NCT05973396

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 2, 2023

Completed
Last Updated

August 2, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

November 8, 2022

Last Update Submit

August 1, 2023

Conditions

Keywords

Force ProductionMuscular FatigueMental Cognition

Outcome Measures

Primary Outcomes (1)

  • Average total height and force production of 5 Arms Fixed Countermovement jumps

    Average total height and force production of 5 Arms Fixed Countermovement jumps

    60 minutes

Secondary Outcomes (1)

  • Difference in mental math pre and post experiment scores

    60 minutes

Study Arms (2)

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

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

Other: Physical and Mental Fatiguing Task

Interventions

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

Also known as: Physical and Mental Fatiguing Task
Control: Physical Fatigue only

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)

Experiment: Mental and Physical Fatigue

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ParkerFit

Dallas, Texas, 75220, United States

Location

Parker University

Dallas, Texas, 75229, United States

Location

Related Links

MeSH Terms

Conditions

Mental FatigueMuscle Weakness

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

FatigueSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Study Officials

  • Katherine Pohlman, PhD

    Director of Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2022

First Posted

August 2, 2023

Study Start

July 18, 2022

Primary Completion

June 1, 2023

Study Completion

July 18, 2023

Last Updated

August 2, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations