NCT05785117

Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

Effect of Non-invasive Auricular Vagal Nerve Stimulation Versus Circuit Weight Training on Nutritional Modulation in Patient With Metabolic Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Rana Elbanna · Academic / Other
• Sex: Male
• Age: 45 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

Participants were randomly assigned to two groups prior to their second visit: the Vagus nerve stimulation group (VNS) and the circuit training program. The randomization processes were conducted in Excel utilizing a random-number generator. Prior to the second visit, each participants' target exercise heart rate ranges were determined. Vagus nerve stimulation group(VNS) Patients rested on their sides in a sitting position. Following regular disinfection of the stimulation locations, ear clips were placed in the ear region (auricular concha) at the stimulation site. The training regimen included ten different forms of resistance and aerobic exercises.

Detailed description

Vagus nerve stimulation group Group: 1. Each participant signed a consent form after receiving a detailed explanation about the procedure. 2. Patients rested on their sides in a sitting position. 3. Disinfection of the stimulation locations. 4. Ear clips were placed in the ear region (auricular concha) at the stimulation site. 5. Emotional eating was assessed by Emotional Eating Scale. 5. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS). 6. Cortisol was assessed in lab. 7. After one month all the assessment procedure will be repeated again. Circuit training group Group: 1. Each participant will signed a consent form after receiving a detailed explanation about the procedure. 2. The training regimen included ten different forms of resistance and aerobic exercises. 3. Emotional eating was assessed by Emotional Eating Scale. 4. Patient satisfaction was assessed by The Short Assessment of Patient Satisfaction (SAPS). 5 Cortisol was assessed in lab. 6. After one month all the assessment procedure will be repeated again.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
DEVICE	Vagal Stimulation	ear clips were placed in the ear region (auricular concha) at the stimulation site. The following stimulation settings were used: 1) density wave set to 20 Hz with a wave width of less than 1 ms; 2) intensity tuned to the patient's tolerance (4-6 mA)
OTHER	Circuit training program	The training regimen included ten different forms of resistance and aerobic exercise that were done three times a week for four weeks. The resistance training program included push-ups, squats, crunches, lunges, and a superman exercise program that included light jumping, jogging on the spot, foot stomping, steps, and jumping jacks

Timeline

• Start date: 2023-03-01
• Primary completion: 2023-04-30
• Completion: 2023-05-30
• First posted: 2023-03-27
• Last updated: 2024-08-14

Locations

1 site across 1 country: Egypt