Physiological and Psychological Responses to ExerciseNCT04868136
Effects of a Warm-up on Immune Response to Exercise
A study testing Exercise in people with Physiological and Psychological Responses to Exercise, run by University of Houston at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Physiological and Psychological Responses to Exercise
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2018to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Also called Cardiorespiratory 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
| Study group | Role | What they receive |
|---|---|---|
| Warm-up, then no warm-up | Experimental | 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. Receives: Behavioral: Exercise |
| No warm-up, then warm-up | Experimental | 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. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate during exercise
Heart rate in beats per minute
Measured: Minutes 1-30 of exercise, recordings made each minute
Perceived exertion during exercise
Rating of perceived exertion measured using the Borg 6-20 scale
Measured: Minutes 1-30 of exercise, recordings made each minute
Power during exercise
Wattage produced on stationary bicycle
Measured: Minutes 1-30 of exercise, recordings made each minute
Monocyte mobilization by exercise
Number of peripheral blood monocytes
Measured: Change from resting levels of monocytes after exercise
Natural Killer cell mobilization by exercise
Number of peripheral blood natural killer cells
Measured: Change from resting levels of natural killer cells after exercise
CD4 T cell mobilization by exercise
Number of peripheral blood CD4 T cells
Measured: Change from resting levels of CD4 T cells after exercise
CD8 T cell mobilization by exercise
Number of peripheral blood CD8 T cells
Measured: Change from resting levels of CD8 T cells after exercise
Secondary outcomes (2)
Mood after exercise
Mood dimensions characterized by Profile of Mood Survey
Measured: Measured within 10 minute of end of exercise session
Affect after exercise
Affect characterized by Positive and Negative Affect Schedule
Measured: Measured within 10 minute of end of exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start15 Jul 2018
- Primary completion1 Feb 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiological and Psychological Responses to ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized cross-over study with two conditions. Randomization was stratified by sex
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emily C Lavoy, University of Houston
- Investigators
- Emily C LaVoy, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868136
- Sponsor's protocol ID
- STUDY00000990
- Status last verified
- May 2022
- First submitted
- 25 Apr 2021
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data that underlie results in a publication will be made available upon request
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Dynamic Warm up on the Immune Response to Exercise in Lower Fit and Higher Fit Adults
- ClinicalTrials.gov ID
- NCT04868136
- Acronym / sponsor ID
- STUDY00000990
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized cross-over study with two conditions. Randomization was stratified by sex
| Arm | Type | Receives |
|---|---|---|
| Warm-up, then no warm-up | Experimental | Behavioral: ExerciseParticipants' 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. |
| No warm-up, then warm-up | Experimental | Behavioral: ExerciseParticipants' 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Cardiorespiratory exercise30 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 | Behavioural | No warm-up, then warm-up, Warm-up, then no warm-up |
Primary outcome
Heart rate during exercise
Time frame: Minutes 1-30 of exercise, recordings made each minute
Heart rate in beats per 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
Power during exercise
Time frame: Minutes 1-30 of exercise, recordings made each minute
Wattage produced on stationary bicycle
Monocyte mobilization by exercise
Time frame: Change from resting levels of monocytes after exercise
Number of peripheral blood monocytes
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
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
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
2 secondary outcomes
Mood after exercise
Time frame: Measured within 10 minute of end of exercise session
Affect after exercise
Time frame: Measured within 10 minute of end of exercise session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: Yes. All individual participant data that underlie results in a publication will be made available upon request
Related trials for Physiological and Psychological Responses to Exercise
Recruiting
Consecutive Occupational Heat Exposure With and Without Overnight Cooling
Body Temperature Changes, Heat Stress
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily C LaVoy, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Physiological and Psychological Responses to Exercise, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate during exercise (time frame: Minutes 1-30 of exercise, recordings made each minute). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.