Stanford University
Stanford, California, 94305-2200, United States
NCT Number: NCT05513300
The purpose of this study is to compare the impact of high-intensity interval training (HIIT) versus moderate-intensity continuous training (MICT) on human health outcomes in healthy sedentary subjects, over 12 weeks of exercise training.
The investigators will compare several health parameters, such as changes in multiomics profile, cardiorespiratory fitness, muscle strength, and body composition, before and after 12-week interventions of either HIIT or MICT.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Not applicable
Stanford, California, 94305-2200, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Persons bicycling as a mode of transportation to and from work >1 day/week etc. will not be considered sedentary.
Leisure walkers are included unless they meet the heart rate, breathing, and sweating criteria noted above.
Exclusion criteria
A person may not participate in this study if any of the following applies to them:
Thyroid Stimulating Hormone (TSH) value outside of the normal range for the laboratory. Individuals with hypothyroidism may be referred to their primary care provider (PCP) for evaluation and retested; any medication change must be stable for more than 3 months prior to retesting.
Individuals with hyperthyroidism are excluded, including those with normal TSH on pharmacologic treatment.
i) Congestive heart failure, pericardial effusion, coronary artery disease, mild valvular heart disease, congenital heart disease, significant arrhythmia(at rest or with exercise), stroke, or symptomatic peripheral artery disease (self-report, screening test) ii) Positive stress induced wall motion abnormalities.
Shift workers: night shift work in the last 6 months or planning night shift work during the study period.
EXCLUSIONS FOR MEDICATION USE:
Use of any new drug in the last 3 months or dose change for any drug in the last within 3 months
Participants will be excluded if they are taking any of the medication listed below:
Anticoagulants Antiarrhythmics Antiplatelet drugs (other than aspirin <100 mg/day) Beta blockers Lipid-lowering medications Chronic use of medium- or long-acting sedatives and hypnotics (short-acting non-benzodiazepine sedative-hypnotics are allowed) Two or more drugs for depression Mood stabilizers Antiepileptic drugs Stimulants, Attention-Deficit/Hyperactivity Disorder (ADHD) drugs Anti-psychotic drugs Muscle relaxants Chronic oral steroids Burst/taper oral steroids more than once in the last 12 months B2-agonists, allowed if on stable dose at least 3 months 5-alpha reductase inhibitors Daily phosphodiesterase type 5 inhibitor use Androgenic anabolic steroids, anti-estrogens, anti-androgens Growth hormone, insulin like growth factor-I, growth hormone releasing hormone Any drugs used to treat diabetes mellitus or to lower blood glucose Any drugs used specifically to induce weight loss Any drugs used specifically to induce muscle growth/hypertrophy or augment exercise-induced muscle hypertrophy Narcotics and narcotic receptor agonists Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen more than 3 days a week Anti-malarials High-potency topical steroids Continuous use of antibiotics or other anti-infectives Monoclonal antibodies Any other medications that, in the opinion of local clinicians, would negatively impact or mitigate full participation and completion.
12 weeks of exercise training, 3 times per week, ~1h long
Time frame: Baseline; 12 weeks
Change in VO2 max after training, measured during cardiopulmonary exercise testing
Time frame: Baseline; 12 weeks
Changes in measured lipids in mg/dL including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides
Time frame: Baseline; 12 weeks
Change in mRNA-based expression measured in biospecimens after 12 weeks of training
Time frame: Baseline; 12 weeks
Change in protein measured in biospecimens after 12 weeks of training
Time frame: Baseline; 12 weeks
Change in metabolites measured in biospecimens after 12 weeks of training
Time frame: Baseline; 12 weeks
Change in lipids measured in biospecimens after 12 weeks of training
Time frame: Baseline; 12 weeks
Change in epigenome measured in biospecimens after 12 weeks of training
Time frame: Baseline; 12 weeks
Change in mRNA-based expression measured in biospecimens after acute exercise tests
Time frame: Baseline; 12 weeks
Change in protein measured in biospecimens after acute exercise tests
Time frame: Baseline; 12 weeks
Change in metabolites measured in biospecimens after acute exercise tests
Time frame: Baseline; 12 weeks
Change in lipids measured in biospecimens after acute exercise tests
Time frame: Baseline; 12 weeks
Change in epigenome measured in biospecimens after acute exercise tests
Time frame: Baseline; 12 weeks
Change in lean muscle mass in kg measured by dual-energy x-ray absorptiometry
Time frame: Baseline; 12 weeks
Change in fat mass in kg measured by dual-energy x-ray absorptiometry
Time frame: Baseline; 12 weeks
Change in leg strength measured by Biodex
Time frame: Baseline; 12 weeks
Change in hand grip strength measured by Biodex
Time frame: Baseline; 12 weeks
Change in resting heart rate measured by wearable devices
Time frame: Baseline; 12 weeks
Change in metagenome profile from stool microbiome kit
Time frame: Baseline; 12 weeks
Change in blood glucose in mg/dl profile measured with continuous glucose monitor
Time frame: Baseline; 12 weeks
Change in left ventricle mass measured by echocardiogram
Time frame: Baseline; 12 weeks
Change in LV diastolic volume measured by echocardiogram
Time frame: Baseline; 12 weeks
Change in ejection fraction measured by echocardiogram
Time frame: Baseline; 12 weeks
Change in exercise motivation level measured by motivation for physical activity (RM 4-FM) questionnaire. RM 4-FM scores four different dimensions of motivation, each on a 0-7 point composite scale, with higher scores indicating stronger motivation.
Time frame: Baseline; 12 weeks
Change in exercise self-efficacy measured by Exercise Self Efficacy questionnaire, , a 9-item scale providing a 9-28 point composite score, with higher scores indicating higher self-efficacy for exercise.
Time frame: Baseline; Week 4, 8, 12
Change in depression presence and/or severity measured by Patient Health Questionnaire-8, an 8-item scale providing a 0-24 point composite score, with higher scores indicating greater severity.
Time frame: Baseline; Week 4, 8, 12
Change in anxiety presence and/or severity measured by Generalized Anxiety Disorder-7 , a 7-item scale providing a 0-21 point composite score, with higher scores indicating greater anxiety.
Time frame: Baseline; Week 4, 8, 12
Change in perceived stress measured by Perceived Stress Scale-10, a 10-item scale providing a 0-40 point composite score, with higher scores indicating greater perceived stress.
Stanford University
Other
Physiological and Molecular Effects of High-intensity Interval Training (HIIT) vs. Moderate-intensity Continuous Training (MICT)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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