Tokyo, April 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061132) titled 'Investigation of associations between changes in cerebral blood flow and oxygen metabolism and exerkines (particles derived from contracting muscles) evoked by high-intensity exercise; a study using positron emission tomography (PET)' on April 6.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Condition:
Condition - Healthy young men
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Regional cerebral blood flow (CBF) is investigated after the session of high-intensity aerobic exercise so that the relationships between regional CBF and blood exerkines levels, such as irisin, BDNF and cathepsin B, which have roles for neural plasticity and neuroprotective effect, are explored.
To identify the coupling of CBF and oxygen metabolism in the prefrontal cortex (PFC), that regulates will to perform exercise and involves the underlying mechanism for mood change, the ratio of CBF to metabolic rate for oxygen (CMRO2) is analyzed by simultaneous measurements using PET and near infrared spectroscopy, which enables to calculate CMRO2 applying cerebral hemoglobin oxygen saturation. We also clarify exercise-related self-efficacy, state of stress and fatigue and personal characteristics in traits that are related with mood change induced by exercise.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - At rest and exercise intervention of 28 min (vigorous-intensity cycling exercise followed by a moderate-intensity bout)
Eligibility:
Age-lower limit - 20
years-old
=
Gender - Male
Key inclusion criteria - Healthy young men who have been engaged in high-intensity aerobic exercise and can tolerate 28 minutes of moderate to vigorous aerobic exercise.
Key exclusion criteria - 1. A history of neuropsychiatric disorders such as epilepsy, major depression, or schizophrenia.
2. Habit of smoke.
3. Contraindication for head MRI examination.
4. A history of severe drug hypersensitivity.
5. A history of cardiovascular disease.
6. Current diagnosis of internal diseases such as chronic anemia or chronic renal failure.
7. Any other reason by which the principal investigator determines to exclude from the participation for this study
Target Size - 14
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 02 Day
Date of IRB - 2025 Year 10 Month 15 Day
Anticipated trial start date - 2026 Year 06 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069611
Disclaimer: Curated by HT Syndication.