NCT06383442

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
Last Updated

April 25, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

April 15, 2024

Last Update Submit

April 24, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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).

  • 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).

  • 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).

  • 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).

  • 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 Outcomes (8)

  • Glucose

    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).

  • Triglycerides

    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).

  • low-density lipoprotein (LDL)

    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).

  • high-density lipoprotein (HDL)

    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).

  • creatine kinase (CK) level

    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).

  • +3 more secondary outcomes

Study Arms (3)

Control group

NO INTERVENTION

M-HIIT

EXPERIMENTAL
Other: M-HIIT

L-HIIT

EXPERIMENTAL
Other: L-HIIT

Interventions

L-HIITOTHER

the long-interval HIIT group (4 × 4 min Exercise/4 min Rest)

L-HIIT
M-HIITOTHER

the medium-interval HIIT group (8 × 2 min Exercise /2 min Rest)

M-HIIT

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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:
  • Have smoking and drinking habits.
  • People who have stroke, type 1 and type 2 diabetes, neuromuscular disease, so that they cannot participate in physical activities.
  • Chronic obstructive lung disease, asthma, interstitial lung disease or alveolar cyst fibrosis.
  • Metabolic diseases include thyroid disease, kidney disease (kidney, bladder stones) or liver disease.
  • Those with arrhythmia, a rhythm regulator, severe cardiovascular disease, peripheral vascular disease or cerebrovascular disease.
  • People with epilepsy and rheumatoid arthritis.
  • Those who have implanted artificial joints in the past six months and have had recent surgery.
  • Migraine, acute thrombosis and hernia.
  • Those who have engaged in strenuous exercise or have muscle aches within 24 hours before the experiment.
  • People who feel unwell due to other reasons during the experiment.
  • People with severe food allergies.
  • Have hospitalization records within three months.
  • People with cognitive impairment.
  • Take any drugs that affect the function of the nervous system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants were evenly distributed according to a counterbalanced design and divided into three different groups by the body fat percentage of subjects: 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. Target intensities of each interval bout, exercise and rest (Ex./R.), were 85-90% VO2peak/65-70% VO2peak zones, respectively.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2024

First Posted

April 25, 2024

Study Start

May 25, 2021

Primary Completion

July 31, 2023

Study Completion

November 22, 2023

Last Updated

April 25, 2024

Record last verified: 2024-04

Locations