Healthy Clinical Trial
Official title:
Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals
Verified date | April 2021 |
Source | Sinop University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 45 |
Est. completion date | July 7, 2021 |
Est. primary completion date | June 7, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Sefa Haktan Hatik | Sinop | Turkeli |
Lead Sponsor | Collaborator |
---|---|
Sinop University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Chest circumference measurement | It 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) | |
Secondary | 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. | |
Secondary | 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. | |
Secondary | 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. |
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