Yoga in School Sports - a Pilot Study in Germany

February 16, 2018 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 27 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Students of Berlin Oberstufenzentrum (OSZ) aged 17-27 years
  • Written consent (with parents at underage (17 years)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Yoga
Students have 10 weeks yoga instead of school sport.
Other: Yoga
ACTIVE_COMPARATOR: School sport
Students have 10 weeks regular school sport.
Other: School sport

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cohen Perceived Stress Scale (CPS)
Time Frame: Change in CPS from Baseline to 10 weeks
Change in CPS from Baseline to 10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen Perceived Stress Scale (CPS)
Time Frame: Change in CPS from Baseline to 6 months
Change in CPS from Baseline to 6 months
WHO-5 questionaire (quality of life)
Time Frame: Baseline, 10 weeks, 6 months
Baseline, 10 weeks, 6 months
Hospital Anxiety and Depression (HADS)
Time Frame: Baseline, 10 weeks, 6 months
Baseline, 10 weeks, 6 months
Profile of Mood States (POMS)
Time Frame: Baseline, 10 weeks, 6 months
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
Baseline, 10 weeks, 6 months
D2 Test of Attention
Time Frame: Baseline, 10 weeks, 6 months
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.
Baseline, 10 weeks, 6 months
Yoga Self-Efficacy Scale
Time Frame: Baseline, 10 weeks, 6 months
Baseline, 10 weeks, 6 months
Overall assessment of efficacy and tolerability (Likert scales)
Time Frame: Baseline, 10 weeks, 6 months
Baseline, 10 weeks, 6 months

Other Outcome Measures

Outcome Measure
Time Frame
Heart rate variability
Time Frame: Baseline, 10 weeks, 6 months
Baseline, 10 weeks, 6 months
Qualitative interviews in focus groups
Time Frame: 5 weeks, 10 weeks
5 weeks, 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

March 23, 2016

First Submitted That Met QC Criteria

April 13, 2016

First Posted (ESTIMATE)

April 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 19, 2018

Last Update Submitted That Met QC Criteria

February 16, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SchoolYoga

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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