HIIT vs. MICT Training Study

NCT05513300 | Active Not Recruiting

• 1 other identifier: 64208
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lifestyle; Sedentary

Outcome Measures

Primary Outcomes (7)

• Cardiopulmonary Exercise Testing

  Change in VO2 max after training, measured during cardiopulmonary exercise testing

  Baseline; 12 weeks

• Clinical markers

  Changes in measured lipids in mg/dL including total cholesterol, LDL cholesterol, HDL cholesterol, and triglycerides

  Baseline; 12 weeks

• Transcriptome after 12-week intervention

  Change in mRNA-based expression measured in biospecimens after 12 weeks of training

  Baseline; 12 weeks

• Proteome after 12-week intervention

  Change in protein measured in biospecimens after 12 weeks of training

  Baseline; 12 weeks

• Metabolome after 12-week intervention

  Change in metabolites measured in biospecimens after 12 weeks of training

  Baseline; 12 weeks

• Lipidome after 12-week intervention

  Change in lipids measured in biospecimens after 12 weeks of training

  Baseline; 12 weeks

• Epigenome after 12-week intervention

  Change in epigenome measured in biospecimens after 12 weeks of training

  Baseline; 12 weeks

Secondary Outcomes (20)

• Transcriptome after acute exercise

  Baseline; 12 weeks

• Proteome after acute exercise

  Baseline; 12 weeks

• Metabolome after acute exercise

  Baseline; 12 weeks

• Lipidome after acute exercise

  Baseline; 12 weeks

• Epigenome after acute exercise

  Baseline; 12 weeks

Study Arms (3)

HIIT group

EXPERIMENTAL

Participants randomized in this group will be assigned to 12 weeks high intensity interval training.

Other: Exercise intervention

MICT group

EXPERIMENTAL

Participants randomized in this group will be assigned to 12 weeks of moderate-intensity continuous training.

Other: Exercise intervention

Control group

NO INTERVENTION

Interventions

Exercise intervention OTHER

12 weeks of exercise training, 3 times per week, \~1h long

HIIT group; MICT group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be 18-65 years of age
• Not be pregnant or lactating in the last 12 months, or planning to become pregnant for the next 4 months. A pregnancy test will be performed on the day of DXA scan in women of child-bearing potential. Not be post-partum during the last 12 months.
• Be generally healthy (a list of medical conditions and/or medication that will exclude participants is listed in the section below)
• Body mass index (BMI) \> 18 to \< 40 kg/m2
• Sedentary in the past year, defined as regular (structured) endurance exercise (e.g., brisk walking, jogging, running, cycling, elliptical, or swimming activity that results in feelings of increased heart rate, rapid breathing, and/or sweating) or resistance training (resulting in muscular fatigue), no more than 1 hour per week.
• 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.

You may not qualify if:

• A person may not participate in this study if any of the following applies to them:
• Diabetes (self-report and screening tests), which includes: i) treatment with any hypoglycemic agents (self-report, even for non-diabetic reasons) or ii) fasting glucose \>125 or A1c \>6.4 (screening test).
• Abnormal bleeding or coagulopathy (self-report): history of a bleeding disorder or clotting abnormality.
• Thyroid disease (screening test):
• 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.
• Clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) and/or pulmonary hypertension.
• Metabolic bone disease (self-report): i) history of non-traumatic fracture from a standing height or less and/or ii) current pharmacologic treatment for low bone mass or osteoporosis, other than calcium, vitamin D, or estrogen.
• Estrogens, progestins (self-report): supplemental, replacement or therapeutic use of estrogens or progestins within the last 6 months, other than birth control or to control menopausal symptoms.
• Elevated blood pressure readings (screening test): i) age \< 60 years: any history of hypertension; ii) age \> 60 years: resting blood pressure reading higher than 150/90 mmHg.
• Cardiovascular diseases (self-report, screening tests, and clinician judgment):
• 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.
• Unexplained syncope.
• Abnormal blood lipid profile (screening test): either fasting triglycerides \>500 mg/dLand/or LDL cholesterol (LDL-C) \>190mg/dL.
• History of cancer treatment (other than non-melanoma skin cancer) and not "cancer-free" for at least 2 years. Anti-hormonal therapy (e.g., for breast or prostate cancer) within the last 6 months.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305-2200, United States

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: August 24, 2022
• Study Start: January 10, 2023
• Primary Completion: August 11, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)