YogaNCT02741973
Yoga in School Sports - a Pilot Study in Germany
A study testing Yoga and School sport in people with Yoga and Stress, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for school sports to evaluate potential effects in stress reduction and concomitant psychological parameters. Read more about this study
- Who is it for?
- Ages 17 to 27 years
- What is being tested?
- Yoga and School sport
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2016to Dec 2016
- 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 17 to 27 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Students of Berlin Oberstufenzentrum (OSZ) aged 17-27 years
- Written consent (with parents at underage (17 years)
Who cannot join
- Severe chronic or acute diseases
- Pregnancy or lactation
- Immobility or restriction for gymnastic exercises because of orthopedic, neurological or other medical reasons
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109
About this study
Official title: Yoga in School Sports - a Non-randomized Controlled Pilot Study in Germany
The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for school sports to evaluate potential effects in stress reduction and concomitant psychological parameters.
- Being tested
- Yoga, School sport
- Keywords
- Yoga, Stress, Adolescents, School, Children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
School sportOther
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | Students have 10 weeks yoga instead of school sport. Receives: Other: Yoga |
| School sport | Active comparator | Students have 10 weeks regular school sport. Receives: Other: School sport |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen Perceived Stress Scale (CPS)
Measured: Change in CPS from Baseline to 10 weeks
Secondary outcomes (8)
Cohen Perceived Stress Scale (CPS)
Measured: Change in CPS from Baseline to 6 months
WHO-5 questionaire (quality of life)
Measured: Baseline, 10 weeks, 6 months
Hospital Anxiety and Depression (HADS)
Measured: Baseline, 10 weeks, 6 months
Profile of Mood States (POMS)
Measured: Baseline, 10 weeks, 6 months
Visual analogue scales (VAS) for general pain, headache, shoulder and neck tension, fatigue, sleep quality
Measured: Baseline, 10 weeks, 6 months
D2 Test of Attention
The d2 Test of Attention is a neuropsychological paper-and-pencil test of selective and sustained attention. Participants have to cross out any letter "d" with two marks around above it or below it in any order. Surrounding distractors are similar to the target stimulus, e.g. a "p" with two marks.
Measured: Baseline, 10 weeks, 6 months
Yoga Self-Efficacy Scale
Measured: Baseline, 10 weeks, 6 months
Overall assessment of efficacy and tolerability (Likert scales)
Measured: Baseline, 10 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741973
- Sponsor's protocol ID
- SchoolYoga
- Status last verified
- Feb 2018
- First submitted
- 23 Mar 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga in School Sports - a Non-randomized Controlled Pilot Study in Germany
- ClinicalTrials.gov ID
- NCT02741973
- Acronym / sponsor ID
- SchoolYoga
- Keywords
- Yoga, Stress, Adolescents, School, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Apr 2016 (estimated)
- 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.
The aim of this trial is a first evaluation of the effectiveness of yoga as alternative for school sports to evaluate potential effects in stress reduction and concomitant psychological parameters.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: YogaStudents have 10 weeks yoga instead of school sport. |
| School sport | Active comparator | Other: School sportStudents have 10 weeks regular school sport. |
Who may qualify
- Ages
- 17 to 27 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Students of Berlin Oberstufenzentrum (OSZ) aged 17-27 years
- Written consent (with parents at underage (17 years)
Key exclusion criteria (4 listed)
- Severe chronic or acute diseases
- Pregnancy or lactation
- Immobility or restriction for gymnastic exercises because of orthopedic, neurological or other medical reasons
- Participation in another study
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 |
|---|---|---|
| Yoga | Other | Yoga |
| School sport | Other | School sport |
Primary outcome
Cohen Perceived Stress Scale (CPS)
Time frame: Change in CPS from Baseline to 10 weeks
8 secondary outcomes
Cohen Perceived Stress Scale (CPS)
Time frame: Change in CPS from Baseline to 6 months
WHO-5 questionaire (quality of life)
Time frame: Baseline, 10 weeks, 6 months
Hospital Anxiety and Depression (HADS)
Time frame: Baseline, 10 weeks, 6 months
Profile of Mood States (POMS)
Time frame: Baseline, 10 weeks, 6 months
Visual analogue scales (VAS) for general pain, headache, shoulder and neck tension, fatigue, sleep quality
Time frame: Baseline, 10 weeks, 6 months
D2 Test of Attention
Time frame: Baseline, 10 weeks, 6 months
Yoga Self-Efficacy Scale
Time frame: Baseline, 10 weeks, 6 months
Overall assessment of efficacy and tolerability (Likert scales)
Time frame: Baseline, 10 weeks, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
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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 Yoga and School sport in people with Yoga and Stress, run by Charite University, Berlin, Germany at 1 site in Germany.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Feb 2018. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cohen Perceived Stress Scale (CPS) (time frame: Change in CPS from Baseline to 10 weeks). 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 19 Feb 2018.