Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479265
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2024-06-13
Brief Title:
Manipulating Cognitive Intensity During Aerobic Exercise
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Manipulating the Wisconsin Card Sorting Task Using Virtual Reality to Challenge Executive Function
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the performance effects of manipulating the properties of a cognitively engaging aerobic task The overall goal of this proposal is to determine how changes in aspects of the task selection time number of sorting options and inclusion of different dual task walking interferences can be used to challenge the cognitive domain of executive function in a range of healthy adults The investigators hope to learn how to challenge people cognitively during exercise to promote mental benefits Participants are invited as a possible participant because are a healthy adult 40 participants will take part in the study This research is being funded by the Clinical Exercise Research Center CERC in the Division of Biokinesiology and Physical Therapy on the University of Southern California Health Sciences Campus
Detailed Description:
PURPOSE
The purpose of this study is to investigate the performance effects of manipulating the properties of a cognitively engaging aerobic task The overall goal of this proposal is to determine how changes in aspects of the task selection time number of sorting options and inclusion of different dual task walking interferences can be used to challenge the cognitive domain of executive function in a range of healthy adults The investigators hope to learn how to challenge people cognitively during exercise to promote mental benefits Participants are invited as a possible participant because are a healthy adult 40 participants will take part in the study This research is being funded by the Clinical Exercise Research Center CERC in the Division of Biokinesiology and Physical Therapy on the University of Southern California Health Sciences Campus
PROCEDURES
If participants decide to take part this is what will happen
Study Visit Participants will report to the CERC and read the informed consent with a study investigator Participants will be given the opportunity to ask any questions about the study If participants are willing to take part in the study the participant will sign this informed consent agreeing to participate Participants training intervention task will then be randomized All participants will participate in the same training but in different orders At this start of the visit the investigators will use questionnaires to determine eligibility to participate in the full study Participants will undergo the following assessments Approximate time 15 hours
Physical Activity Readiness Questionnaire PAR-Q This is a common method of uncovering health and lifestyle issues before starting an exercise program This short questionnaire will be used to reveals history of illness and if an issue is revealed it is advisable to seek doctors advice before participating in exercise excluding participants from this study
Prescreen Questionnaire Prescreening should be conducted before immersion because there are pre-existing conditions that may increase the likelihood of side effects Therefore participants will complete a brief questionnaire to identify any pre-existing conditions that would exclude participants from this study
SF 36 Questionnaire Validated scientific questionnaire scoring nine quality of life factors 1physical functioning 2role limitations due to physical health 3 role limitations due to emotional health 4energyfatigue 5emotional well-being 6social functioning 7pain 8 general health 9 health change
Bioelectrical Impedance Analysis BIA to assess body composition Multifrequency BIA will be performed on participants in order to determine body composition Participants will be asked to stand on a scale-like device and grasp the handles BIA works by passing multiple low energy frequencies through the hands and feet that participants will not feel This test takes about 1 minute to perform
Y-balance testing The Y Balance Test is a portion of the Functional Movement Systems screen used to evaluate dynamic balance and functional symmetry Participants will be asked to stand on one leg while reaching out in 3 different directions with the other lower extremity anterior posteromedial and posterolateral This test takes about 2-4 minutes to perform
4-minute treadmill walk test VO2 submaximal testing is a way of estimating aerobic fitness Participants will warm-up for 2 minutes at a 0 grade and a walking speed recommended speed 30-45 mph that brings their heart rate to 50-70 of herhis age-predicted max heart rate After the warmup the treadmill grade will be increased to 5 and the participant will continue to walk at the same speed for an additional 4 minutes Steady-state SS heart rate will be recorded This concludes the test and participants will cool down for 1-2 minutes
Self-selected walking speed on non-motorized treadmill On a non-motorized treadmill the movement of participants feet is what moves the treadmill belt Participants will be asked to walk on a non-motorized treadmill to determine a comfortable walking speed that can be sustained for at least 35 minutes This assessment will take about 3-4 minutes
Cognitive testing Participants will complete 8 cognitive tasks that challenge their executive function domain of cognition 4 of these tasks will be completed while standing and 4 will be completed while walking at a self-selected speed on the non-motorized treadmill Each task will take 4-6 minutes Approximate time 48 minutes
Blue Goji Gait Analysis The Blue Goji treadmill is outfitted with 4 load sensors that sample at 50 Hz Bilateral gait speed and stride variability will be collected
10 Meter Walk Test The 10 M Walk Test is a performance measure used to assess walking speed in meters per second over a short distance The test can be used to identify changes in gait speed in response to therapeutic interventions
RISKS AND DISCOMFORTS
Possible risks and discomforts participants could experience during this study include
Exercise Participants may experience exertion-related fatigue dizziness nausea muscle strain or muscle soreness
BIA There are no risks in performing the BIA test However this test will provide information about participants body composition and that could make participants feel uncomfortable
Cognitive Testing Some of the questions asked during the cognitive testing may make participants feel uneasy or embarrassed Participants may choose to skip or stop answering any questions that make participants uncomfortable
Breach of Confidentiality There is a small risk that people who are not connected with this study will learn participants identity or personal information
BENEFITS
The are no direct potential benefits to participants As part of this study a balance and body composition assessments from a trained exercise physiologist will take place Participants participation in this study will also help us learn more about potential training protocols to target cognition
PRIVACYCONFIDENTIALITY
The investigators will keep participants records for this study confidential as far as permitted by law However if investigators are required to do so by law the investigators will disclose confidential information about participants Efforts will be made to limit the use and disclosure of participants personal information including research study and medical records to people who are required to review this information The investigators may publish the information from this study in journals or present it at meetings If the investigators do participants name will not be used De-identified research will be retained for study record keeping purposes per institutional policy and future research
The University of Southern Californias Institutional Review Board IRB and Human Subjects Protections Program HSPP may review participants records
ALTERNATIVES This is not a treatment study An alternative would be to not participate in this study
COST
There are no costs related to participation VOLUNTARY PARTICIPATION
It is the participants choice whether to participate If participants choose to participate participant may change leave the study at any time If participants decide not to participate or choose to end participation in this study participants will not be penalized
WITHDRAWAL FROM STUDY INSTRUCTIONS
If participants withdraw from the study participants may be asked whether the investigator can use already collected data for analysis If participants agree this data will be handled the same as the research data No new information will be collected from participants by the study team without permission
After withdrawal the study site may still need to report any safety event that participants may have experienced due to participation to all entities involved in the study Participants personal information including any identifiable information that has already been collected up to the time of withdrawal will be kept and used to guarantee the integrity of the study to determine the safety effects and to satisfy any legal or regulatory requirements
PARTICIPANT TERMINATION
Participants may be withdrawn from the study due to injury illness personal choice or non-compliance that would prevent participants from completing all visits
Participants may be removed from this study without consent for any of the following reasons participants do not follow the study investigators instructions at the discretion of the study investigator or the sponsor participants condition gets worse or the sponsor closes the study If this happens the study investigator will discuss other options with participants
INJURY
If participants are injured as a direct result of research procedures participants will receive medical treatment however participants or the insurance of the participants will be responsible for the cost The University of Southern California does not provide any monetary compensation for injury
CONTACT INFORMATION
If participants have questions concerns complaints or think the research has hurt them talk to the study investigator Malcolm Jones at 323 442-2180 or malcoljjuscedu
This research has been reviewed by the USC Institutional Review Board IRB The IRB is a research review board that reviews and monitors research studies to protect the rights and welfare of research participants Contact the IRB if participants have questions about rights as a research participant or have complaints about the research Participants may contact the IRB at 323 442-0114 or by email at irbuscedu
STATEMENT OF CONSENT I have read or someone has read to me the information provided above I have been given a chance to ask questions All my questions have been answered By signing this form I am agreeing to take part in this study
The purpose of this study is to investigate the performance effects of manipulating the properties of a cognitively engaging aerobic task The overall goal of this proposal is to determine how changes in aspects of the task selection time number of sorting options and inclusion of different dual task walking interferences can be used to challenge the cognitive domain of executive function in a range of healthy adults The investigators hope to learn how to challenge people cognitively during exercise to promote mental benefits Participants are invited as a possible participant because are a healthy adult 40 participants will take part in the study This research is being funded by the Clinical Exercise Research Center CERC in the Division of Biokinesiology and Physical Therapy on the University of Southern California Health Sciences Campus
PROCEDURES
If participants decide to take part this is what will happen
Study Visit Participants will report to the CERC and read the informed consent with a study investigator Participants will be given the opportunity to ask any questions about the study If participants are willing to take part in the study the participant will sign this informed consent agreeing to participate Participants training intervention task will then be randomized All participants will participate in the same training but in different orders At this start of the visit the investigators will use questionnaires to determine eligibility to participate in the full study Participants will undergo the following assessments Approximate time 15 hours
Physical Activity Readiness Questionnaire PAR-Q This is a common method of uncovering health and lifestyle issues before starting an exercise program This short questionnaire will be used to reveals history of illness and if an issue is revealed it is advisable to seek doctors advice before participating in exercise excluding participants from this study
Prescreen Questionnaire Prescreening should be conducted before immersion because there are pre-existing conditions that may increase the likelihood of side effects Therefore participants will complete a brief questionnaire to identify any pre-existing conditions that would exclude participants from this study
SF 36 Questionnaire Validated scientific questionnaire scoring nine quality of life factors 1physical functioning 2role limitations due to physical health 3 role limitations due to emotional health 4energyfatigue 5emotional well-being 6social functioning 7pain 8 general health 9 health change
Bioelectrical Impedance Analysis BIA to assess body composition Multifrequency BIA will be performed on participants in order to determine body composition Participants will be asked to stand on a scale-like device and grasp the handles BIA works by passing multiple low energy frequencies through the hands and feet that participants will not feel This test takes about 1 minute to perform
Y-balance testing The Y Balance Test is a portion of the Functional Movement Systems screen used to evaluate dynamic balance and functional symmetry Participants will be asked to stand on one leg while reaching out in 3 different directions with the other lower extremity anterior posteromedial and posterolateral This test takes about 2-4 minutes to perform
4-minute treadmill walk test VO2 submaximal testing is a way of estimating aerobic fitness Participants will warm-up for 2 minutes at a 0 grade and a walking speed recommended speed 30-45 mph that brings their heart rate to 50-70 of herhis age-predicted max heart rate After the warmup the treadmill grade will be increased to 5 and the participant will continue to walk at the same speed for an additional 4 minutes Steady-state SS heart rate will be recorded This concludes the test and participants will cool down for 1-2 minutes
Self-selected walking speed on non-motorized treadmill On a non-motorized treadmill the movement of participants feet is what moves the treadmill belt Participants will be asked to walk on a non-motorized treadmill to determine a comfortable walking speed that can be sustained for at least 35 minutes This assessment will take about 3-4 minutes
Cognitive testing Participants will complete 8 cognitive tasks that challenge their executive function domain of cognition 4 of these tasks will be completed while standing and 4 will be completed while walking at a self-selected speed on the non-motorized treadmill Each task will take 4-6 minutes Approximate time 48 minutes
Blue Goji Gait Analysis The Blue Goji treadmill is outfitted with 4 load sensors that sample at 50 Hz Bilateral gait speed and stride variability will be collected
10 Meter Walk Test The 10 M Walk Test is a performance measure used to assess walking speed in meters per second over a short distance The test can be used to identify changes in gait speed in response to therapeutic interventions
RISKS AND DISCOMFORTS
Possible risks and discomforts participants could experience during this study include
Exercise Participants may experience exertion-related fatigue dizziness nausea muscle strain or muscle soreness
BIA There are no risks in performing the BIA test However this test will provide information about participants body composition and that could make participants feel uncomfortable
Cognitive Testing Some of the questions asked during the cognitive testing may make participants feel uneasy or embarrassed Participants may choose to skip or stop answering any questions that make participants uncomfortable
Breach of Confidentiality There is a small risk that people who are not connected with this study will learn participants identity or personal information
BENEFITS
The are no direct potential benefits to participants As part of this study a balance and body composition assessments from a trained exercise physiologist will take place Participants participation in this study will also help us learn more about potential training protocols to target cognition
PRIVACYCONFIDENTIALITY
The investigators will keep participants records for this study confidential as far as permitted by law However if investigators are required to do so by law the investigators will disclose confidential information about participants Efforts will be made to limit the use and disclosure of participants personal information including research study and medical records to people who are required to review this information The investigators may publish the information from this study in journals or present it at meetings If the investigators do participants name will not be used De-identified research will be retained for study record keeping purposes per institutional policy and future research
The University of Southern Californias Institutional Review Board IRB and Human Subjects Protections Program HSPP may review participants records
ALTERNATIVES This is not a treatment study An alternative would be to not participate in this study
COST
There are no costs related to participation VOLUNTARY PARTICIPATION
It is the participants choice whether to participate If participants choose to participate participant may change leave the study at any time If participants decide not to participate or choose to end participation in this study participants will not be penalized
WITHDRAWAL FROM STUDY INSTRUCTIONS
If participants withdraw from the study participants may be asked whether the investigator can use already collected data for analysis If participants agree this data will be handled the same as the research data No new information will be collected from participants by the study team without permission
After withdrawal the study site may still need to report any safety event that participants may have experienced due to participation to all entities involved in the study Participants personal information including any identifiable information that has already been collected up to the time of withdrawal will be kept and used to guarantee the integrity of the study to determine the safety effects and to satisfy any legal or regulatory requirements
PARTICIPANT TERMINATION
Participants may be withdrawn from the study due to injury illness personal choice or non-compliance that would prevent participants from completing all visits
Participants may be removed from this study without consent for any of the following reasons participants do not follow the study investigators instructions at the discretion of the study investigator or the sponsor participants condition gets worse or the sponsor closes the study If this happens the study investigator will discuss other options with participants
INJURY
If participants are injured as a direct result of research procedures participants will receive medical treatment however participants or the insurance of the participants will be responsible for the cost The University of Southern California does not provide any monetary compensation for injury
CONTACT INFORMATION
If participants have questions concerns complaints or think the research has hurt them talk to the study investigator Malcolm Jones at 323 442-2180 or malcoljjuscedu
This research has been reviewed by the USC Institutional Review Board IRB The IRB is a research review board that reviews and monitors research studies to protect the rights and welfare of research participants Contact the IRB if participants have questions about rights as a research participant or have complaints about the research Participants may contact the IRB at 323 442-0114 or by email at irbuscedu
STATEMENT OF CONSENT I have read or someone has read to me the information provided above I have been given a chance to ask questions All my questions have been answered By signing this form I am agreeing to take part in this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None