Clinical trial NCT04832347: Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals
Official title: Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Activity, Motor
Sleep
Stress, Physiological
Fatigue
Keywords: Exercise
Vagus therapy
Autonomic nervous system
Lead sponsor: Sinop University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of autonomous parameters
timeFrame: Change from Systolic / diastolic blood pressure (mmHg) at 2 months.
Secondary outcomes:
measure: Chest circumference measurement
timeFrame: 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)
measure: Perceived Stress Scale
timeFrame: Change of the scores obtained in the questionnaires at 2 months.
measure: Pitsburg Sleep Quality Scale
timeFrame: Change of the scores obtained in the questionnaires at 2 months.
measure: Fatigue Severity Scale
timeFrame: Change of the scores obtained in the questionnaires at 2 months.
Other outcomes:
Locations:
city: Sinop
country: Turkey
facility: Sefa Haktan Hatık
state: Turkeli
Study officials:
References: