HealthyNCT04832347
Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals
A study testing Exercise and Vagus Nerve Stimulation in people with Healthy and Activity, Motor, run by Sinop University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Activity, Motor, Sleep
- What is being tested?
- Exercise and Vagus Nerve Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2021to 7 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- Individuals not wanting to continue working.
- Individuals having disability during the work process
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy, Activity, Motor, Sleep, Stress, Physiological, Fatigue
- Being tested
- Exercise, Vagus Nerve Stimulation
- Keywords
- Exercise, Vagus therapy, Autonomic nervous system
- Medical subject headings
- Motor Activity, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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 Nerve StimulationOther
Vagus therapy will be applied for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 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. Receives: Other: Exercise |
| Vagus group | Experimental | 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. Receives: Other: Vagus Nerve Stimulation |
| Control group | No intervention | Control group will be followed as a control group and no application will be made. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of autonomous parameters
Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.
Measured: Change from Systolic / diastolic blood pressure (mmHg) at 2 months.
Secondary outcomes (4)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change of the scores obtained in the questionnaires at 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start30 Apr 2021 (estimated)
- Primary completion7 Jun 2021 (estimated)
- Study completion7 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinop University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SEFA HAKTAN HATIK, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832347
- Sponsor's protocol ID
- VNS002
- Status last verified
- Apr 2021
- First submitted
- 26 Mar 2021
- Last updated
- 20 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Exercise and Vagus Therapy in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04832347
- Acronym / sponsor ID
- VNS002
- Conditions
- Healthy, Activity, Motor, Sleep, Stress, Physiological, Fatigue
- Keywords
- Exercise, Vagus therapy, Autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Sinop UniversityUniversity, hospital or other
- Study start
- 30 Apr 2021 (estimated)
- Primary completion
- 7 Jun 2021 (estimated)
- Study completion
- 7 Jul 2021 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: ExerciseExercise 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 | Experimental | Other: Vagus Nerve StimulationVagus 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 | No intervention | –Control group will be followed as a control group and no application will be made. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- Individuals not wanting to continue working.
- Individuals having disability during the work process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseExercise 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 group |
| Vagus Nerve StimulationVagus therapy will be applied for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes. | Other | Vagus group |
Primary outcome
Evaluation of autonomous parameters
Time frame: Change from Systolic / diastolic blood pressure (mmHg) at 2 months.
Systolic / diastolic blood pressure (mmHg) will be measured with the Braun sphygmomanometer.
4 secondary outcomes
Chest circumference measurement
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
Time frame: Change of the scores obtained in the questionnaires at 2 months.
Pitsburg Sleep Quality Scale
Time frame: Change of the scores obtained in the questionnaires at 2 months.
Fatigue Severity Scale
Time frame: Change of the scores obtained in the questionnaires at 2 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Vagus Nerve Stimulation in people with Healthy and Activity, Motor, run by Sinop University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of autonomous parameters (time frame: Change from Systolic / diastolic blood pressure (mmHg) at 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.