Back to resultsFatigue and Cognitive Demand With Aging
Primary Purpose
Fatigue
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cognitive task
Sponsored by
About this trial
This is an interventional other trial for Fatigue focused on measuring sex difference, aging
Eligibility Criteria
Inclusion Criteria:
- Healthy individuals aged between 18-35 and 65-90
Exclusion Criteria:
- Metal implants or joint replacement. neuromuscular disease
Sites / Locations
- University of OklahomaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
young men
young women
older men
older women
Arm Description
Individuals will participate in 1 familiarization and 3 test sessions
Individuals will participate in 1 familiarization and 3 test sessions
Individuals will participate in 1 familiarization and 3 test sessions
Individuals will participate in 1 familiarization and 3 test sessions
Outcomes
Primary Outcome Measures
force
Change in force of the arm muscles will be evaluated with a custom made device during each test session
anxiety levels
changes in anxiety levels quantified with a questionnaire
arterial pressure
changes in arterial pressure will be quantified with a non-invasive device (finometer)
fatigue
changes in fatigue will be assessed with questionnaires
Secondary Outcome Measures
Full Information
NCT ID
NCT05121272
First Posted
September 3, 2021
Last Updated
November 4, 2021
Sponsor
University of Oklahoma
1. Study Identification
Unique Protocol Identification Number
NCT05121272
Brief Title
Fatigue and Cognitive Demand With Aging
Official Title
Fatigue and Cognitive Demand With Aging
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 11, 2021 (Actual)
Primary Completion Date
October 10, 2023 (Anticipated)
Study Completion Date
October 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine the influence of a cognitive task performed during fatiguing contractions.
Detailed Description
Individuals will participate in one familiarization session followed by 3 randomized experimental sessions (crossover design).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
Keywords
sex difference, aging
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
young men
Arm Type
Experimental
Arm Description
Individuals will participate in 1 familiarization and 3 test sessions
Arm Title
young women
Arm Type
Experimental
Arm Description
Individuals will participate in 1 familiarization and 3 test sessions
Arm Title
older men
Arm Type
Experimental
Arm Description
Individuals will participate in 1 familiarization and 3 test sessions
Arm Title
older women
Arm Type
Experimental
Arm Description
Individuals will participate in 1 familiarization and 3 test sessions
Intervention Type
Behavioral
Intervention Name(s)
cognitive task
Intervention Description
cognitive task
Primary Outcome Measure Information:
Title
force
Description
Change in force of the arm muscles will be evaluated with a custom made device during each test session
Time Frame
Each session will take approximately 2-3 hours (total of 4 test sessions)
Title
anxiety levels
Description
changes in anxiety levels quantified with a questionnaire
Time Frame
Each session will take approximately 2-3 hours (total of 4 test sessions
Title
arterial pressure
Description
changes in arterial pressure will be quantified with a non-invasive device (finometer)
Time Frame
Each session will take approximately 2-3 hours (total of 4 test sessions
Title
fatigue
Description
changes in fatigue will be assessed with questionnaires
Time Frame
Each session will take approximately 2-3 hours (total of 4 test sessions
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals aged between 18-35 and 65-90
Exclusion Criteria:
Metal implants or joint replacement. neuromuscular disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hugo Pereira
Phone
4053252773
Email
hugomax@ou.edu
Facility Information:
Facility Name
University of Oklahoma
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73071
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugo Pereira, PhD
Phone
405-325-2773
Email
hugomax@ou.edu
12. IPD Sharing Statement
Learn more about this trial
Fatigue and Cognitive Demand With Aging
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