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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; week 4, 8, 12
Awards & highlights
Study Summary
This trial will compare the effects of HIIT vs MICT on health outcomes in sedentary adults over 12 weeks. Results will show changes in cardiorespiratory fitness, muscle strength, body comp. and multiomics profile.
Who is the study for?
This trial is for healthy adults over 18 who have been mostly inactive in the past year, with a BMI between >18 and <40. Participants should not be pregnant or planning pregnancy soon, nor have conditions like diabetes, abnormal bleeding, thyroid disease, severe heart issues, high blood pressure, extreme cholesterol levels, recent cancer treatment (except skin cancer), chronic infections or kidney problems. They shouldn't use certain medications or consume excessive alcohol/tobacco.Check my eligibility
What is being tested?
The study aims to compare two exercise programs: High-Intensity Interval Training (HIIT) and Moderate-Intensity Continuous Training (MICT). Over 12 weeks, participants will follow one of these routines to see which has a better effect on health outcomes such as fitness level changes, muscle strength improvements and body composition adjustments.See study design
What are the potential side effects?
While this trial involves physical activity rather than medication side effects typically associated with clinical trials may include muscle soreness fatigue increased risk of injury especially if exercises are performed incorrectly It's important that activities are done under supervision to minimize risks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; week 4, 8, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; week 4, 8, 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiopulmonary Exercise Testing
Clinical markers
Epigenome after 12-week intervention
+4 moreSecondary outcome measures
Blood Glucose
Depression
Ejection fraction
+17 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: MICT groupExperimental Treatment1 Intervention
Participants randomized in this group will be assigned to 12 weeks of moderate-intensity continuous training.
Group II: HIIT groupExperimental Treatment1 Intervention
Participants randomized in this group will be assigned to 12 weeks high intensity interval training.
Group III: Control groupActive Control1 Intervention
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,215 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have diabetes.I have had fainting spells that doctors can't explain.I have long-term kidney problems.I have a bone condition affecting my metabolism.I have a mental condition that affects my thinking or decision-making.I have a long-term infection.I have COPD or pulmonary hypertension.I have not donated blood in the last 3 months and do not plan to donate soon.I am currently taking blood thinners.I am not taking medication for irregular heartbeat.I use strong prescription creams for my skin condition.I am on a continuous course of antibiotics or anti-infectives.I am receiving monoclonal antibody treatment.I have been treated for cancer in the past.I have an inflammatory condition.I am currently taking estrogen or progestin medications.I am currently receiving treatment for an autoimmune disorder.I have not been hospitalized for a psychiatric condition in the past year.I have a heart condition.I haven't started any new drugs or changed doses in the last 3 months.I am not taking any medication specifically for weight loss.I am not on medications that would interfere with the trial.I am taking medication for epilepsy.I am taking medication to stabilize my mood.I am taking long-term oral steroids.I use B2-agonists for my condition.I am taking medication to prevent blood clots.I regularly use sleep or anxiety medication that works for many hours.I am currently taking medication for ADHD.I am not currently using steroids, anti-estrogens, or anti-androgens.I have not used drugs to increase muscle size or enhance workout results.I am currently using pain medication that acts on the opioid receptors.I have abnormal bleeding or a blood clotting disorder.I am taking two or more medications for depression.I am currently taking muscle relaxants.I am not taking any anti-psychotic medications.I am taking medication for diabetes or to lower my blood sugar.I have a thyroid condition.I have a muscle, bone, or nerve condition from injury, amputation, or birth.I am currently taking anti-malarial medication.I am taking medication to lower my cholesterol.I am currently taking beta blockers.I take medication for erectile dysfunction daily.I am between 18 and 55 years old.My treatment involves growth hormone or related factors.I regularly take NSAIDs or acetaminophen more than 3 days a week.I've taken short courses of oral steroids more than once in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: HIIT group
- Group 2: MICT group
- Group 3: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are persons aged 35 and over being accepted into this clinical experiment?
"This clinical trial is seeking out individuals that are above the age of consent and below 99 years old."
Answered by AI
Does this research program have any current openings for participants?
"According to clinicaltrials.gov, this experiment is still open for participants. It was initially made available on the 10th of January 2023 and has since been updated on the 5th of June 2023."
Answered by AI
How many participants are currently being admitted to this medical experiment?
"Affirmative. According to the details available on clinicaltrials.gov, this medical trial is open for enrollment. It was originally posted on 10th January 2023 and most recently amended on 5th June 2023; it seeks 150 individuals across a single location."
Answered by AI
What are the core goals of this experiment?
"The primary assessment of this research project, over a period spanning from the baseline stage to 12 weeks in total, will be based on clinical markers. Secondary measures involve an examination of mRNA-based expression after acute exercise tests for transcriptome evaluation; protein levels as part of proteome analysis; and metabolites captured by metabolomics profiling."
Answered by AI
Who would meet the eligibility criteria for participation in this experiment?
"Selected participants of this medical study must lead a healthy lifestyle and be between 18-99 years old. Approximately 150 individuals will be accepted into the trial."
Answered by AI
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