Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

The University of Texas System (UT)

Status: Enrolling

Conditions: Insulin Resistance

Treatments: Other: Resistance Training; Device: Neuromuscular Electrical Stimulation (Sensory); Device: Neuromuscular Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06722391

2205558

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Overweight/Obese (BMI ≥25)
• Sedentary Lifestyle: Physical Activity Level<1.4
• Less than 150min/week of structured Exercise

Exclusion criteria

• Use of anti-hypertensive, lipid-lowering or insulin sensitizing medications
• Excessive alcohol, drug abuse, smoking
• Pregnant Women
• Unwilling to adhere to the study Intervention

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 4 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Participants will receive stimulation only up to sensory level.

Treatment:

Device: Neuromuscular Electrical Stimulation (Sensory)

NMES

Experimental group

Description:

Participants will receive stimulation up to maximum tolerable level.

Treatment:

Device: Neuromuscular Electrical Stimulation

Resistance Training

Placebo Comparator group

Description:

Participants will receive exercise training with stimulation up to sensory level.

Treatment:

Device: Neuromuscular Electrical Stimulation (Sensory)

Other: Resistance Training

Resistance Training + NMES

Experimental group

Description:

Participants will receive exercise training with stimulation up to maximum tolerable intensity.

Treatment:

Device: Neuromuscular Electrical Stimulation

Other: Resistance Training