Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome

NCT ID: NCT05785117

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2023-05-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Vagus nerve stimulation group

Vagus nerve stimulation group

Group Type: EXPERIMENTAL

Vagal Stimulation

Intervention Type: DEVICE

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)

Circuit training program

Intervention Type: OTHER

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

Circuit weight training group Group

Circuit weight training group Group

Group Type: EXPERIMENTAL

Circuit training program

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: DEVICE

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Rana Elbanna

OTHER

Sponsor Role: lead

Responsible Party

Rana Elbanna

lecturer at faculty of physical therapy at Cairo University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Outpatient clinic faculty of physical therapy at Cairo University

Giza, , Egypt

Countries

Egypt

References

Elbanna RHM, Elabd SOA, Saleh MSM, Alghitany SIA. Effect of adding noninvasive auricular Vagal nerve stimulation to exercise program on emotional eating and stress responsiveness in patient with metabolic syndrome. Disabil Rehabil. 2025 May 17:1-8. doi: 10.1080/09638288.2025.2506824. Online ahead of print.

Reference Type: DERIVED

PMID: 40382680 (View on PubMed)

Other Identifiers

P.T.REC/012/003818

Identifier Type: -

Identifier Source: org_study_id