Vagal Nerve Stimulation as Therapeutic Approach on Metabolic Syndrome
- Conditions
- Metabolic Syndrome
- Interventions
- Device: Vagal StimulationOther: Circuit training program
- Registration Number
- NCT05785117
- Lead Sponsor
- Rana Elbanna
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 70
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.
- Vagotomy.
- Diathermy.
- Wallowing difficulties.
- Dyspnea.
- Cardiac arrhythmia.
- Seizure.
- Previous brain injury or surgery.
- Dysautonomia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Vagus nerve stimulation group Vagal Stimulation Vagus nerve stimulation group Vagus nerve stimulation group Circuit training program Vagus nerve stimulation group Circuit weight training group Group Circuit training program Circuit weight training group Group
- Primary Outcome Measures
Name Time Method Emotional eating 4 weeks Emotional Eating was measured by a 15-item version of the Emotional Eating Scale. The scale required responses from 0 (no desire to eat) to 4 (an overwhelming urge to eat) based on "... the extent which the following feelings presently lead you to feel an urge to eat. A lower score indicated less of an urge to eat when the designated emotional state was present.
Cortisol level 4 weeks Participants use a disposable plastic straw to 'drool' saliva into the tube after collecting it in their mouths for a predetermined period of time (one minute) Saliva samples for cortisol measurement kept at room temperature until they are examined in a lab (4 to 6 hours)
Patient satisfaction measures 4 weeks The Short Assessment of Patient Satisfaction (SAPS) is a seven-item scale that can be utilized to measure patient satisfaction with their treatment.
The seven-item Short Assessment of Patient Satisfaction (SAPS), which is scored on a 5-point scale (0-4) SAPS has a continuous score range of 0 to 28. SAPS categorical responses include 0-10 very dissatisfied, 11-18 dissatisfied, 19-26 satisfied, and 27-28 very satisfied.
- Secondary Outcome Measures
Name Time Method Body weight 4 weeks After an eight-hour fast, body weight was taken between 7:00 and 10:00 am using a digital scale that was accurate to ±0.1 kg
Trial Locations
- Locations (1)
Outpatient clinic faculty of physical therapy at Cairo University
🇪🇬Giza, Egypt