An interventional study of Exercise and Vagus Nerve Stimulation in Healthy, Activity, Motor and Sleep, sponsored by Sinop University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-20.
Sponsored by Sinop University · Not applicable, Interventional, and Supportive care
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.
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;
All individuals were planned to be evaluated before, after and 1 month after the application.
1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.
This study's planned enrollment of 45 is below the median of 54 across 1,440 interventional studies indexed under Fatigue.
Browse Fatigue studies →Sinop University is the lead sponsor of 30 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Control group will be followed as a control group and no application will be made.
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 for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.
Evaluation of autonomous parameters
Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.
Time frame: Change from Systolic / diastolic blood pressure (mmHg) at 2 months.
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).
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Change of the scores obtained in the questionnaires at 2 months.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Sinop University