Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

Rana Elbanna

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Other: Circuit training program; Device: Vagal Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05785117

P.T.REC/012/003818

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Male

Ages: 45 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

having two or more than one of the following:

• Type 2 diabetes Miletus
• Hypertensive.
• Abnormal Cholesterol or Triglyceride level.
• BMI more than 30 kg/m
• Waist circumference more than 94 cm.

Exclusion criteria

• Vagotomy.
• Diathermy.
• Wallowing difficulties.
• Dyspnea.
• Cardiac arrhythmia.
• Seizure.
• Previous brain injury or surgery.
• Dysautonomia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Vagus nerve stimulation group

Experimental group

Description:

Vagus nerve stimulation group

Treatment:

Device: Vagal Stimulation

Other: Circuit training program

Circuit weight training group Group

Experimental group

Description:

Circuit weight training group Group

Treatment:

Other: Circuit training program