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

NCT ID: NCT04832347

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-07-07

Brief Summary

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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

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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.

Conditions

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Healthy Activity, Motor Sleep Stress, Physiological Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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 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.

Group Type EXPERIMENTAL

Vagus Nerve Stimulation

Intervention Type OTHER

Vagus therapy will be applied for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.

Control group

Control group will be followed as a control group and no application will be made.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sinop University

OTHER

Sponsor Role lead

Responsible Party

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SEFA HAKTAN HATIK

Lecturer, PT, MSc, PhD(c)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sefa Haktan Hatık

Sinop, Turkeli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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VNS002

Identifier Type: -

Identifier Source: org_study_id

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