- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03794050
Comparing Acute Aerobic and Resistance Exercise (CAARE)
March 22, 2023 updated by: Melissa M Markofski, University of Houston
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
35
Phase
- 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
-
-
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
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- "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.
Exclusion Criteria:
- 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)
- 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
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: resistance training exercise
All participants complete one session of resistance training exercise
|
randomized complete crossover for acute resistance training exercise session
|
Experimental: aerobic training exercise
All participants complete one session of aerobic training exercise
|
randomized complete crossover for acute aerobic exercise training exercise session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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
Time Frame: compare pre-RT to pre-AT
|
Flow cytometry to classify monocyte subsets and in vitro LPS stimulation to assess monocyte function
|
compare pre-RT to pre-AT
|
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
|
compare immediately post-RT to immediately post-AT
|
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
|
compare 1hr post-RT to 1hr post-AT
|
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
|
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
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
|
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
Time Frame: compare pre-RT to pre-AT
|
Flow cytometry to identify NK cells and in vitro activity to assess NK activity
|
compare pre-RT to pre-AT
|
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
|
compare immediately post-RT to immediately post-AT
|
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
|
compare 1hr post-RT to 1hr post-AT
|
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
|
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
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
|
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
Time Frame: compare pre-RT to pre-AT
|
Flow cytometry to identify T cell subsets
|
compare pre-RT to pre-AT
|
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
|
compare immediately post-RT to immediately post-AT
|
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
|
compare 1hr post-RT to 1hr post-AT
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
ELISA to measure circulating cortisol (serum)
|
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
|
ELISA to measure circulating cortisol (serum)
|
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
|
ELISA to measure circulating cortisol (serum)
|
compare pre-RT to pre-AT
|
Serum cortisol
Time Frame: compare immediately post-RT to immediately post-AT
|
ELISA to measure circulating cortisol (serum)
|
compare immediately post-RT to immediately post-AT
|
Serum cortisol
Time Frame: compare 1hr post-RT to 1hr post-AT
|
ELISA to measure circulating cortisol (serum)
|
compare 1hr post-RT to 1hr post-AT
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melissa Markofski, PhD, University of Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
December 18, 2018
Primary Completion (Actual)
March 31, 2020
Study Completion (Actual)
March 31, 2020
Study Registration Dates
First Submitted
December 17, 2018
First Submitted That Met QC Criteria
January 2, 2019
First Posted (Actual)
January 4, 2019
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00001191
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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
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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