- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04868136
Effects of a Warm-up on Immune Response to Exercise
The Effects of a Dynamic Warm up on the Immune Response to Exercise in Lower Fit and Higher Fit Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
Physically active adult men and women are asked to complete three study visits to the laboratory. On Visit 1, participants provide informed consent and are screened for study inclusion criteria: being between 18 and 40 years of age, a non-smoker, not pregnant, free of disease impacting exercise performance or immunity, and performing at least one hour per week of vigorous exercise training (any modality) for at least the prior six months. Participants also complete an incremental submaximal exercise test on a stationary bicycle. The results of this test are used to calculate the resistance corresponding to 80% of estimated maximal heart rate. Participants return within 2-14 days for Visits 2 and 3. These visits consist of 30 min of bicycling at this resistance. One visit included a 10 min dynamic warm-up prior to the exercise bout. Participants were stratified by sex and randomized such that half of the men and women completed the exercise trial with warm-up during Visit 2.
Heart rate, perceived exertion, and wattage are recorded during each minute of the exercise bouts. Participants donate blood before, immediately after, and 1h after each exercise. Blood is analyzed by flow cytometry to characterize leukocyte subsets. After each exercise session, participants complete surveys assessing mood and affect.
Physiological, immunological, and psychological parameters recorded will be compared within participants between the two experimental exercise sessions using appropriate statistical tests. p<0.05 will be accepted as significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77204
- University of Houston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- identifies as exercising 1-3 hours per week or more than 6 hours per week, on average (last 6 months)
- meets American College of Sports Medicine criteria for participation in exercise
Exclusion Criteria:
- underlying medical problems that contraindicate supervised high intensity exercise
- past or present history of autoimmune disease, HIV, hepatitis, stroke, or cardiovascular disease
- chronic/debilitating arthritis
- central or peripheral nervous disorders
- asthma, emphysema, or bronchitis
- bedridden in the past three months
- history of blood clotting disorders
- administration of any medication that might affect physiological response to exercise
- functional or cognitive impairment that would limit exercise performance or prohibit informed consent
- having any common-cold or influenza like symptoms (scratchy throat, runny nose, inflamed sinuses, frequent sneezing or coughing) in the last 2 weeks
- pregnancy
- tobacco use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Warm-up, then no warm-up
Participants' visit 2 included 10 minutes of gradually increasing intensity prior to the 30 minute exercise session.
Participants' visit 3 consisted of the 30 minute exercise session without a warm-up.
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30 minutes of exercise at 80% of maximum predicted heart rate performed on an indoor stationary bicycle.
Exercise was preceded by 10 min of gradually increasing cycling intensity in one of two exercise trials
Other Names:
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Experimental: No warm-up, then warm-up
Participants' visit 2 consisted of the 30 minute exercise session without a warm-up.
Participants' visit 3 included 10 minutes of gradually increasing intensity prior to the 30 minute exercise session.
|
30 minutes of exercise at 80% of maximum predicted heart rate performed on an indoor stationary bicycle.
Exercise was preceded by 10 min of gradually increasing cycling intensity in one of two exercise trials
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate during exercise
Time Frame: Minutes 1-30 of exercise, recordings made each minute
|
Heart rate in beats per minute
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Minutes 1-30 of exercise, recordings made each minute
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Perceived exertion during exercise
Time Frame: Minutes 1-30 of exercise, recordings made each minute
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Rating of perceived exertion measured using the Borg 6-20 scale
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Minutes 1-30 of exercise, recordings made each minute
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Power during exercise
Time Frame: Minutes 1-30 of exercise, recordings made each minute
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Wattage produced on stationary bicycle
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Minutes 1-30 of exercise, recordings made each minute
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Monocyte mobilization by exercise
Time Frame: Change from resting levels of monocytes after exercise
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Number of peripheral blood monocytes
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Change from resting levels of monocytes after exercise
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Natural Killer cell mobilization by exercise
Time Frame: Change from resting levels of natural killer cells after exercise
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Number of peripheral blood natural killer cells
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Change from resting levels of natural killer cells after exercise
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CD4 T cell mobilization by exercise
Time Frame: Change from resting levels of CD4 T cells after exercise
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Number of peripheral blood CD4 T cells
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Change from resting levels of CD4 T cells after exercise
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CD8 T cell mobilization by exercise
Time Frame: Change from resting levels of CD8 T cells after exercise
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Number of peripheral blood CD8 T cells
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Change from resting levels of CD8 T cells after exercise
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mood after exercise
Time Frame: Measured within 10 minute of end of exercise session
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Mood dimensions characterized by Profile of Mood Survey
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Measured within 10 minute of end of exercise session
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Affect after exercise
Time Frame: Measured within 10 minute of end of exercise session
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Affect characterized by Positive and Negative Affect Schedule
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Measured within 10 minute of end of exercise session
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emily C LaVoy, PhD, University of Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00000990
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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