NCT06722391

Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Texas, El Paso · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Once written consent is obtained, the participant will be provided with an accelerometer to be worn for 7 days to assess current physical activity levels. Subjects will be provided with a standardized diet (55/15/30% CHO/PRO/FAT) prior to collection of pre-intervention data of insulin sensitivity. Individuals will then participate in an 8-week electrical stimulation intervention (30min/day, 3x/week) and randomized into placebo/control, NMES, resistance training combined with NMES (RT +NMES), or resistance training (RT) group (n=20 per group), followed by collection of post-intervention data. The control group will receive electrical stimulation up to sensory level, the NMES group will receive stimulation up to tolerable intensity to induce visible muscle contraction, the RT+ NMES will receive stimulation up to tolerable intensity during resistance training, and the RT group will only receive exercise training. Control and NMES group will self administer stimulation at home. Pre-and post-intervention data includes measurements for body composition, resting metabolic rate, VO2max, insulin sensitivity, and comprehensive blood work.

Conditions

• Insulin Resistance

Interventions

Type	Name	Description
DEVICE	Neuromuscular Electrical Stimulation (Sensory)	Group will receive Electrical Stimulation up to sensory level
DEVICE	Neuromuscular Electrical Stimulation	Group will receive Electrical Stimulation up to maximum tolerable level
OTHER	Resistance Training	Group will receive exercise training.

Timeline

• Start date: 2024-08-19
• Primary completion: 2029-09-01
• Completion: 2031-09-01
• First posted: 2024-12-09
• Last updated: 2024-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study