Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals

Healthy Clinical Trial

Official title:

Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04832347
• Other study ID #: VNS002
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: July 7, 2021

Study information

• Verified date: April 2021
• Source: Sinop University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Objective: Sympathetic activity starts to increase during exercise. At the end of the exercise, while sympathetic activation decreases, parasympathetic activity increases. Sympathetic and parasympathetic excursions achieve homeostasis. Most of the parasympathetic activity effects are vagus code. It is aimed to compare the comparison of exercise and vagus therapy in these healthy individuals.

Description:

Objective: The aim of this study is to compare the effectiveness of stabilization exercise and vagus nerve stimulation on healthy individuals. Research Method: This randomized controlled trial; It is planned to be carried out on students and administrative / academic staff at Gümüşhane University. First of all, the application will be explained to the individuals and online consent will be obtained from the individuals for the application. Group 1 will be given stabilization exercises. Vagus therapy will be applied to Group 2. Group 3 will be followed as a control group and no application will be made. Evaluations; 1. Evaluation of autonomous parameters; It was planned to measure pulse and heart rate variability. 2. Chest circumference measurement 3. In addition, it is planned to use "Perceived Stress Scale", "Pitsburg Sleep Quality Scale" and "Fatigue Severity Scale" questionnaires. All individuals were planned to be evaluated before, after and 1 month after the application.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: July 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy volunteer individuals (Female and Male),
• Individuals between the ages of 18-50,
• Obtaining the necessary consent for the study,
• No trauma or surgery history in the last 6 months,
• Does not have any chronic disease (Obesity, Diabetes, Hypertension, Osteoporosis)

Exclusion Criteria:

• Individuals not wanting to continue working.
• Individuals having disability during the work process

Related Conditions & MeSH terms

• Activity, Motor
• Fatigue
• Healthy
• Sleep
• Stress, Physiological

Intervention

Other:
• Exercise
Exercise Group will be given stabilization exercises for a total of 24 sessions, 3 times a week for 8 weeks, each session for 45 minutes.
• Vagus Nerve Stimulation
Vagus therapy will be applied for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.

Locations

Country	Name	City	State
Turkey	Sefa Haktan Hatik	Sinop	Turkeli

Sponsors (1)

Lead Sponsor	Collaborator
Sinop University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of autonomous parameters	Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.	Change from Systolic / diastolic blood pressure (mmHg) at 2 months.
Secondary	Chest circumference measurement	It was measured with a tape measure in the axillary, xiphoid and subcostal regions while at normal (cm), max inspiratory(cm) and max expiration(cm).	Change from a tape measure in the axillary, xiphoid and subcostal regions while at normal (cm) at 2 months, max inspiratory(cm) and max expiration(cm)
Secondary	Perceived Stress Scale	The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. The scale also includes a number of direct queries about current levels of experienced stress.PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items. A short 4 item scale can be made from questions 2, 4, 5 and 10 of the PSS 10 item scale.	Change of the scores obtained in the questionnaires at 2 months.
Secondary	Pitsburg Sleep Quality Scale	The PSQI was developed by Buysse et al43 in 1989 and is a 24-question instrument. The PSQI provides a quantitative measurement of sleep quality that is used to describe good and bad sleep. The PSQI has 7 subscales: (1) subjective sleep quality (component 1); (2) sleep latency (component 2); (3) sleep duration (component 3); (4) habitual sleep activity (component 4); (5) sleep disturbances (component 5); (6) use of sleep medication (component 6); (7) daytime dysfunction (component 7). A high total score from the instrument reflects poor quality of sleep. The instrument does not indicate whether or not there is a sleep disturbance or how widespread the sleep disturbances are, if present. However, a total PSQI score of = 5 has been determined to be poor sleep quality.	Change of the scores obtained in the questionnaires at 2 months.
Secondary	Fatigue Severity Scale	The FSS, which was published in 1989 by Krupp, has nine items. For each question, the patient is asked to choose a number from 1 to 7 that indicates how much the patient agrees with each statement, where 1 indicates strong disagreement and 7 indicates strong agreement. A score of 4 or higher generally indicates severe fatigue.	Change of the scores obtained in the questionnaires at 2 months.