Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060776) titled 'Effects of Electrical Stimulation Applied to the Entire Lower-Limb Musculature on Energy Metabolism' on March 1.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Tokoha University
Condition:
Condition - healthy subjects
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To elucidate the effects of electrical stimulation applied to the entire lower-limb musculature on energy metabolism and to examine its applicability for individuals who are unable to perform exercise at sufficient intensity.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Electrical Stimulation (ES) condition.
Electrical stimulation was applied to the entire lower-limb musculature, with electrode placement over the abdomen (above the iliac crest), both thighs (above the patella), and both lower legs (above the medial and lateral malleoli). Participants were positioned in the supine position. The stimulation mode was set to the metabolic mode (4 Hz). The pulse width was adjusted within the manufacturer-specified range of 56-260 usec, and an exponentially ramping waveform was used at the onset of stimulation. The maximum output current was 48 mA. Stimulation intensity was regulated using a 10-point pain scale and was adjusted as needed to reach the highest tolerable level without discomfort, corresponding approximately to a rating of "8".
Interventions/Control_2 - Control condition (CC).
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - students who agreed to participate in the study and submitted a signed informed-consent form
Key exclusion criteria - individuals who are receiving outpatient treatment for illness or injury, or those who have pain in the lower back or lower limbs
Target Size - 40
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 09 Month 19 Day
Date of IRB - 2025 Year 09 Month 19 Day
Anticipated trial start date - 2025 Year 10 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=R000069537
Disclaimer: Curated by HT Syndication.