Tokyo, Oct. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063212) titled 'A randomised controlled trial on the effects of high-intensity interval training and aerobic exercise on mitochondrial-related parameters and exercise tolerance' on Oct. 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Tohoku University
Condition:
Condition - Healthy subjects
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - The purpose of this study is to compare the effects of high-intensity interval training (HIIT) and moderate-intensity aerobic exercise on mitochondrial-related indicators (mitochondrial DNA copy number) and exercise tolerance indicators (anaerobic threshold, AT) in healthy adults.
Additionally, as a secondary objective, we will examine the relationship between changes in mitochondrial-related indicators and changes in exercise capacity indicators, and explore the potential of mitochondrial-related indicators as new measures for evaluating exercise load.
Furthermore, we will examine the relationship with maximum oxygen uptake and the sweat lactate threshold to evaluate the effectiveness of exercise intervention from the perspective of mitochondrial function.
Basic objectives2 - Bio-equivalence
Intervention:
Interventions/Control_1 - High-Intensity Interval Training (HIIT) Group
Exercise Equipment: Stationary Bike
Warm-up: Warm-up and cool-down performed before and after exercise
High-Intensity Exercise: High-intensity exercise determined by a preliminary ramp test. Repeated with intervals.
Interventions/Control_2 - Control Group
Exercise equipment: Stationary bicycle ergometer
High-Intensity Interval Training (HIIT) Group
Exercise Equipment: Stationary Bike
Warm-up: Warm-up and cool-down performed before and after exercise (to match the conditions of Group 1)
Exercise protocol: moderate-intensity aerobic exercise (constant load)
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - (1) Disease Name: Healthy Individuals
(2) Disease Stage: None
(3) Age: 18 years or older, but under 50 years of age (at the time of enrollment)
(4) Gender: Any
(5) Individuals who have provided written informed consent to participate in the study
Key exclusion criteria - 1. Individuals who have been diagnosed with or are suspected of having any of the following conditions during the period below:
Heart disease
Respiratory disease
Metabolic disease
Neurological disease
Muscle disease
2. Individuals who meet any of the following conditions:
Individuals with absolute contraindications to exercise stress testing
Individuals with severe skin conditions at the device implantation site
Pregnant women, women who may be pregnant, or women who are breastfeeding
Individuals who refuse to participate in this study
Individuals whom the principal investigator or a co-investigator deems unsuitable for inclusion in the study
Target Size - 30
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 06 Day
Anticipated trial start date - 2026 Year 10 Month 27 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072344
Disclaimer: Curated by HT Syndication.