Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

Last updated: August 10, 2024
Sponsor: Rana Elbanna
Overall Status: Completed

Phase

N/A

Condition

Metabolic Syndrome

Diabetes Prevention

High Cholesterol (Hyperlipidemia)

Treatment

Circuit training program

Vagal Stimulation

Clinical Study ID

NCT05785117
P.T.REC/012/003818
  • Ages 45-55
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Vagotomy.

  • Diathermy.

  • Wallowing difficulties.

  • Dyspnea.

  • Cardiac arrhythmia.

  • Seizure.

  • Previous brain injury or surgery.

  • Dysautonomia.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Circuit training program
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
May 30, 2023

Study 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.

Connect with a study center

  • Outpatient clinic faculty of physical therapy at Cairo University

    Giza, 12613
    Egypt

    Site Not Available

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