Mental FatigueNCT05973396
The Effects of Mental and Physical Fatigue to Force Production in Adults
A study testing Physical Fatiguing Task only and Physical and Mental Fatiguing Task in people with Mental Fatigue and Muscle Weakness, run by Parker University at 2 sites in United States.
Trial summary
The primary objective is to investigate the correlation between physical and mental fatigue to lower extremity force production in adults to determine if there is an association of performance output that is inhibited by mental and physical stressors that mimic sport environments that can be further investigated to… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Mental Fatigue, Muscle Weakness
- What is being tested?
- Physical Fatiguing Task only and Physical and Mental Fatiguing Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jul 2022to 18 Jul 2023
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current students at Parker University from the ages of 21 to 65 years for safety concerns Children were not considered for this study Elderly were not considered for this study Current students who are currently physically active at least once a week
Who cannot join
- Anyone with who self reports previous history of cardiovascular issues or hospitalizations Rationale: Participants will be doing aerobic/ anaerobic efforts that will increase their heart rate Source: Redcap Questionnaire, Baseline visit
- Lower extremity surgery within the last two years Rationale: Puts participant more at risk of injury since inducing fatigue and a maximal power effort Source: Redcap Questionnaire, Baseline visit
- Medical restrictions for full activity Rationale: Puts participant more at risk of injury since inducing fatigue and a maximal power effort Source: Redcap Questionnaire, Baseline visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ParkerFit
Dallas, Texas, 75220
Parker University
Dallas, Texas, 75229
About this study
The primary objective is to investigate the correlation between physical and mental fatigue to lower extremity force production in adults to determine if there is an association of performance output that is inhibited by mental and physical stressors that mimic sport environments that can be further investigated to determine the importance of not only physical training and exercise for athletes, but also mental and cognitive exercises with physical task to enhance performance training and rehabilitation of individuals.
In adults, how does physical and mental fatigue in combination compared to those who are just physically fatigued affect average peak height in performance of five CMJ with hands on hips.
Read the detailed description
In terms of injury prevention mental or cognitive fatigue and altered biomechanics play a large role in risk of injury or reinjury. This can lead to disturbances in gait, balance or even It is known that there are decreases in rate of force production in a physically fatigued state.
However, this does not show if a mentally fatigued and physically fatigued individual have any negative implications towards a more dynamic and reactive test and conditions that mimic sport more than static balancing or linear walking. It is even noted in reactive times of post ACLr (one of the most common sports related injuries) have lower reactive times in agility test With ACLr having a high level or rate or reinjury on surgical side and nonsurgical side as well as known alterations of the cerebellum and specifically the primary sensory cortex.Understanding how much a mental and physical fatigue can impact reactive cognition and force production can be vital key in not only sports performance and management, but also risk or injury and be associated in the plan of returning an athlete to sport as power and force production is a key determinant of performance in many individual and team sports. It is noted that physical activities directly enhance mental fatigue significantly, but it is widely unresearched objectively how much or when physical fatigue directly impacts mental cognition and decision making properties to an individual. In sport it is crucial to act and react to be able to be successful. Multidirectional and team sports involve constant mental cognition in terms of visual, auditory interpretation and cognition, ability to recognize patterns and to finally physically perform tasks in a highly efficient manner.
The goal of an athlete is to be conditioned to play their best whether that is the first minute of the game or its last. That means making the correct decision and physically performing it. However, in a fatigued state can the athlete properly perform what is needed to be done in a safe and effective manner that is comparable to a not fatigued state.
- Conditions
- Mental Fatigue, Muscle Weakness
- Being tested
- Physical Fatiguing Task only, Physical and Mental Fatiguing Task
- Keywords
- Force Production, Muscular Fatigue, Mental Cognition
- Medical subject headings
- Mental Fatigue, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Fatiguing Task onlyOther
Also called Physical and Mental Fatiguing Task
Control group: 20-25 minutes [Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort] without mentally fatiguing task during low intensity effort pace
Physical and Mental Fatiguing TaskOther
Experimental group: 20-25 minutes [Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort] with mentally fatiguing task during low intensity effort pace (which includes: stroop test)
| Study group | Role | What they receive |
|---|---|---|
| Control: Physical Fatigue only | Active comparator | Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort Receives: Other: Physical Fatiguing Task only |
| Experiment: Mental and Physical Fatigue | Experimental | Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort with mentally fatiguing task during low intensity effort pace with stroop testing during 50 seconds Receives: Other: Physical and Mental Fatiguing Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average total height and force production of 5 Arms Fixed Countermovement jumps
Average total height and force production of 5 Arms Fixed Countermovement jumps
Measured: 60 minutes
Secondary outcomes (1)
Difference in mental math pre and post experiment scores
Difference in mental math pre and post experiment scores
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start18 Jul 2022
- Primary completion1 Jun 2023
- Study completion18 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katherine Pohlman, PhD, Study director, Director of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973396
- Sponsor's protocol ID
- PUIRB-2022-11
- Status last verified
- Aug 2023
- First submitted
- 8 Nov 2022
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mental and Physical Fatigue to Force Production in Adults
- ClinicalTrials.gov ID
- NCT05973396
- Acronym / sponsor ID
- PUIRB-2022-11
- Conditions
- Mental Fatigue, Muscle Weakness
- Keywords
- Force Production, Muscular Fatigue, Mental Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 18 Jul 2023 (actual)
- First posted
- 2 Aug 2023 (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.
The primary objective is to investigate the correlation between physical and mental fatigue to lower extremity force production in adults to determine if there is an association of performance output that is inhibited by mental and physical stressors that mimic sport environments that can be further investigated to determine the importance of not only physical training and exercise for athletes, but also mental and cognitive exercises with physical task to enhance performance training and rehabilitation of individuals.
In adults, how does physical and mental fatigue in combination compared to those who are just physically fatigued affect average peak height in performance of five CMJ with hands on hips.
Detailed description
In terms of injury prevention mental or cognitive fatigue and altered biomechanics play a large role in risk of injury or reinjury. This can lead to disturbances in gait, balance or even It is known that there are decreases in rate of force production in a physically fatigued state.
However, this does not show if a mentally fatigued and physically fatigued individual have any negative implications towards a more dynamic and reactive test and conditions that mimic sport more than static balancing or linear walking. It is even noted in reactive times of post ACLr (one of the most common sports related injuries) have lower reactive times in agility test With ACLr having a high level or rate or reinjury on surgical side and nonsurgical side as well as known alterations of the cerebellum and specifically the primary sensory cortex.Understanding how much a mental and physical fatigue can impact reactive cognition and force production can be vital key in not only sports performance and management, but also risk or injury and be associated in the plan of returning an athlete to sport as power and force production is a key determinant of performance in many individual and team sports. It is noted that physical activities directly enhance mental fatigue significantly, but it is widely unresearched objectively how much or when physical fatigue directly impacts mental cognition and decision making properties to an individual. In sport it is crucial to act and react to be able to be successful. Multidirectional and team sports involve constant mental cognition in terms of visual, auditory interpretation and cognition, ability to recognize patterns and to finally physically perform tasks in a highly efficient manner.
The goal of an athlete is to be conditioned to play their best whether that is the first minute of the game or its last. That means making the correct decision and physically performing it. However, in a fatigued state can the athlete properly perform what is needed to be done in a safe and effective manner that is comparable to a not fatigued state.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control: Physical Fatigue only | Active comparator | Other: Physical Fatiguing Task onlyRogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort |
| Experiment: Mental and Physical Fatigue | Experimental | Other: Physical and Mental Fatiguing TaskRogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort with mentally fatiguing task during low intensity effort pace with stroop testing during 50 seconds |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Current students at Parker University from the ages of 21 to 65 years for safety concerns Children were not considered for this study Elderly were not considered for this study Current students who are currently physically active at least once a week
Key exclusion criteria (3 listed)
- Anyone with who self reports previous history of cardiovascular issues or hospitalizations Rationale: Participants will be doing aerobic/ anaerobic efforts that will increase their heart rate Source: Redcap Questionnaire, Baseline visit
- Lower extremity surgery within the last two years Rationale: Puts participant more at risk of injury since inducing fatigue and a maximal power effort Source: Redcap Questionnaire, Baseline visit
- Medical restrictions for full activity Rationale: Puts participant more at risk of injury since inducing fatigue and a maximal power effort Source: Redcap Questionnaire, Baseline visit
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 |
|---|---|---|
| Physical Fatiguing Task onlyAlso: Physical and Mental Fatiguing TaskControl group: 20-25 minutes [Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort] without mentally fatiguing task during low intensity effort pace | Other | Control: Physical Fatigue only |
| Physical and Mental Fatiguing TaskExperimental group: 20-25 minutes [Rogue Echo Bike 20 intervals of 10 second of maximal-submaximal effort to 50 seconds of recovery low intensity effort] with mentally fatiguing task during low intensity effort pace (which includes: stroop test) | Other | Experiment: Mental and Physical Fatigue |
Primary outcome
Average total height and force production of 5 Arms Fixed Countermovement jumps
Time frame: 60 minutes
Average total height and force production of 5 Arms Fixed Countermovement jumps
1 secondary outcome
Difference in mental math pre and post experiment scores
Time frame: 60 minutes
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 2 Aug 2023.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- 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.
Katherine Pohlman, PhD study director
Director of Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Fatiguing Task only and Physical and Mental Fatiguing Task in people with Mental Fatigue and Muscle Weakness, run by Parker University at 2 sites 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 3 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Average total height and force production of 5 Arms Fixed Countermovement jumps (time frame: 60 minutes). 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 2 Aug 2023.