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HIIT Effects on Cardiometabolic Health

Primary Purpose

Obesity, Cardiovascular Diseases, Metabolic Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high-intensity interval training intervention
Sponsored by
Syracuse University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring HIIT, Detraining effects, Cardiometabolic disease, Obesity, Young adults

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Young adults with obesity (Age 18 to 25 years old, BMI ≥ 30 kg/m2). Exclusion Criteria: Syndromic obesity; 1) Any clinical symptoms including cognitive delay, 2) abnormalities in body structure(s), 3) organ-specific abnormalities (kidney, liver failure, excessive eating, and/or other signs of hypothalamic dysfunction such as fatigue, weakness and/or lack of interest in activities. Taking weight loss medication(s) Currently enrolled (or within previous 6 months) in a weight loss program; An underlying disease/medications (steroids, second generation psychotropic agents, hormonal contraception, statins, antihypertensive and antidiabetic medications) that could influence carbohydrate or lipid metabolism. Presence of cardiac pacemaker. Current or anticipated participation in another research that would interfere with any of the outcomes. Current or anticipated pregnancy.

Sites / Locations

  • Women's BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

5s HIIT

10s HIIT

20s HIIT

Control

Arm Description

5s HIIT group will perform one bout of sprint running for 5-seconds followed by 25-second, resting of total 40 repetition.

10s HIIT group will perform one bout of sprint running for 10-seconds followed by 50-second, resting of total 20 repetition.

20s HIIT group will perform one bout of sprint running for 20-seconds followed by 100-second, resting of total 10 repetition.

Control group

Outcomes

Primary Outcome Measures

Height
Height (cm)
Weight
Weight (kg); Change from Baseline weight at 2 week and 4 week
Body mass index
Body mass index (kg/m2); Change from Baseline BMI at 2 week and 4 week
Percentage body fat
Percentage body fat (kg); Change from Baseline percentage body fat at 2 week and 4 week
Fat mass
Fat mass (kg); Change from Baseline fat mass at 2 week and 4 week
Lean mass
Lean mass (kg); Change from Baseline lean mass at 2 week and 4 week
Systolic blood pressure
Systolic blood pressure (SBP, mmHg); Change from Baseline SBP at 2 week and 4 week
Diastolic blood pressure
Diastolic blood pressure (DBP, mmHg); Change from Baseline DBP at 2 week and 4 week
Mean arterial pressure
Mean blood pressure (MAP, mmHg); Change from Baseline MAP at 2 week and 4 week
Flow-mediated dilation
Flow-mediated dilation (FMD, mm); Change from Baseline FMD at 2 week and 4 week
Carotid-femoral Pulse Wave Velocity (cPWV)
cPWV (m/s); Change from Baseline cPWV at 2 week and 4 week
Total cholesterol
Total cholesterol (mg/dl); Change from Baseline TC at 2 week and 4 week
LDL-C
LDL-C (mg/dl); Change from Baseline LDL-C at 2 week and 4 week
HDL-C
HDL-C (mg/dl); Change from Baseline HDL-C at 2 week and 4 week
Triglycerides
Triglycerides (TG, mg/dl); Change from Baseline TG at 2 week and 4 week
Glucose
Glucose (mg/dl); Change from Baseline glucose at 2 week and 4 week

Secondary Outcome Measures

Full Information

First Posted
February 13, 2023
Last Updated
April 19, 2023
Sponsor
Syracuse University
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1. Study Identification

Unique Protocol Identification Number
NCT05838950
Brief Title
HIIT Effects on Cardiometabolic Health
Official Title
Detraining Effect of Short-term HIIT on Cardiometabolic Risk in Young Adults With Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
February 10, 2024 (Anticipated)
Study Completion Date
December 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Syracuse University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary aim of this randomized clinical trial is to compare the effects of three different HIIT protocols and a control group on cardiometabolic health in young adults with obesity. Participants will be randomly assigned to one of the following three groups, with each having varying work-to-rest ratios: 1) HIIT-A, 2) HIIT-B, 3) HIIT-C, and 4) control group. HIIT-A, HIIT-B, and HIIT-C groups will participate in six sessions of a running based HIIT program over a 2-week training period. Pre-clinical markers of cardiovascular disease, blood lipids and fasting glucose will be measured at the following three time points: baseline, post-intervention, and 2 weeks after the training cessation (i.e., measure for detraining effect). All measurements will be performed three days before the training program and three days after the intervention to avoid the effect of the last training session. Afterwards, the detraining test will be measured 2 weeks post intervention.
Detailed Description
Introduction: High-intensity interval training (HIIT) compared with other traditional exercise regimens has shown to be effective in improving cardiometabolic health (as measured by lipids, blood pressure [BP], insulin sensitivity, pulse wave velocity) in overweight and obese adults. By knowing which HIIT protocol is more efficacious in improving markers of cardiometabolic disease, exercise physiologists, researchers and clinicians can properly prescribe exercise medicine to obese young adults and possibly prevent disease progression. Therefore, the primary aim of the present research is to compare the effects of 3 different HIIT protocols compared with a control group on cardiometabolic health improvement in young adults with obesity. Participants: Participants will be randomly assigned to one of the following three groups : 1) HIIT-A (5:25 s; 1:5 ratio), 2) HIIT-B (10:50 s; 1:5 ratio), 3) HIIT-C (20:100 s; 1:5 ratio), and 4) control group. HIIT-A, HIIT-B, and HIIT-C groups will participate in six sessions of running-based HIIT programs over a 2-week training period. The variables will be measured at the following three time points: baseline, post-intervention, and 2 weeks after the TC (i.e., measure for detraining effect). High-Intensity Interval Training (six sessions over 2 weeks): Heart rate will be recorded - while performing a sprint running based on the wood court. The HIIT intensity will be set at 90% of the fastest baseline with 40 repetitions of 5-seconds work time, 20 repetitions of 10-seconds work time, or 10 repetitions of 20-seconds work time. All participants will perform one bout of sprint running for 5-, 10-, or 20- seconds followed by 25-second, 50-second, or 100-seconds resting. The supervisor will verbally encourage the running to inspire the sprint at "all-out" intensity. Note that a total of 200-seconds workout time is required per session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cardiovascular Diseases, Metabolic Disease, High-intensity Interval Training
Keywords
HIIT, Detraining effects, Cardiometabolic disease, Obesity, Young adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5s HIIT
Arm Type
Experimental
Arm Description
5s HIIT group will perform one bout of sprint running for 5-seconds followed by 25-second, resting of total 40 repetition.
Arm Title
10s HIIT
Arm Type
Experimental
Arm Description
10s HIIT group will perform one bout of sprint running for 10-seconds followed by 50-second, resting of total 20 repetition.
Arm Title
20s HIIT
Arm Type
Experimental
Arm Description
20s HIIT group will perform one bout of sprint running for 20-seconds followed by 100-second, resting of total 10 repetition.
Arm Title
Control
Arm Type
Experimental
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
high-intensity interval training intervention
Intervention Description
Intervention groups include 3 arms with 3 different HIIT protocols to identify optimal exercise regimen for improving cardiometabolic health in young adults with obesity.
Primary Outcome Measure Information:
Title
Height
Description
Height (cm)
Time Frame
Baseline
Title
Weight
Description
Weight (kg); Change from Baseline weight at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Body mass index
Description
Body mass index (kg/m2); Change from Baseline BMI at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Percentage body fat
Description
Percentage body fat (kg); Change from Baseline percentage body fat at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Fat mass
Description
Fat mass (kg); Change from Baseline fat mass at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Lean mass
Description
Lean mass (kg); Change from Baseline lean mass at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Systolic blood pressure
Description
Systolic blood pressure (SBP, mmHg); Change from Baseline SBP at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Diastolic blood pressure
Description
Diastolic blood pressure (DBP, mmHg); Change from Baseline DBP at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Mean arterial pressure
Description
Mean blood pressure (MAP, mmHg); Change from Baseline MAP at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Flow-mediated dilation
Description
Flow-mediated dilation (FMD, mm); Change from Baseline FMD at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Carotid-femoral Pulse Wave Velocity (cPWV)
Description
cPWV (m/s); Change from Baseline cPWV at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Total cholesterol
Description
Total cholesterol (mg/dl); Change from Baseline TC at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
LDL-C
Description
LDL-C (mg/dl); Change from Baseline LDL-C at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
HDL-C
Description
HDL-C (mg/dl); Change from Baseline HDL-C at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Triglycerides
Description
Triglycerides (TG, mg/dl); Change from Baseline TG at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)
Title
Glucose
Description
Glucose (mg/dl); Change from Baseline glucose at 2 week and 4 week
Time Frame
Baseline, post test (2 weeks of intervention), training cessation (2 weeks of detraining)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Young adults with obesity (Age 18 to 25 years old, BMI ≥ 30 kg/m2). Exclusion Criteria: Syndromic obesity; 1) Any clinical symptoms including cognitive delay, 2) abnormalities in body structure(s), 3) organ-specific abnormalities (kidney, liver failure, excessive eating, and/or other signs of hypothalamic dysfunction such as fatigue, weakness and/or lack of interest in activities. Taking weight loss medication(s) Currently enrolled (or within previous 6 months) in a weight loss program; An underlying disease/medications (steroids, second generation psychotropic agents, hormonal contraception, statins, antihypertensive and antidiabetic medications) that could influence carbohydrate or lipid metabolism. Presence of cardiac pacemaker. Current or anticipated participation in another research that would interfere with any of the outcomes. Current or anticipated pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myong Won Seo, Ph.D
Phone
3154012723
Email
mseo04@syr.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Wonhee Cho, MS
Phone
6267270270
Email
mseo04@syr.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joon Young Kim, Ph.D
Organizational Affiliation
Syracuse University, Departments of Exercise Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women's Building
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Departments of Exercise Science
Phone
315-443-2115

12. IPD Sharing Statement

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HIIT Effects on Cardiometabolic Health

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