Effects of a Warm-up on Immune Response to Exercise

May 16, 2022 updated by: Emily C Lavoy, University of Houston

The Effects of a Dynamic Warm up on the Immune Response to Exercise in Lower Fit and Higher Fit Adults

This randomized cross-over study compares two identical cardiorespiratory exercise bouts, differing only in the inclusion or exclusion of a dynamic period of increasing exercise intensity prior to the exercise bout. Planned comparisons include physiological responses and perceived effort during exercise, leukocyte mobilization, and mood between the two exercise sessions.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • University of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Exercise
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:
  • Cardiorespiratory exercise
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.
Behavioral: Exercise
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:
  • Cardiorespiratory exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Minutes 1-30 of exercise, recordings made each minute
Perceived exertion during exercise
Time Frame: Minutes 1-30 of exercise, recordings made each minute
Rating of perceived exertion measured using the Borg 6-20 scale
Minutes 1-30 of exercise, recordings made each minute
Power during exercise
Time Frame: Minutes 1-30 of exercise, recordings made each minute
Wattage produced on stationary bicycle
Minutes 1-30 of exercise, recordings made each minute
Monocyte mobilization by exercise
Time Frame: Change from resting levels of monocytes after exercise
Number of peripheral blood monocytes
Change from resting levels of monocytes after exercise
Natural Killer cell mobilization by exercise
Time Frame: Change from resting levels of natural killer cells after exercise
Number of peripheral blood natural killer cells
Change from resting levels of natural killer cells after exercise
CD4 T cell mobilization by exercise
Time Frame: Change from resting levels of CD4 T cells after exercise
Number of peripheral blood CD4 T cells
Change from resting levels of CD4 T cells after exercise
CD8 T cell mobilization by exercise
Time Frame: Change from resting levels of CD8 T cells after exercise
Number of peripheral blood CD8 T cells
Change from resting levels of CD8 T cells after exercise

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mood after exercise
Time Frame: Measured within 10 minute of end of exercise session
Mood dimensions characterized by Profile of Mood Survey
Measured within 10 minute of end of exercise session
Affect after exercise
Time Frame: Measured within 10 minute of end of exercise session
Affect characterized by Positive and Negative Affect Schedule
Measured within 10 minute of end of exercise session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emily C LaVoy, PhD, University of Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 30, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00000990

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All individual participant data that underlie results in a publication will be made available upon request

IPD Sharing Time Frame

Will be available upon publication

IPD Sharing Access Criteria

Requests should be sent to and will be reviewed by the principle investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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