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Neuromuscular Electrical Stimulation: A Novel Treatment for Improving Metabolism

NCT ID: NCT06722391

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-19

Study Completion Date

2031-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance

Keywords

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Neuromuscular Electrical Stimulation Glucose Continuous Monitor Blood Glucose Obesity Resting Metabolic rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Participants will receive stimulation only up to sensory level.

Group Type PLACEBO_COMPARATOR

Neuromuscular Electrical Stimulation (Sensory)

Intervention Type DEVICE

Group will receive Electrical Stimulation up to sensory level

NMES

Participants will receive stimulation up to maximum tolerable level.

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type DEVICE

Group will receive Electrical Stimulation up to maximum tolerable level

Resistance Training

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

Group Type PLACEBO_COMPARATOR

Neuromuscular Electrical Stimulation (Sensory)

Intervention Type DEVICE

Group will receive Electrical Stimulation up to sensory level

Resistance Training

Intervention Type OTHER

Group will receive exercise training.

Resistance Training + NMES

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

Group Type EXPERIMENTAL

Neuromuscular Electrical Stimulation

Intervention Type DEVICE

Group will receive Electrical Stimulation up to maximum tolerable level

Resistance Training

Intervention Type OTHER

Group will receive exercise training.

Interventions

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Neuromuscular Electrical Stimulation (Sensory)

Group will receive Electrical Stimulation up to sensory level

Intervention Type DEVICE

Neuromuscular Electrical Stimulation

Group will receive Electrical Stimulation up to maximum tolerable level

Intervention Type DEVICE

Resistance Training

Group will receive exercise training.

Intervention Type OTHER

Other Intervention Names

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Control NMES Group Control

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Texas, El Paso

OTHER

Sponsor Role lead

Responsible Party

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Sudip Bajpeyi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Texas at El Paso

El Paso, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sudip Bajpeyi, PhD

Role: CONTACT

Phone: 9157475461

Email: [email protected]

Facility Contacts

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Sudip Bajpeyi, PhD

Role: primary

Other Identifiers

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2205558

Identifier Type: -

Identifier Source: org_study_id