- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04307212
How Exercise Signals Health Responses
September 24, 2023 updated by: James Roemmich, USDA Grand Forks Human Nutrition Research Center
Exercise is Medicine. How Exercise Signals Health Responses
The purpose of this research is to determine the blood signals that promote health and well-being in response to exercise at different intensities.
Study Overview
Status
Completed
Conditions
Detailed Description
Most studies find a dose-response relationship between exercise participation and all-cause mortality.
In contrast, physical inactivity and consequent overweight or obese status is associated with a cadre of health consequences.
Frequently, comorbidities of obesity are mechanistically linked via chronic low grade inflammation stemming from increases in adiposity.
Although exercise is known to combat obesity and obesity related disease states, the mechanisms of action are not fully understood.
Therefore, the investigators propose the following study in an attempt to elucidate anti- and pro-inflammatory endocrine responses to exercise.
Initial studies in animal models have provided evidence that exercise induces long-term anti-inflammatory effects, potentially via myokine signaling following skeletal muscle activation.
Humans are an ideal study population as the investigators can prescribe multiple exercise protocols that mimic human behavior, and control exercise intensity to meet recommendations.
Also, humans allow the investigators to collect larger plasma samples and therefore measure more circulating proteins of interest over multiple time-points.
Finally, the investigators can select individuals that exercise at different frequencies, allowing the investigators to analyze the differences in endocrine responses to exercise over differing levels of fitness.
In summary, a human model will allow for a much better understanding of the human condition.
Study Type
Interventional
Enrollment (Actual)
41
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
-
-
North Dakota
-
Grand Forks, North Dakota, United States, 58203
- USDA Grand Forks Human Nutrition Research Center
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- No tobacco use
- Not pregnant, lactating, or planning to become pregnant in the next 6 months
- Regular menses for the past 6 months
- No use of hormone replacement for metabolic conditions (use of hormonal contraceptives are not exclusionary)
- No physical limitations
- Has the ability to safely perform exercise
Exclusion Criteria:
- Has no major health problems
- Cannot have known cardiovascular (cardiac, peripheral vascular, cerebrovascular), pulmonary (COPD, interstitial lung disease, cystic fibrosis) or metabolic (diabetes, thyroid disorders, renal or liver disease) disease
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: Other
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Trained
Participants who have been CrossFit training at least 3 times per week for the previous 3 months.
These individuals will be invited in person to participate in the study.
|
Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)
Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)
Trained and untrained participants will have a no exercise control day
|
Active Comparator: Untrained
Nonactive/non--exercise trained participants who have participated in any type of exercise no more than 2 times per week for the past 3 months.
These individuals will be recruited from the general public.
|
Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)
Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)
Trained and untrained participants will have a no exercise control day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma myokine concentration
Time Frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
|
Blood samples collected during exercise will be analyzed for the concentration of plasma myokines including Brain Derived Neurotropic Factor (BDNF), Secreted Protein Acidic and Rich in Cysteine (SPARC), Leukemia Inhibitory Factor (LIF), Interleukin (IL) 15, IL-6, Myostatin, Irisin, Follistatin-like 1 (FSTL-1), Fibroblast Growth Factor 21 (FGF-21), IL-4, IL-7 receptor agonist (ra), IL-7, beta-aminoisobutyric acid (BAIBA), IL-1ra, Growth Differentiation Factor (GDF) 8, Insulin-Like Growth Factor-1 (IGF1).
|
Pre-exercise, 0, 30, 60, 90 minutes post-exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in plasma adipokine concentration
Time Frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
|
Blood samples collected during exercise will be analyzed for the concentration of plasma adipokines including myonectin.
|
Pre-exercise, 0, 30, 60, 90 minutes post-exercise
|
Change in plasma cytokine concentration
Time Frame: Pre-exercise, 0, 30, 60, 90 minutes post-exercise
|
Blood samples collected during exercise will be analyzed for the concentration of plasma cytokines including IL-8, Tumor necrosis factor alpha (TNFα), C-reactive protein (CRP), fibrinogen, and IGF1.
|
Pre-exercise, 0, 30, 60, 90 minutes post-exercise
|
Relative reinforcing value (RRV) of exercise
Time Frame: Week 0
|
RRV of exercise will be assessed by evaluating the number of responses (mouse button presses) a participant is willing to complete to gain access to exercise or an alternative (magazines, word games, puzzles).
|
Week 0
|
Minutes of physical activity, as assessed by activity tracker
Time Frame: Week 0
|
Minutes of physical activity will be assessed by having participants wear an Actigraph accelerometer for 7 days (minimum 10 hours per day) on the right hip.
|
Week 0
|
Usual modes of sedentary behavior
Time Frame: Week 0
|
Usual modes of sedentary behavior will be determined via the validated International Physical Activity Questionnaire (IPAQ).
The IPAQ measures habitual physical activity for the past 7 days and consists of four domains of physical activity: job-related (7 items), transportation (6 items), household/gardening (6 items), and leisure-time activities (6 items).
To show sedentary behavior, two questions regarding time spent sitting are also included.
The number of minutes for each activity class is multiplied by the MET score for that activity to convert the IPAQ data into metabolic equivalent scores (MET-min-week-1).
Physical activity levels are then classified as being inactive, minimally active, and health-enhancing physically active.
|
Week 0
|
Preference for intense physical activity and tolerance for exercise discomfort
Time Frame: Week 0
|
Preference for intense physical activity and tolerance for exercise discomfort will be assessed by self-report questionnaire responses to the Preference for and Tolerance of the Intensity of Exercise Questionnaire (PRETIE-Q).
The PRETIE-Q measures preference for high intensity vs. low intensity exercise and ability to persist or tolerate the discomfort associated with intense exercise.
The PRETIE-Q consists of two subscales: Preference for Exercise Intensity and Tolerance of Exercise Intensity.
Each subscale has 8 items rated on a 5-point response scale (range 8 - 40).
Higher scores indicate greater preference for intense exercise and/or greater tolerance for exercise discomfort.
Total scale scores are not used.
Scale averages will be used.
|
Week 0
|
Fat mass as assessed by dual energy x-ray absorptiometry (DXA) scans
Time Frame: Week 0
|
Participants will be instructed to lie supine with hands by their sides on a GE Lunar iDXA machine for a full-body x-ray scan which will measure grams and percentage changed in fat mass.
|
Week 0
|
Fat-free lean mass as assessed by DXA scans
Time Frame: Week 0
|
Participants will be instructed to lie supine with hands by their sides on a GE Lunar iDXA machine for a full-body x-ray scan which will measure grams and percentage changed in fat-free lean mass.
|
Week 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: James Roemmich, PhD, USDA Grand Forks Human Nutrition Research Center
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)
January 10, 2020
Primary Completion (Actual)
September 12, 2023
Study Completion (Actual)
September 12, 2023
Study Registration Dates
First Submitted
February 27, 2020
First Submitted That Met QC Criteria
March 10, 2020
First Posted (Actual)
March 13, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 24, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GFHNRC409
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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