NCT02741973

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

9 months

First QC Date

March 23, 2016

Last Update Submit

February 16, 2018

Conditions

YogaStress

Keywords

YogaStressAdolescentsSchoolChildren

Outcome Measures

Primary Outcomes (1)

  • Cohen Perceived Stress Scale (CPS)

    Change in CPS from Baseline to 10 weeks

Secondary Outcomes (8)

  • Cohen Perceived Stress Scale (CPS)

    Change in CPS from Baseline to 6 months

  • WHO-5 questionaire (quality of life)

    Baseline, 10 weeks, 6 months

  • Hospital Anxiety and Depression (HADS)

    Baseline, 10 weeks, 6 months

  • Profile of Mood States (POMS)

    Baseline, 10 weeks, 6 months

  • Visual analogue scales (VAS) for general pain, headache, shoulder and neck tension, fatigue, sleep quality

    Baseline, 10 weeks, 6 months

  • +3 more secondary outcomes

Other Outcomes (2)

  • Heart rate variability

    Baseline, 10 weeks, 6 months

  • Qualitative interviews in focus groups

    5 weeks, 10 weeks

Study Arms (2)

Yoga

EXPERIMENTAL

Students have 10 weeks yoga instead of school sport.

Other: Yoga

School sport

ACTIVE COMPARATOR

Students have 10 weeks regular school sport.

Other: School sport

Interventions

YogaOTHER
Yoga
School sportOTHER
School sport

Eligibility Criteria

Age17 Years - 27 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

Location

MeSH Terms

Interventions

Yoga

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Andreas Michalsen, Prof. Dr.

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 18, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 19, 2018

Record last verified: 2018-02

Locations

DE(1)