Tokyo, April 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061225) titled 'Effects of Mask-Based Intermittent Hypoxic Training on Improvement of Exercise Tolerance' on April 10.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Juntendo University
Condition:
Condition - Study 1: Healthy adults (18 to 30 years)
Study 2: Healthy older adults (65 years and above)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - As a fundamental study aimed at improving exercise tolerance in older patients with chronic diseases, this study investigates the effects of mask-based hypoxic training on exercise tolerance in healthy adults and healthy older individuals.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Intermittent hypoxic training
Interventions/Control_2 - Intermittent hypoxic training plus electrical muscle stimulation
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Study 1: Healthy adults aged 18 to 30 years (undergraduate or graduate students)
Study 2: Healthy older adults aged 65 years and above
Key exclusion criteria - 1. Smokers
2. Individuals receiving pharmacological treatment for anemia
3. Individuals belonging to athletic clubs or engaging in regular training
4. Individuals with implanted devices such as pacemakers
5. Individuals for whom cardiopulmonary exercise testing is difficult due to orthopedic, respiratory, or cardiovascular diseases
6. Individuals who have undergone joint replacement surgery
7. Individuals at risk of exacerbation of underlying diseases (e.g., orthopedic, respiratory, cardiovascular diseases, diabetes) due to exercise therapy
8. Individuals who have required hospitalization for any underlying disease within the past 6 months
9. Individuals who are regularly receiving medical care for underlying diseases must have permission from their attending physician
Target Size - 15
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2024 Year 10 Month 31 Day
Date of IRB - 2025 Year 01 Month 28 Day
Anticipated trial start date - 2025 Year 07 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=R000070063
Disclaimer: Curated by HT Syndication.
