- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03904810
Low-frequency High-Intensity Interval Training in Overweight or Obese Young Adults
The Effectiveness of Low-frequency High-Intensity Interval Training (HIIT) in Overweight or Obese Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Individuals who fulfilled the following inclusion criteria were invited to participate in the present study: 1) Chinese male; 2) aged 18-30 years; and 3) overweight or obesity, defined as BMI ≥23 kg/m2 (classification of overweight for Hong Kong adults according to Department of Health, Hong Kong SAR Government) (13). Subjects were excluded if they had: 1) chronic medical and health condition such as cardiovascular diseases, diabetes, neurological disease, musculoskeletal disorder, cancers, and autoimmune diseases; 2) hypertension (blood pressure >140/90 mmHg); 3) contraindications to participating in physical exercise; 4) any pre-existing medical or physical issues that affected the experimental test; 5) physically active (i.e., >3 hours of moderate-intensity exercise weekly) or 6) lean overweight population (BMI ≥23 kg/m2, but percent body fat ≤20%) according to the BMI data corresponding to bioelectrical impedance estimated percent body fat cut-off value among Hong Kong Chinese adults.
Of those who were screened, 103 Chinese young adults were eligible to participate in this study. They were provided with written and verbal information on the study protocol and the possible associated discomforts and risks followed by obtaining their written informed consent to participate in this study. The study protocol and consent form were approved by the Human Subjects Ethics Sub-Committee of The Hong Kong Polytechnic University (ethics approval reference number: HSEARS20160927005-01).
This study was a single-blind, randomized, controlled trial. Subjects were randomly assigned to 1) no-intervention control (CON), 2) MICT performed thrice weekly (MICTx3/wk), 3) HIIT performed thrice weekly (HIITx3/wk), 4) twice weekly (HIITx2/wk), and 5) once weekly (HIITx1/wk). All subjects were instructed to maintain their usual daily activities. Outcome measures including aerobic capacity, body composition, blood pressure, resting heart rate, endothelial function, arterial stiffness, fasting glucose, lipids markers, adipokine marker, and inflammatory marker were assessed at baseline, 4 weeks and 8 weeks after the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- LKS Faculty of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Chinese male
- Aged 18-30 years
- Overweight or obesity, defined as BMI ≥23 kg/m2 (classification of overweight for Hong Kong adults according to Department of Health, Hong Kong SAR Government)
Exclusion Criteria:
- Chronic medical and health condition such as cardiovascular diseases, diabetes, neurological disease, musculoskeletal disorder, cancers, and autoimmune diseases
- Hypertension (blood pressure >140/90 mmHg)
- Contraindications to participating in physical exercise
- Any pre-existing medical or physical issues that affected the experimental test
- Physically active (i.e., >3 hours of moderate-intensity exercise weekly)
- Lean overweight population (BMI ≥23 kg/m2, but percent body fat ≤20%) according to the BMI data corresponding to bioelectrical impedance estimated percent body fat cut-off value among Hong Kong Chinese adults.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Subjects in this group do not received any intervention
|
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Active Comparator: Moderate Intensity Continuous Training ×3/wk
Subjects in this group will receive three sessions of Moderate-Intensity Continuous Training per week throughout the 8 weeks experimental period
|
HIIT groups performed 30-meter shuttle runs on a rooftop covered field whereas MICT group ran on a footpath with an overall flat and non-slippery road surface.
All training sessions were preceded by a 5-minute self-pace warm-up jogging and ended with a 5-minute self-pace jogging or walking cool-down.
Each session of MICT consisted of 30 minutes of continuous exercise at an intensity of 60% of heart rate reserve (HRR); [i.e., (maximal HR - resting HR) × intensity + resting HR].
For each HIIT session, the intensity was set at 90% HRR for high-intensity bouts, interspersed with active recovery at 70% HRR.
All exercise sessions were supervised by qualified athletic coach or strength and conditioning coach.
|
Active Comparator: High Intensity Interval Training×3/wk
Subjects in this group will receive three sessions of High-Intensity Interval Training per week throughout the 8 weeks experimental period
|
HIIT groups performed 30-meter shuttle runs on a rooftop covered field whereas MICT group ran on a footpath with an overall flat and non-slippery road surface.
All training sessions were preceded by a 5-minute self-pace warm-up jogging and ended with a 5-minute self-pace jogging or walking cool-down.
Each session of MICT consisted of 30 minutes of continuous exercise at an intensity of 60% of heart rate reserve (HRR); [i.e., (maximal HR - resting HR) × intensity + resting HR].
For each HIIT session, the intensity was set at 90% HRR for high-intensity bouts, interspersed with active recovery at 70% HRR.
All exercise sessions were supervised by qualified athletic coach or strength and conditioning coach.
|
Active Comparator: High Intensity Interval Training×2/wk
Subjects in this group will receive two session of High-Intensity Interval Training per week throughout the 8 weeks experimental period
|
HIIT groups performed 30-meter shuttle runs on a rooftop covered field whereas MICT group ran on a footpath with an overall flat and non-slippery road surface.
All training sessions were preceded by a 5-minute self-pace warm-up jogging and ended with a 5-minute self-pace jogging or walking cool-down.
Each session of MICT consisted of 30 minutes of continuous exercise at an intensity of 60% of heart rate reserve (HRR); [i.e., (maximal HR - resting HR) × intensity + resting HR].
For each HIIT session, the intensity was set at 90% HRR for high-intensity bouts, interspersed with active recovery at 70% HRR.
All exercise sessions were supervised by qualified athletic coach or strength and conditioning coach.
|
Active Comparator: High Intensity Interval Training×1/wk
Subjects in this group will receive one session of High-Intensity Interval Training per week throughout the 8 weeks experimental period
|
HIIT groups performed 30-meter shuttle runs on a rooftop covered field whereas MICT group ran on a footpath with an overall flat and non-slippery road surface.
All training sessions were preceded by a 5-minute self-pace warm-up jogging and ended with a 5-minute self-pace jogging or walking cool-down.
Each session of MICT consisted of 30 minutes of continuous exercise at an intensity of 60% of heart rate reserve (HRR); [i.e., (maximal HR - resting HR) × intensity + resting HR].
For each HIIT session, the intensity was set at 90% HRR for high-intensity bouts, interspersed with active recovery at 70% HRR.
All exercise sessions were supervised by qualified athletic coach or strength and conditioning coach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimated maximal oxygen consumption
Time Frame: 8 weeks
|
Estimated maximal oxygen consumption achieved during the 20-meter shuttle multistage run test were used for the assessment of aerobic fitness Unit: body weight, estimated oxygen consumption and minute will be combined to report the estimated VO2max in ml/kg/min.
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8 weeks
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Total running distance
Time Frame: 8 weeks
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Total running distance in meters achieved during the 20-meter shuttle multistage run test were used for the assessment of aerobic fitness
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8 weeks
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Total body fat percentage
Time Frame: 8 weeks
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Total body fat percentage were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
|
8 weeks
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Total body fat mass
Time Frame: 8 weeks
|
Total body fat mass in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
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8 weeks
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Total body fat-free mass percentage
Time Frame: 8 weeks
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Total body fat-free mass percentage were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
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8 weeks
|
Total fat-free mass
Time Frame: 8 weeks
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Total body fat-free mass were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
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8 weeks
|
Trunk fat mass
Time Frame: 8 weeks
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Trunk fat mass in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
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8 weeks
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Body weight
Time Frame: 8 weeks
|
Body weight in kg were assessed by a bioelectrical impedance analyzer (BC-418, Tanita, Japan).
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8 weeks
|
Body height
Time Frame: 8 weeks
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Body height in meter were assessed.
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8 weeks
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Body mass index (BMI)
Time Frame: 8 weeks
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Weight and height will be combined to report BMI in kg/m^2
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8 weeks
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Waist circumference
Time Frame: 8 weeks
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Waist circumference was determined to the nearest 0.1 cm of a contact tension tape.
The tape was applied directly to the skin at the mid-point between the lower margin of the last palpable rib and the top of the iliac crest.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure
Time Frame: 8 weeks
|
Systolic blood pressure was determined by an electronic sphygmomanometer (Accutorr Plus, Datascope, USA)
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8 weeks
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Diastolic blood pressure
Time Frame: 8 weeks
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Diastolic blood pressure was determined by an electronic sphygmomanometer (Accutorr Plus, Datascope, USA)
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8 weeks
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Mean arterial pressure
Time Frame: 8 weeks
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Mean arterial pressure was determined by an electronic sphygmomanometer (Accutorr Plus, Datascope, USA)
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8 weeks
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Resting heart rate
Time Frame: 8 weeks
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Resting heart rate was determined by an electronic sphygmomanometer (Accutorr Plus, Datascope, USA)
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8 weeks
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Endothelial function
Time Frame: 8 weeks
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Endothelial function were measured by digital plethysmography using EndoPAT 2000 device (ITAMAR Medical, Caesarea, Israel) and expressed as natural log reactive hyperemia index (LnRHI)
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8 weeks
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Arterial stiffness
Time Frame: 8 weeks
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Arterial stiffness were measured by digital plethysmography using EndoPAT 2000 device (ITAMAR Medical, Caesarea, Israel) and expressed as augmentation index normalized to heart rate of 75 bpm (AI@75)
|
8 weeks
|
Serum fasting glucose
Time Frame: 8 weeks
|
Fresh blood samples were sent to an accredited medical laboratory to measure the serum fasting glucose concentrations by commercial test kit methods with an automatic clinical chemistry analyzer (Architect CI8200, Abbott Diagnostics, USA)
|
8 weeks
|
Triglycerides
Time Frame: 8 weeks
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Fresh blood samples were sent to an accredited medical laboratory to measure the serum triglycerides concentrations by commercial test kit methods with an automatic clinical chemistry analyzer (Architect CI8200, Abbott Diagnostics, USA)
|
8 weeks
|
High-density lipoproteins (HDL) cholesterol
Time Frame: 8 weeks
|
Fresh blood samples were sent to an accredited medical laboratory to measure the serum high-density lipoproteins-cholesterol (HDL-C) concentrations by commercial test kit methods with an automatic clinical chemistry analyzer (Architect CI8200, Abbott Diagnostics, USA)
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8 weeks
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Low-density lipoprotein (LDL) cholesterol
Time Frame: 8 weeks
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Low-density lipoprotein (LDL) cholesterol in serum was measured by an automatic chemistry analyzer (AU-480, Beckman Coulter, USA)
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8 weeks
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Interleukin 6
Time Frame: 8 weeks
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Commercially available enzyme-linked immunosorbent assay kits (R&D systems, Minneapolis, MN) were used to determine interleukin 6
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8 weeks
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Tumor necrosis factor alpha
Time Frame: 8 weeks
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Commercially available enzyme-linked immunosorbent assay kits (R&D systems, Minneapolis, MN) were used to determine tumor necrosis factor alpha
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8 weeks
|
C-reactive protein
Time Frame: 8 weeks
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Commercially available enzyme-linked immunosorbent assay kits (R&D systems, Minneapolis, MN) were used to determine c-reactive protein
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8 weeks
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Adiponectin
Time Frame: 8 weeks
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Commercially available enzyme-linked immunosorbent assay kits (R&D systems, Minneapolis, MN) were used to determine adiponectin
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8 weeks
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Intercellular adhesion molecule-1
Time Frame: 8 weeks
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Commercially available enzyme-linked immunosorbent assay kits (R&D systems, Minneapolis, MN) were used to determine intercellular adhesion molecule-1
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8 weeks
|
Vascular cell adhesion molecule-1
Time Frame: 8 weeks
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Commercially available enzyme-linked immunosorbent assay kits (R&D systems, Minneapolis, MN) were used to determine vascular cell adhesion molecule-1
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8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIIT001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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