Tokyo, Jan. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060450) titled 'Comparison of Physiological Responses to Constant Load Exercise at Ventilatory Threshold Intensity and High-Intensity Interval Exercise During Wheelchair Propulsion' on Jan. 23.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Dose comparison
Primary Sponsor:
Institute - Fukushima Medical University
Condition:
Condition - Healthy participants
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to clarify the physiological characteristics associated with different exercise modalities during wheelchair propulsion. To achieve this, we compared steady-state exercise and high-intensity interval exercise by comprehensively analyzing the time-series changes in upper and lower limb muscle oxygenation, PFC cerebral oxygenation, cardiac output, respiratory metabolism, and muscle activity.
Basic objectives2 - Bio-equivalence
Intervention:
Interventions/Control_1 - Cardiopulmonary exercise testing
Interventions/Control_2 - Wheelchair propulsion exercise
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male
Key inclusion criteria - 1. Healthy males aged 18 years or older
2. No history of orthopedic disorders in the upper or lower limbs that would interfere with exercise
3. No history of cardiopulmonary or neurological diseases
4. Individuals who provided written informed consent after receiving a full explanation of the study's purpose and procedures
Key exclusion criteria - 1. History of cardiovascular disease (e.g., arrhythmia, heart failure, severe hypertension)
2. History of respiratory disease (e.g., asthma, chronic respiratory failure)
3. Acute or chronic orthopedic pain or disorders that limit exercise performance
4. Difficulty attaching electrodes or sensors due to dermatological conditions or skin allergies
5. Initiation of a new high-intensity exercise training regimen during the study period
6. Individuals deemed by the investigator to be unable to participate safely
7. Principal investigator or co-investigators of the present study
Target Size - 16
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 01 Month 21 Day
Date of IRB - 2026 Year 01 Month 21 Day
Anticipated trial start date - 2026 Year 01 Month 23 Day
Last follow-up date - 2027 Year 04 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069159
Disclaimer: Curated by HT Syndication.