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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy; Fatigue; Sleep; Stress, Physiological; Activity, Motor
• Intervention / Treatment: Other: Exercise; Other: Vagus Nerve Stimulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Turkeli
    • Sinop, Turkeli, Turkey, 57900
      • Sefa Haktan Hatık

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise group; 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.	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.
EXPERIMENTAL: Vagus group; Vagus therapy will be applied to Group 2 for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.	Other: 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.
NO_INTERVENTION: Control group; Control group will be followed as a control group and no application will be made.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chest circumference measurement	İt 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)
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.
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.
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.

Collaborators and Investigators

• Sponsor: Sinop University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 30, 2021
• Primary Completion (ANTICIPATED): June 7, 2021
• Study Completion (ANTICIPATED): July 7, 2021

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (ACTUAL): April 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 17, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Exercise; Autonomic nervous system; Vagus therapy
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: VNS002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No