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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06383442
Other study ID # N202103041
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 25, 2021
Est. completion date November 22, 2023

Study information

Verified date April 2024
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

36 middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week) and the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss.


Description:

Aging, obesity, have been shown to lead to higher oxidative stress and chronic inflammation. However, high-intensity interval training (HIIT) has anti-inflammatory and anti-obesity benefits. Different training prescriptions may also affect improvements. Therefore, this study will explore the optimal HIIT prescription to improve fat, inflammation, metabolism, and exercise performance in overweight middle-aged and older adults. Thirty-six middle-aged with overweight adults were divided into three groups: 1. L-HIIT group: the long-interval HIIT group (4 × 4 min Exercise/4 min Rest), 2. M-HIIT group: the medium-interval HIIT group (8 × 2 min Exercise/2 min Rest), 3. Control group: no exercise intervention. All groups carried out the training stage for 8 weeks (three sessions per week), then the detraining stage for 4 weeks in order to investigate the effects induced by different HIIT interventions on inflammation, metabolic adaptation, anti-fatigue and exercise performance, and fat loss.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date November 22, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility Inclusion Criteria: - Recruit people who are overweight or obese (BMI between 24-35) who are 20-65 years old and have no exercise habits in a sitting lifestyle. Exclusion Criteria: - If there are any of the following circumstances, they are not allowed to participate in this research and are included in the listing conditions of this case: 1. Have smoking and drinking habits. 2. People who have stroke, type 1 and type 2 diabetes, neuromuscular disease, so that they cannot participate in physical activities. 3. Chronic obstructive lung disease, asthma, interstitial lung disease or alveolar cyst fibrosis. 4. Metabolic diseases include thyroid disease, kidney disease (kidney, bladder stones) or liver disease. 5. Those with arrhythmia, a rhythm regulator, severe cardiovascular disease, peripheral vascular disease or cerebrovascular disease. 6. People with epilepsy and rheumatoid arthritis. 7. Those who have implanted artificial joints in the past six months and have had recent surgery. 8. Migraine, acute thrombosis and hernia. 9. Those who have engaged in strenuous exercise or have muscle aches within 24 hours before the experiment. 10. People who feel unwell due to other reasons during the experiment. 11. People with severe food allergies. 12. Have hospitalization records within three months. 13. People with cognitive impairment. 14. Take any drugs that affect the function of the nervous system.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
L-HIIT
the long-interval HIIT group (4 × 4 min Exercise/4 min Rest)
M-HIIT
the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest)

Locations

Country Name City State
Taiwan Taipei Medical University Taipei

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Aerobic Capacity Test a graded exercise test (GXT) was performed using a stationary bike ergometer (ergo_bike Premium 8i, Flugplatzstr, Germany) to assess the subject's VO2peak Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Primary Aerobic Capacity Test All subjects wore polar heart rate belts (Polar Electro Oy, Kempele, Finland) to monitor maximum heart rate during aerobic capacity testing. Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Primary Anti-fatigue performance After a standard warm-up, all subjects were assessed with the classical Wingate (WAnT) on a cycloergometer (Monark 894E, Varberg, Sweden) in a 30 s "go all out" ultramax test. The seat height was adjusted to the satisfaction of each participant, and toe clips prevented the feet from slipping off the pedals. Before the initial test, the subjects warmed up for 5 min, and the power was approximately 50 W. After the warm-up, two preparation exercises lasting 3 s, during which the actual test load was 3% of their own body weight, were applied to accustom the participant to resistance. The test started, and the resistance was set on the friction belt of the dynamometer. External loading was estimated individually at 5% body weight. The average relative mean power parameters were recorded. Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Primary skinfold thickness The sum of skinfold thickness at seven sites (triceps, chest, subscapular muscle, upper ilium, abdomen, front thigh, and leg) was measured by using a skinfold caliper (Beta Technology, Santa Cruz, California, USA). Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Primary Body composition_body fat The multi-frequency principle was applied to measure body composition by using a bioelectrical impedance analyzer (BIA) on an InBody 570 device (In-body, Seoul, South Korea). To perform the measurements, after the subjects' palms and soles were removed from the sensors, the subjects stood on the footing electrodes and held the sensing handles with two hands. During the measurements, the subjects kept their arms open and left their bodies at an angle of 30° without speaking or moving. The subjects also fasted for at least 8 h before the test. The body fat were meansure Primary Outcomes were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary Glucose Safety is assessed function of Glucose (70~100 mg/dL) were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary Triglycerides Safety is assessed function of blood lipid such as Triglycerides (<150 mg/dL) were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary low-density lipoprotein (LDL) Safety is assessed function of blood lipid such as LDL (0~140mg/dl) were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary high-density lipoprotein (HDL) Safety is assessed function of blood lipid such as LDL (0~140mg/dl) were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary creatine kinase (CK) level At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Assess serum CK(Creatine Kinase, U/L) to monitor physiological fitness. Serum CK (U/L), were assessed for monitoring physiological adaptation. All biochemical indices were assessed using an autoanalyzer (Hitachi 7060, Tokyo, Japan). were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary C-reactive protein (CRP) At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human CRP (Cayman, Mich, USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary tumor necrosis factor (TNF)-R1 At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human TNF-R1 (R & D SYSTEMS, MN USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
Secondary TNF-R2 At designated time points in the recovery period, blood samples were collected with brachial venous catheters. Used commercial kit human TNF-R1 (R & D SYSTEMS, MN USA) and Elisa reader (PerkinElmer, Massachusetts, USA) for analysis were measured before the intervention (at week 0), after eight weeks of HIIT intervention (at week 8), and after the following four weeks of detraining (at week 12).
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