Yoga in school sports improves functioning of autonomic nervous system in young adults: A non-randomized controlled pilot study

Background Yoga in school is a beneficial tool to promote the good health and well-being of students by changing the way they react to stress. The positive effects of yoga—taught in schools—on children, youth and young adults have been demonstrated in former studies using mostly subjective psychometric data. Aim The present trial aims to evaluate the potential effects of yoga on autonomic regulation in young adults by analyzing heart rate variability (HRV). Methods This study is a non-randomized, explorative, two-arm-pilot study with an active control group. Fourteen healthy young adults took part in a 10-week yoga program (90 min once a week) in school and were compared to a control group of 11 students who participated in conventional school sports (90 min once a week over 10 weeks). 24-hour electrocardiograms (ECGs) were recorded at baseline and following the 10-week intervention. From 20-minute of nocturnal sleep phases, HRV parameters were calculated from linear (time and frequency domain) and nonlinear dynamics (such as symbolic dynamics and Poincaré plot analysis). Analyses of variance (ANOVA) followed by t-tests as post-hoc tests estimating both statistical significance and effect size were used to compare pre-post-intervention for the two groups. Results The statistical analysis of the interaction effects did not reveal a significant group and time interaction for the individual nocturnal HRV indices. Almost all indices revealed medium and large effects regarding the time main effects. The changes in the HRV indices following the intervention were more dramatic for the yoga group than for the control group which is reflected in predominantly higher significances and stronger effect sizes in the yoga group. Conclusion In this explorative pilot trial, an increase of HRV (more parasympathetic dominance and overall higher HRV) after ten weeks of yoga in school in comparison to regular school sports was demonstrated, showing an improved self-regulation of the autonomic nervous system.

1. Title of the study "Yoga in school sports, "Non-randomized controlled pilot study to evaluate the effects of school stressredukction Yoga for students * inside of the Berlin school centers (OSZ) 2. Ethics Commission's application number EA2 / 023/16 3. Decisions of other ethics committees in the same case 4th The study and its objectives; Indication of the hypotheses, separated into primary and secondary hypotheses and clinical parameters (primary and secondary endpoints), based on which the hypotheses are tested The main objective is the scientific monitoring and evaluation of the effects of a 10-week yoga classes as an innovative standard part of OSC physical education on feelings of stress, quality of life and mental perception in Berlin OSZ students * inside compared to a control group that the regular OSZ physical education visited.
Hypothesis: A 10-week yoga classes leads to a reduction of the stress strength and has a positive effect on mental and physical sense as well as the concentration of.

MAIN OUTCOME (not confirmatory):
o Comparison of the groups in the course with regard to the stress intensity using the Cohen Perceived Stress Scale (CPSS) There are exclusively non-invasive surveys using internationally validated questionnaires in German.
how Yoga is personally assessed and evaluated in addition is requested after 5 and 10 weeks at 15 students in the yoga group as part of 45-minute group interview. Which participated in the group interviews pupils * get in as a thank you a bookshelf, a cinema voucher. The offer is made to participate in the interviews for selection before randomization. The focus group interviews are recorded for the qualitative detection in a phonogram and then transcribed and content analysis. takes place at 40 subjects by selecting according randomization the inclusion of a 24 Holter ECG to measure the stress response before the start, after 10 weeks of intervention and 6 months after completion of the study. ethical aspects The study will be conducted in accordance with international guidelines for clinical trials (Declaration of Helsinki, ICH-GCP) and the research ethical framework of sociological accompanying research. 11. Review and consideration of the foreseeable risks and inconveniences of study participation compared with the expected benefits for the participants and future ill persons (benefit-risk assessment) A simple program of yoga was used, so there is no greater risk of injury than conventional school sports is expected. The intervention is not used primarily for the study, but already then re-inserted, but regular part of physical education in the OSZs. The results can contribute generally to an improved evaluation of the benefits of school sports.
The inclusion of a 24 Holter has no disadvantages for the subjects.
In summary, there is a positive benefit-risk assessment. a. to be tested medical benefits for study participants(Individual benefits for individual patients) Participants in both groups will benefit from a potentially active effect through yoga. The yoga group receives yoga classes as part of the school physical education. Benchmarks can include termination of the observation period, free to participate in a content and timing identical yoga class outside of regular school hours at selected Berlin yoga centers (voucher). This results in a foreseeable potential benefits through participation in the study for all subjects. b. to be tested medical benefits for future ill persons(Group benefits) Yoga will prove in the classroom as helpful in maintaining and improving the mental and physical sense, they could yoga exercises in the future in schools applied and benefit other students. c. Risks and burdens to research participants(List All in detail) All surveys are non-invasive. Yoga has no greater risk than conventional school sport and is a safe exercise method in accordance of guided practice (Cramer 2013). Overall there is no serious public health risk from study participation. 12. risk control measures Participants are encouraged any possible adverse events (AEs) to be reported immediately. UE are evaluated by the investigator and investigators and monitored according to the study progress. 13 termination criteria Each UE is judged by the investigator as to its severity and the possible link with the Yoga program. Serious AEs and adverse events must be reported by the investigator within 24 hours by phone, fax or telegram to the head of the clinical trial. Takes the subject's consent back, so the investigator should discontinue the study for him. This is noted on the report cards.
The study can be aborted if it is evident that the study can not meet these requirements. Which includes: -It occur serious protocol violations the report forms to be filled out poorly or fraudulently -legally or ethical rules are not respected -An early departure for reasons mentioned above, is only possible in agreement between investigator and investigators.
If serious UE or serious northwest on or piling up non-serious AEs, the investigator may stop the study in its sole discretion.
14. Number, age and sex of the persons concerned 120 students from Berlin OSZ centers from 17 to 27 years.
15. Biometric planning, indicating the statistical methodology, including the reasons for the falling number. Specify the / the statistician / Statistician This is a descriptive and exploratory analysis without statistical sample size calculation in a non-randomized pilot study.
The following sample sizes are set: patient numbers  Screening patients (n ≈ 120)  included in the study, patients (n = 110)intention to treat  Patients whose data is subjected to statistical analysis (n = 100) -Per Protocol hypotheses: H0: Efficacy of yoga classes in stress reduction = effectiveness of the regular physical education in stress reduction HA: Efficacy of yoga classes in stress reduction ≠ effectiveness of the regular physical education in stress reduction data analysis The primary, not confirmatory, endpoint is the group difference in the course of Cohen Perceived stress scores after 10 weeks.
The above secondary objective parameters are collected at the beginning (baseline), after 10 weeks and after a total of six months.
The baseline is applicable to two times (before and after the Easter holidays) to account for any possible confounders. The second baseline value is used as a covariate in the analysis of covariance. Consultation with Berlin OSZ schools offering yoga as part of physical education curriculum-compliant written consent of participating students (or their parents also in minority). 18. If necessary, .: reason for including and explanation of the therapeutic benefit for people who are underage and / or not capable of giving consent.
Prolonged stress damaging for young people to health behavior can already cause (see above). There have already been positive evidence for stress reduction and improvement of mental and physical health in adolescents. 19 relationship between study participants and study physician / -ärztin (If the study doctor at the same time, the attending physician?) No 20. Declaration on the inclusion of possibly dependent on the sponsor persons -21. Measures that allow for determining whether a study participant in several studies at the same time or before the expiry of a specified period in the previous study teilnimmt.Ist participating in several studies possible?
All subjects are explicitly asked for an otherwise participate in the study and noted that a simultaneous participation in other clinical trials throughout the study period is not possible.

22.
If necessary, .: payment or reimbursement of the study participants Initial message is from study participants to investigators or investigator. This will be reported in writing within 24 hours to the study director and documented in writing.
28 action to safeguard the confidentiality of stored data, documents and, if necessary, samples, demonstration of pseudonymous or anonymous data and samples from study participants (Initials and date of birth as encoding scheme are not allowed!) -description of the separation of medical records, study documentation and assignment of the personal data -Identification of the access rights, including access to Teilnehmeridentifikations-list during and after the execution Studiendurch--Detailed specification of the procedures for transfer, encryption, blocking and deletion (including specifying the network structure and used server optionally used).
-possibly. Access to identifying data for legally authorized auditor (third parties) to earmarked inspect the for needed files.
In the present study, all subjects data in the report forms and the database are identified only by a number subjects. The list of personal data is kept separate from the database and remains within the Charité and the Immanuel Hospital.
29. Declaration on compliance with data protection -assurance that all the information collected about the subscriber study and stored confidential (secret data and patient confidentiality) to be treated.
-assurance that the identifying Data is only accessible to the investigator or authorized by him employees.
-the measures to ensure confidentiality According to the Federal Data Protection Act (Act) § 4 (1). All recovered audio data will only password-protected with the program Winzip to an external media stored and will not be transferred to third parties. In addition, media are kept under lock and key with the appropriate files when not in use to protect against theft and damage. In the transcribed data are completely anonymous all information necessary to enable a conclusion to be volunteers.
-Measures to privacy-friendly way transmission of data that can be produced no personal reference to third parties.
-provide information indicating the opposition and unloading facilities, -measures to ensure the rights of participants.
30. Names and addresses of facilities that are integrated as a study center or laboratory study in the study, and the study director and investigators -Detailed specification involved external Service with details of data access possibility. The establishment has several years of experience in conducting clinical trials and has already carried out numerous clinical studies. These studies were carried out successfully within the given schedule. At the facility experienced staff and adequate facilities and continuous usable modern PC workstations are available in studies. 32. Agreement on access of the investigator / principal investigator / principal investigator, to the data and the principles governing the publication.
-Publications in a form that allow no conclusion on the person.
The data are accessible only through the study leader. The publication takes place regardless of the result in a recognized journal.
33. Details of the financing of the study: Funding source (name and seat) and amount of funding in €.