- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06966414
- Original Trial
Effects of Different Timing of Bodyweight High-intensity Exercise on Human Behaviours
Effects of Bodyweight High-intensity Exercise at Different Times of Day on 72-hour Eating Behaviours and Physical Activity in Physically Inactive Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Eligibility and Consent Confirmation:
Prior to the one-week preliminary test, participants will undergo eligibility screening, including measurements of height, weight, and body composition. After the researchers will provide a detailed explanation of the experimental procedures, participants can decide whether to participate in the study. Eligible participants will complete a set of high-intensity bodyweight exercise to familiarize themselves with the exercise. Subsequently, the researchers will explain the use of pedometers and distributed dietary record forms.
During a one-week preliminary test, participants will be instructed to record their physical activity levels measured in steps, sleep duration including wake-up and sleep times, and dietary behaviours through photographs taken (2 weekdays and 1 weekend day) over a period of 7 consecutive days. Participants will be allowed to take part in this study, once they meet the inclusion criteria: 1) an average daily step count of less than 7,500 over the course of the week and 2) a wake-up time no later than 11:00 AM).
Exercise intervention:
Two main trials will be separated by at least one week - exercise in the morning (08:00 to 11:00 AM) or exercise in the evening (18:00 to 21:00 PM).
In both trials, participants will complete the first Visual Analogue Scale (VAS) for subjective appetite upon waking, wear a pedometer and an accelerometer, and record energy intake and physical activity over a 3-day period (the day before exercise intervention, the exercise day and the day after exercise intervention). Upon arrival at the laboratory, participants will complete the second VAS, followed by a 15-minute waiting period before commencing the exercise. Participants will perform high-intensity bodyweight exercise (3 sets with 8 exercises with a cycle of 30 seconds exercise and 30 seconds rest), followed by a 15-minute rest period, after which they will complete the third VAS.
Heart rate and Rating of Perceived Exertion (RPE) will be measured regularly during exercise. Energy balance (e.g., energy intake and spontaneous physical activity) will be assessed using a food diary, Actigraph wGT3x-BT accelerometer (Actigraph Co., Ltd., Pensacola, FL, USA), and pedometer (Realalt, Goldhat Ltd., UK), which will be worn starting from the night two days before the experiment and removed after waking up two days post-experiment.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yung-Chih Chen, PhD
- Email: yc.chen@ntnu.edu.tw
Study Contact Backup
- Name: Chen, PhD
- Phone Number: +886-2-77496979
Study Locations
-
-
-
Taipei, Taiwan
- Recruiting
- National Taiwan Normal University
-
Contact:
- Yung-Chih Chen, PhD
- Email: yc.chen@ntnu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged between 20 and 50 years, with a BMI ranging from 19 to 27 kg/m².
- Classified as having "low" physical activity levels (750 Metabolic Equivalents / week) according to the International Physical Activity Questionnaire (IPAQ).
- Engaged in moderate-intensity exercise for no more than 3 days per week and less than 30 minutes per session in the 3 months preceding the study.
- Maintained a stable body weight (± 3 kg) during the 3 months prior to the main experiment.
- Not taking any medications, supplements, or vitamins that might affect food intake, appetite, physical activity, weight loss, or metabolism.
- Free from cardiovascular and metabolic diseases.
- Not pregnant or planning to become pregnant.
- Not currently on a diet or undergoing any specific dietary interventions (e.g., intermittent fasting, ketogenic diet).
- No injuries or surgical wounds preventing physical activity.
- Regular sleep patterns, averaging 7-9 hours per night, with no shift work.
- No habits of heavy alcohol consumption or smoking.
Exclusion Criteria:
- Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia.
- Taking medications that may influence lipid or carbohydrate metabolism or immune system function.
- Unable to take part in exercise for any reason (e.g., injury or disability) or a positive response to any questions on the Physical Activity Readiness questionnaire (PAR-Q).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Morning exercise
Participants performed bodyweight exercise in the morning between 08:00 to 11:00 AM.
|
Participants performed bodyweight exercise in the morning between 08:00 to 11:00 AM.
|
|
Experimental: Evening exercise
Participants performed bodyweight exercise in the morning between 18:00 to 21:00 PM.
|
Participants performed bodyweight exercise in the morning between 18:00 to 21:00 PM.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: 72 hours (24 hours before exercise day, exercise day and 24 hours after exercise day)
|
Changes in physical activity intensity (minutes and percentage during 72 hours) and levels (minutes and percentage during 72 hours) between trials
|
72 hours (24 hours before exercise day, exercise day and 24 hours after exercise day)
|
|
Sedentary behaviour
Time Frame: 72 hours (24 hours before exercise day, exercise day and 24 hours after exercise day)
|
Changes in sedentary behaviour (minutes and percentage during 72 hours) between trials
|
72 hours (24 hours before exercise day, exercise day and 24 hours after exercise day)
|
|
Energy intake
Time Frame: 72 hours (24 hours before exercise day, 24 hours during exercise day and 24 hours after exercise day)
|
Changes in total and macronutrient energy intake between trials
|
72 hours (24 hours before exercise day, 24 hours during exercise day and 24 hours after exercise day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: During 45 minutes exercise
|
Changes in heart rate (bmp) during exercise between trials
|
During 45 minutes exercise
|
|
Rating of Perceived Exertion (RPE)
Time Frame: During 45 minutes exercise
|
Changes in Rating of Perceived Exertion using Borg 6-20 scale (6 indicates no exertion and 20 indicates maximal effort) during exercise between trials
|
During 45 minutes exercise
|
|
Visual analogue scale (VAS)
Time Frame: Baseline upon wake up, 15 minutes before exercise and 15 minutes after exercise
|
Changes in Visual analogue scale (Mood and appetite) using 0-100 mm scale (0 indicates not at all and 100 indicates very much) during exercise between trials
|
Baseline upon wake up, 15 minutes before exercise and 15 minutes after exercise
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202405HM084-2
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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