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How Exercise Signals Health Responses

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ClinicalTrials.gov Identifier: NCT04307212
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
James Roemmich, USDA Grand Forks Human Nutrition Research Center

Brief Summary:
The purpose of this research is to determine the blood signals that promote health and well-being in response to exercise at different intensities.

Condition or disease Intervention/treatment Phase
Overweight Other: 50% heart rate reserve (HRR) low intensity exercise Other: 75% HRR moderate intensity exercise Other: Control no exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: A 3-way factorial design will be employed with training status as a between-subjects variable, and exercise intensity and time as within-subjects variables. The order of exercise intensity will be counterbalanced across subjects.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exercise is Medicine. How Exercise Signals Health Responses
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


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.
Other: 50% heart rate reserve (HRR) low intensity exercise
Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)

Other: 75% HRR moderate intensity exercise
Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)

Other: Control no exercise
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.
Other: 50% heart rate reserve (HRR) low intensity exercise
Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)

Other: 75% HRR moderate intensity exercise
Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)

Other: Control no exercise
Trained and untrained participants will have a no exercise control day




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307212


Contacts
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Contact: James Roemmich, PhD 701-795-8272 james.roemmich@usda.gov
Contact: William Siders, PhD 701-795-8430 william.siders@usda.gov

Locations
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United States, North Dakota
USDA Grand Forks Human Nutrition Research Center Recruiting
Grand Forks, North Dakota, United States, 58203
Contact: Angela J Scheett, MPH, RD    701-795-8386    angela.scheett@usda.gov   
Sponsors and Collaborators
USDA Grand Forks Human Nutrition Research Center
Investigators
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Principal Investigator: James Roemmich, PhD USDA Grand Forks Human Nutrition Research Center
Additional Information:
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Responsible Party: James Roemmich, Center Director, USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT04307212    
Other Study ID Numbers: GFHNRC409
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight