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

Primary Purpose

Healthy, Activity, Motor, Sleep

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise
Vagus Nerve Stimulation
Sponsored by
Sinop University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Healthy focused on measuring Exercise, Vagus therapy, Autonomic nervous system

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Sefa Haktan Hatık

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Exercise group

Vagus group

Control group

Arm Description

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 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.

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

Outcomes

Primary Outcome Measures

Evaluation of autonomous parameters
Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.

Secondary Outcome Measures

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).
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.
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.
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.

Full Information

First Posted
March 26, 2021
Last Updated
April 17, 2021
Sponsor
Sinop University
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1. Study Identification

Unique Protocol Identification Number
NCT04832347
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2021 (Anticipated)
Primary Completion Date
June 7, 2021 (Anticipated)
Study Completion Date
July 7, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sinop University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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; Evaluation of autonomous parameters; It was planned to measure pulse and heart rate variability. Chest circumference measurement 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Activity, Motor, Sleep, Stress, Physiological, Fatigue
Keywords
Exercise, Vagus therapy, Autonomic nervous system

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
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.
Arm Title
Vagus group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will be followed as a control group and no application will be made.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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
Intervention Name(s)
Vagus Nerve Stimulation
Intervention Description
Vagus therapy will be applied for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.
Primary Outcome Measure Information:
Title
Evaluation of autonomous parameters
Description
Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.
Time Frame
Change from Systolic / diastolic blood pressure (mmHg) at 2 months.
Secondary Outcome Measure Information:
Title
Chest circumference measurement
Description
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).
Time Frame
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)
Title
Perceived Stress Scale
Description
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.
Time Frame
Change of the scores obtained in the questionnaires at 2 months.
Title
Pitsburg Sleep Quality Scale
Description
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.
Time Frame
Change of the scores obtained in the questionnaires at 2 months.
Title
Fatigue Severity Scale
Description
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.
Time Frame
Change of the scores obtained in the questionnaires at 2 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Sefa Haktan Hatık
City
Sinop
State/Province
Turkeli
ZIP/Postal Code
57900
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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