Exercise PhysiologyCAARENCT03794050
Comparing Acute Aerobic and Resistance Exercise
A study testing Resistance training exercise and Aerobic training exercise in people with Exercise Physiology, run by University of Houston at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of age and fitness level on the physiological response to an acute bout of resistance or aerobic exercise. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Physiology
- What is being tested?
- Resistance training exercise and Aerobic training exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2018to 31 Mar 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- "Young" Adults: ages 18-30
- "Older" Adults: ages 55-75 and if a female postmenopausal
- Participants classified as "trained" must participate in at least 30 minutes of moderate to vigorous intensity cardiovascular activity at least 3 days per week and engage in resistance training for all of the major muscle groups approximately 2 days / week. They must have upheld this activity for the past 3 months
- Participants classified as "untrained" must be participating in less than 30 minutes of moderate to vigorous intensity cardiovascular activity and less than 2 days of resistance training per week for at least the last 3 months.
Who cannot join
- Have any contraindications to moderate to vigorous exercise
- Range of motion restrictions that would prevent them from participating in aerobic or resistance training with proper form (they must be ambulatory)
- aking medications (prescription or over the counter) known to influence immune function, including daily NSAID's, beta blockers, statins, bisphosphonates, or steroids.
- Have known cardiovascular, respiratory, metabolic, or renal disease, with the exception of controlled hypertension (as defined by resting BP below 140/90) and/or controlled asthma (self-reported).
- Be pregnant
- Be unable to complete all visits (i.e. must not be planning to leave the Houston area long-term before concluding their participation in the study which will span several weeks)
Show all 11Show fewer
- Fall outside of a BMI range of (18.5 - 30)
- Consume alcohol or recreational drugs for 24h prior to visits
- Older women cannot be pre-menopausal (must have not had a menses for at least 12 months)
- Unable to speak or read English
- Participants must not have scheduling conflicts that would prevent them from reporting to the laboratory of integrated physiology 4 times over the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Age, Fitness Level, and Modality on Physiological Response to Acute Exercise
The purpose of this study is to determine the effect of age and fitness level on the physiological response to an acute bout of resistance or aerobic exercise.
Read the detailed description
Young and middle-aged to older adults who are physically active or not physically active will participate in two moderate to vigorous intensity exercise bouts: aerobic exercise and resistance training exercise. Blood will be collected to assess immune function and metabolism.
- Conditions
- Exercise Physiology
- Being tested
- Resistance training exercise, Aerobic training exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance training exerciseOther
randomized complete crossover for acute resistance training exercise session
Aerobic training exerciseOther
randomized complete crossover for acute aerobic exercise training exercise session
| Study group | Role | What they receive |
|---|---|---|
| resistance training exercise | Experimental | All participants complete one session of resistance training exercise Receives: Other: Resistance training exercise |
| aerobic training exercise | Experimental | All participants complete one session of aerobic training exercise Receives: Other: Aerobic training exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocyte subset and function
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Measured: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
Monocyte subset and function
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Measured: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
Monocyte subset and function
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Measured: compare pre-RT to pre-AT
Monocyte subset and function
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Measured: compare immediately post-RT to immediately post-AT
Monocyte subset and function
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Measured: compare 1hr post-RT to 1hr post-AT
NK cell function
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
Measured: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
NK cell function
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
Measured: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
NK cell function
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
Measured: compare pre-RT to pre-AT
NK cell function
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
Measured: compare immediately post-RT to immediately post-AT
NK cell function
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
Measured: compare 1hr post-RT to 1hr post-AT
Circulating relative and absolute counts of T cell subsets
Flow cytometry to identify T cell subsets
Measured: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
Circulating relative and absolute counts of T cell subsets
Flow cytometry to identify T cell subsets
Measured: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
Circulating relative and absolute counts of T cell subsets
Flow cytometry to identify T cell subsets
Measured: compare pre-RT to pre-AT
Circulating relative and absolute counts of T cell subsets
Flow cytometry to identify T cell subsets
Measured: compare immediately post-RT to immediately post-AT
Circulating relative and absolute counts of T cell subsets
Flow cytometry to identify T cell subsets
Measured: compare 1hr post-RT to 1hr post-AT
Secondary outcomes (5)
Serum cortisol
ELISA to measure circulating cortisol (serum)
Measured: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
Serum cortisol
ELISA to measure circulating cortisol (serum)
Measured: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
Serum cortisol
ELISA to measure circulating cortisol (serum)
Measured: compare pre-RT to pre-AT
Serum cortisol
ELISA to measure circulating cortisol (serum)
Measured: compare immediately post-RT to immediately post-AT
Serum cortisol
ELISA to measure circulating cortisol (serum)
Measured: compare 1hr post-RT to 1hr post-AT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start18 Dec 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Why it stopped: Due to SARS-CoV-2 pandemic research restrictions placed by university, we were unable to complete enrollment of all participants in a timely manner. Data analyses and publications will occur with the participants who did complete the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise PhysiologyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa M Markofski, University of Houston
- Investigators
- Melissa Markofski, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794050
- Sponsor's protocol ID
- STUDY00001191
- Acronym
- CAARE
- Status last verified
- Mar 2023
- First submitted
- 17 Dec 2018
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are considering making available IDP to others upon request, but would have to get an IRB change because that is not in our protocol
Publications
Graff RM, Jennings K, LaVoy ECP, Warren VE, Macdonald BW, Park Y, Markofski MM. T-cell counts in response to acute cardiorespiratory or resistance exercise in physically active or physically inactive older adults: a randomized crossover study. J Appl Physiol (1985). 2022 Jul 1;133(1):119-129. doi: 10.1152/japplphysiol.00301.2021. Epub 2022 May 26.
PubMed 35616304
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Age, Fitness Level, and Modality on Physiological Response to Acute Exercise
- ClinicalTrials.gov ID
- NCT03794050
- Acronym / sponsor ID
- CAARE / STUDY00001191
- Conditions
- Exercise Physiology
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to SARS-CoV-2 pandemic research restrictions placed by university, we were unable to complete enrollment of all participants in a timely manner. Data analyses and publications will occur with the participants who did complete the study.
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 4 Jan 2019 (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.
The purpose of this study is to determine the effect of age and fitness level on the physiological response to an acute bout of resistance or aerobic exercise.
Detailed description
Young and middle-aged to older adults who are physically active or not physically active will participate in two moderate to vigorous intensity exercise bouts: aerobic exercise and resistance training exercise. Blood will be collected to assess immune function and metabolism.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistance training exercise | Experimental | Other: Resistance training exerciseAll participants complete one session of resistance training exercise |
| aerobic training exercise | Experimental | Other: Aerobic training exerciseAll participants complete one session of aerobic training exercise |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- "Young" Adults: ages 18-30
- "Older" Adults: ages 55-75 and if a female postmenopausal
- Participants classified as "trained" must participate in at least 30 minutes of moderate to vigorous intensity cardiovascular activity at least 3 days per week and engage in resistance training for all of the major muscle groups approximately 2 days / week. They must have upheld this activity for the past 3 months
- Participants classified as "untrained" must be participating in less than 30 minutes of moderate to vigorous intensity cardiovascular activity and less than 2 days of resistance training per week for at least the last 3 months.
Key exclusion criteria (11 listed)
- Have any contraindications to moderate to vigorous exercise
- Range of motion restrictions that would prevent them from participating in aerobic or resistance training with proper form (they must be ambulatory)
- aking medications (prescription or over the counter) known to influence immune function, including daily NSAID's, beta blockers, statins, bisphosphonates, or steroids.
- Have known cardiovascular, respiratory, metabolic, or renal disease, with the exception of controlled hypertension (as defined by resting BP below 140/90) and/or controlled asthma (self-reported).
- Be pregnant
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 |
|---|---|---|
| Resistance training exerciserandomized complete crossover for acute resistance training exercise session | Other | resistance training exercise |
| Aerobic training exerciserandomized complete crossover for acute aerobic exercise training exercise session | Other | aerobic training exercise |
Primary outcome
Monocyte subset and function
Time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Monocyte subset and function
Time frame: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Monocyte subset and function
Time frame: compare pre-RT to pre-AT
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Monocyte subset and function
Time frame: compare immediately post-RT to immediately post-AT
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
Monocyte subset and function
Time frame: compare 1hr post-RT to 1hr post-AT
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
NK cell function
Time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
NK cell function
Time frame: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
NK cell function
Time frame: compare pre-RT to pre-AT
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
NK cell function
Time frame: compare immediately post-RT to immediately post-AT
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
NK cell function
Time frame: compare 1hr post-RT to 1hr post-AT
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
Circulating relative and absolute counts of T cell subsets
Time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
Flow cytometry to identify T cell subsets
Circulating relative and absolute counts of T cell subsets
Time frame: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
Flow cytometry to identify T cell subsets
Circulating relative and absolute counts of T cell subsets
Time frame: compare pre-RT to pre-AT
Flow cytometry to identify T cell subsets
Circulating relative and absolute counts of T cell subsets
Time frame: compare immediately post-RT to immediately post-AT
Flow cytometry to identify T cell subsets
Circulating relative and absolute counts of T cell subsets
Time frame: compare 1hr post-RT to 1hr post-AT
Flow cytometry to identify T cell subsets
5 secondary outcomes
Serum cortisol
Time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise
Serum cortisol
Time frame: Pre-aerobic training (AT) exercise, change from pre-AT exercise to immediately post-AT exercise, change from pre-AT exercise to 1hr post-AT exercise, change from immediately post-AT exercise to 1hr post-AT exercise
Serum cortisol
Time frame: compare pre-RT to pre-AT
Serum cortisol
Time frame: compare immediately post-RT to immediately post-AT
Serum cortisol
Time frame: compare 1hr post-RT to 1hr post-AT
Results and safety
The study was stopped early (reason given: Due to SARS-CoV-2 pandemic research restrictions placed by university, we were unable to complete enrollment of all participants in a timely manner. Data analyses and publications will occur with the participants who did complete the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 35616304Graff RM, Jennings K, LaVoy ECP, Warren VE, Macdonald BW, Park Y, Markofski MM. T-cell counts in response to acute cardiorespiratory or resistance exercise in physically active or physically inactive older adults: a randomized crossover study. J Appl Physiol (1985). 2022 Jul 1;133(1):119-129. doi: 10.1152/japplphysiol.00301.2021. Epub 2022 May 26.
- Individual participant dataSharing planned: Undecided. We are considering making available IDP to others upon request, but would have to get an IRB change because that is not in our protocol
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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.
Melissa Markofski, 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 Resistance training exercise and Aerobic training exercise in people with Exercise Physiology, 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 24 Mar 2023. 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 was stopped early (reason given: Due to SARS-CoV-2 pandemic research restrictions placed by university, we were unable to complete enrollment of all participants in a timely manner. Data analyses and publications will occur with the participants who did complete the study.). Results are not available in the source record.
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?
Monocyte subset and function (time frame: Pre-resistance training (RT) exercise, change from pre-RT exercise to immediately post-RT exercise, change from pre-RT exercise to 1hr post-RT exercise, change from immediately post-RT exercise to 1hr post-RT exercise). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03794050, which also lists 1 linked publication.
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 24 Mar 2023.