance on the FSD test changes at multiple time points following the fatigue test.
Our hypotheses for this study are as follows:
- Null (H0): Participants will not demonstrate a change in score on the FSD test after performance of the Bruce test at any time point.
- Alternate (H1): Participants will demonstrate a change in score on the FSD test after performance of the Bruce test at one or multiple of the repeated measurements.
The FSD test has been shown to correlate with movement quality. Deficits in strength and flexibility that result in movement impairments are associated with scores on the test delineating "moderate" movement quality. Fatigue may play a role in increased injury risk, with fatigued participants in numerous studies showing compromised movement patterns that increase risk of injury. At this time, many of the screening tools used to determine the impact of fatigue on a player's ability to continue to play/practice involved dynamic or explosive movements, and rely on indicators such as femoral internal rotation or hip adduction angles at initial contact to grade movement patterns. These biomechanical indicators may be difficult for non-professional personnel to observe, limiting their use outside a clinic. There is currently no research on the role of the FSD test in assessing for changes in movement pattern that result from fatigue.
The literature currently acknowledges that fatigue results in altered movement patterns. Several studies have investigated the impact that fatigue has on performing challenging movements, such as plyometric drop jumps, cutting, jumping and running, and landing. However, with higher level assessments such as these, there is an increased risk for injury if performed while fatigued. Therefore, a lower level test, such as the FSD test, would be ideal as a safe and effective screening tool to look at the impact of fatigue stimulus (game play) on a person's movement quality. As stated above, the FSD test has been validated as a measure of movement quality, with acceptable interrater reliability. In addition, poor movement quality during the FSD test has been shown to correlate with several impairments such as hip abductor strength and poor flexibility. Existing literature discusses the impact of the hip abductors on knee position and risk for knee injury. Therefore, a functional test that assesses not only movement quality but identifies possible causes of poor movement would be ideal for preventing injury. Research has shown difference in postural balance following aerobic fatigue depending on the time since fatigue, with poor performance immediately following but improved performance 10 minutes after the fatigue stimulus was stopped. Therefore, this study will examine the FSD test at one, five, and ten minutes following the cardiovascular fatigue protocol in order to discern performance differences in movement quality related to time/recovery. These differences may be important because if the FSD test can be used as a screening tool to examine a person's fatigue level, it is important to also know the appropriate time to use the test in order to get accurate results.
In this study, the Bruce test is used to achieve cardiovascular fatigue. Clinically it is a "VO2max" (maximum volume of oxygen consumption) prediction test and is intended to continue to the point of failure (maximum test). In a true VO2max test, the participant performs the cardiovascular test until respiratory spirometry measures a plateau of the VO2, or oxygen consumption, between two workloads. This is indicative of that participant's maximum cardiovascular physiological limits. During a true VO2max test, respiratory gases are analyzed as well as heart rate, blood pressure, and sometimes blood lactate samples are obtained. Together these values determine the success in reaching a true VO2max test, demonstrate cardiovascular fatigue, and ensure safety of the participant. Often, this point is not reached in untrained or unhealthy individuals.
Performing a true VO2max test is more expensive and time-consuming for the participant than performing a maximal or submaximal graded exercise test. Therefore, the Bruce protocol uses mathematical derivation to predict VO2max from the participant's performance on the Bruce. To estimate an accurate prediction of the VO2max and ensure cardiovascular fatigue, the target heart rate is often set at within 10 bpm of the age-predicted maximum heart rate when using a lower error formula such as the Tanaka formula. Therefore, in this study participants' age-predicted maximum heart rate will be calculated using the formula derived by Tanaka with an acceptable variability of within 10 bpm at the maximum heart rate measured during the Bruce. The Tanaka formula is accurate for a population of healthy men and women. In this study, "healthy" is defined as being in the "low risk" category for exercise as stated by the American College of Sports Medicine, and is one of the inclusion criteria for this study.
- Prior to performing the testing, participants will be consented and screened for inclusion and exclusion criteria at the end of an exercise physiology class during the summer 2018 semester. This will occur before the students begin their exercise testing labs in which the Bruce protocol is performed. Following consenting, participants will proceed to the testing during the four-week data collection period during the summer 2018 semester.
- Each participant will perform the pre-and post-testing in the same day. The pre-fatigue FSD test occurs just prior to the fatigue (Bruce) protocol, and the post-testing will occur at one, five, and ten minutes after completion of the fatigue protocol. Initial resting heart rate will be measured, as will heart rate at 0, 30, and 60 seconds following completion of the Bruce to ensure appropriate heart rate responses to exercise for a healthy young adult as per the inclusion criteria of participants being "low risk" for adverse events during vigorous exercise.
- The expected duration to obtain all necessary participants is up to 4 weeks.
- The estimated time for the researches to perform the primary analysis is 3 months
- The estimated time to prepare the manuscript for publication is 1 year.
This study will be a repeated-measures design, with all participants undergoing both pre- and post-fatigue FSD test assessments. Two orthopaedic specialist physical therapists will perform the FSD assessments. The investigators will review scoring guidelines per the Park article, and will practice scoring the test prior to data collection to ensure good interrater reliability. Scores on the FSD test from each assessor will be averaged after data collection and prior to data analysis, with each assessor blinded to the other's score prior to averaging the scores. Participants will be healthy physical therapy students. Fatigue will be induced via the Bruce protocol used in assessment of maximum cardiovascular capacity. The treadmill used is an HP Cosmos Quasar (HP Cosmos, Germany). The heart rate monitors used are Polar monitors (Polar Electro Inc, Bethpage, NY)
The FSD test grades the participant on movement quality during a repeated step down from a 20 cm step. The weight bearing leg will be the dominant leg (the leg the participant would use to kick a ball) as used in the Park et al experiment. The FSD test consists of five repeated movements of the forward step down, with one score given for the whole set of five repetitions. For each set of five movements, the rater observes and produces one score for that set of five movements. For data analysis, the investigators will use the average of each score for each FSD test. For example, on the pre-test for a participant, if one investigator scored the pre-test FSD a 2/6, and the second investigator scored the pre-test a 1/6, the "averaged" score for the participant's pre-test is a 1.5/6. This same procedure would be repeated for the three post-test FSD tests.
The Bruce protocol is self-limited with participants stopping at maximal exertion. Maximal exertion will be defined as within 10 bpm of the participants predicted maximum heartrate as calculated by the formula "208-(0.7 x age)" derived by Tanaka from a population of healthy men and women. The within 10 bpm heart rate cutoff has been used as a benchmark of achieving maximal exertion in a maximal exercise test based off the calculated maximum heart rate using the Tanaka formula. The participants' Borg Rating of Perceived Exertion (RPE) will also be recorded as part of the Bruce protocol; however, since the participants know they will have to perform the FSD test following the Bruce protocol, the investigators will use heart rate instead of RPE as a metric for exertion due to its more objective nature and to avoid a possible threat to validity of the fatigue protocol. During the Bruce protocol, treadmill speed and incline are increased every three minutes until the subject volitionally stops the test at maximal exertion. Heart rate and RPE are monitored each minute during the Bruce protocol, with assessment of blood pressure prior and following the treadmill test as part of the Exercise Physiology class.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre/Post Repeated Measures | Experimental | Other: Bruce Fatigue ProtocolPerformance on the forward-step-down test (FSDT) before and at one, five, and ten minutes following the Bruce Fatigue Protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be recruited from current physical therapy students in the class of 2020 who are enrolled in PHTH 7565. During the consent process, the participants will be screened using the American College of Sports Medicine's guidelines for safe participation in vigorous exercise. By meeting the ACSM criteria, the participant is considered low risk for adverse events while participating in vigorous activity. Finally, in order for the student to participate, they must achieve within 10 bpm of their predicted maximum heart rate, as calculated by the Tanaka formula as stated above.
Key exclusion criteria (1 listed)
- 3.2 Exclusion criteria are pre-existing cardiovascular conditions or diseases that prevent participation in a maximal effort test without physician clearance per the ACSM guidelines. Participants who do not reach their calculated target heart rate by the end of the Bruce protocol will be withdrawn from the study and will not complete post-fatigue testing.
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 |
|---|---|---|
| Bruce Fatigue ProtocolParticipant will perform the Bruce protocol as a fatigue stimulus to examine the impact of fatigue on the FSDT | Other | Pre/Post Repeated Measures |
Primary outcome
Change in Score on the Forward-Step-Down Test
Time frame: up to 10 minutes after intervention
The participants' scores on the pre-test FSDT will be compared to their scores post-test measured at 1, 5, and 10 minutes after the fatigue stimulus
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 13 Aug 2019.
- Background: PubMed 23756380Park KM, Cynn HS, Choung SD. Musculoskeletal predictors of movement quality for the forward step-down test in asymptomatic women. J Orthop Sports Phys Ther. 2013;43(7):504-10. doi: 10.2519/jospt.2013.4073. Epub 2013 Jun 11.
- Background: PubMed 23675789Cortes N, Greska E, Kollock R, Ambegaonkar J, Onate JA. Changes in lower extremity biomechanics due to a short-term fatigue protocol. J Athl Train. 2013 May-Jun;48(3):306-13. doi: 10.4085/1062-6050-48.2.03. Epub 2013 Feb 20.
- Background: PubMed 19952814Geiser CF, O'Connor KM, Earl JE. Effects of isolated hip abductor fatigue on frontal plane knee mechanics. Med Sci Sports Exerc. 2010 Mar;42(3):535-45. doi: 10.1249/MSS.0b013e3181b7b227.
- Background: PubMed 9861603Johnston RB 3rd, Howard ME, Cawley PW, Losse GM. Effect of lower extremity muscular fatigue on motor control performance. Med Sci Sports Exerc. 1998 Dec;30(12):1703-7. doi: 10.1097/00005768-199812000-00008.
- Background: PubMed 19568192McLean SG, Samorezov JE. Fatigue-induced ACL injury risk stems from a degradation in central control. Med Sci Sports Exerc. 2009 Aug;41(8):1661-72. doi: 10.1249/MSS.0b013e31819ca07b.
- Background: PubMed 20139329Mohammadi F, Roozdar A. Effects of fatigue due to contraction of evertor muscles on the ankle joint position sense in male soccer players. Am J Sports Med. 2010 Apr;38(4):824-8. doi: 10.1177/0363546509354056. Epub 2010 Feb 5.
- Background: PubMed 26285090Wesley CA, Aronson PA, Docherty CL. Lower Extremity Landing Biomechanics in Both Sexes After a Functional Exercise Protocol. J Athl Train. 2015 Sep;50(9):914-20. doi: 10.4085/1062-6050-50.8.03. Epub 2015 Aug 18.
- Background: PubMed 19620920Moran KA, Clarke M, Reilly F, Wallace ES, Brabazon D, Marshall B. Does endurance fatigue increase the risk of injury when performing drop jumps? J Strength Cond Res. 2009 Aug;23(5):1448-55. doi: 10.1519/JSC.0b013e3181a4e9fa.
- Background: PubMed 27428681Padulo J, Attene G, Ardigo LP, Bragazzi NL, Maffulli N, Zagatto AM, Dello Iacono A. Can a Repeated Sprint Ability Test Help Clear a Previously Injured Soccer Player for Fully Functional Return to Activity? A Pilot Study. Clin J Sport Med. 2017 Jul;27(4):361-368. doi: 10.1097/JSM.0000000000000368.
- Background: PubMed 22706574Ros AG, Holm SE, Friden C, Heijne AI. Responsiveness of the one-leg hop test and the square hop test to fatiguing intermittent aerobic work and subsequent recovery. J Strength Cond Res. 2013 Apr;27(4):988-94. doi: 10.1519/JSC.0b013e31825feb5b.
- Background: PubMed 26655963Herman G, Nakdimon O, Levinger P, Springer S. Agreement of an Evaluation of the Forward-Step-Down Test by a Broad Cohort of Clinicians With That of an Expert Panel. J Sport Rehabil. 2016 Aug;25(3):227-32. doi: 10.1123/jsr.2014-0319. Epub 2015 Dec 14.
- Background: PubMed 26731202Steinberg N, Eliakim A, Zaav A, Pantanowitz M, Halumi M, Eisenstein T, Meckel Y, Nemet D. Postural Balance Following Aerobic Fatigue Tests: A Longitudinal Study Among Young Athletes. J Mot Behav. 2016 Jul-Aug;48(4):332-40. doi: 10.1080/00222895.2015.1095153. Epub 2016 Jan 5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Erin McCallister, DPT principal investigator
LSUHSC-Shreveport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bruce Fatigue Protocol in people with Fatigue, run by Louisiana State University Health Sciences Center Shreveport at 1 site in United States.
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 1 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 13 Aug 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 United States. 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?
Change in Score on the Forward-Step-Down Test (time frame: up to 10 minutes after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03495752, which also lists 16 linked publications.
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 13 Aug 2019.