Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04942431

REBIRTH Active School 2.0 . a School Based Physical Activity Program

Rebirth active SCHOOL 2.0 is a physical activity intervention program and about to be realised at 40 primary schools in Lower Saxony Germany.

Half of all schools will be assigned to the intervention program or to wait for one year before starting with the movement program. After one and two years, the follow up will take place. After completing baseline examinations (i.e. physical and cognitive functions, physical activity questionnaires) the intervention program will start for one year.

The intervention program is going to be designed with the goal of implementing physical activity of 60 minutes per day. For the main module of movement impulses, the pupils will perform a 5-minute exercise in every lesson, realised by the teachers.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Primary School Children

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hanover Medical School

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First and second grade pupils at primary schools (District Hannover/Wolfsburg/Helmstedt/Gifhorn/Hildesheim; Lower-Saxony, Germany),

Exclusion criteria

  • none, if no medical contraindications against intensive physical activity/tests excist.

Treatment and study plan

Rebirth active SCHOOL 2.0 movement program

Behavioral

60 Minutes of physical activity per day integrated in every school-day.

Primary outcomes

  1. Change in Endurance capacity via Six-Minutes Running test

    Time frame: At baseline, after 1 and 2 years.

    Completed meters in Six-Minutes running test: German Motor Test 6-18 (Bös, 2009):

  2. Change in Sprint velocity via 20 meter sprint

    Time frame: At baseline, after 1 and 2 years.

    20 meter sprint test measured in seconds: German Motor Test 6-18 (Bös, 2009). Scoring the best attempt out of two.

  3. Change in Strength tests via 40 seconds of Push ups and sit ups

    Time frame: At baseline, after 1 and 2 years.

    Number of repetitions in 40 seconds of Push ups and sit ups: German Motor Test 6-18 (Bös, 2009)

  4. Change in Coordination exercise: via 60 seconds Single leg stand

    Time frame: At baseline, after 1 and 2 years.

    Ground contacts in 60 seconds Single leg stand: German Motor Test 6-18 (Bös, 2009)

Secondary outcomes

  1. Peripheral blood pressure

    Time frame: At baseline, after 1 and 2 years.

    Peripheral blood pressure will be measured in a seated position after a resting period of 5 minutes. We will use the oscillometric Dinamap device (Dinamap v150; Fa. GE Medical Systems, Chicago, Illinois, USA). Three measurements will be taken on the right and on the left arm. Between each measurement will be a 1 minute resting period. The Median of the left and the right arm is used for further calculations. If the Median is above the 90th percentile three measurements will be taken again by the investigator using the auscultatory method.

  2. Central blood pressure

    Time frame: At baseline, after 1 and 2 years.

    Central blood pressure will be measured in a spinal position using an oscillometric device, the Mobil-O-Graph (I.E.M. GmbH). The cuff size must be chosen accordingly to the arm size. After a resting period of 5 minutes 3 measurements will be taken on the right arm. Between each measurement will be 30 seconds. The mean of the 3 measurements will be used for further calculations.

  3. Arterial pulse wave

    Time frame: At baseline, after 1 and 2 years.

    Arterial pulse wave will be measured in a spinal position using the Vicorder. The patient should rest for 5 minutes before the start of the measurement. The thigh cuff will be placed around the patient's upper right thigh as high as possible. The cuff around the neck has to be placed over the right carotid artery. The investigator has to measure from the suprasternal notch vertically to the umbilicus and from the umbilicus diagonally to the mid of the thigh cuff. The length will be added up and the measurement from the suprasternal notch to the cuff around the neck will be subtracted. The length will be used for calculating the arterial pulse wave velocity. Three measurements will be taken with each having 10 consecutive waveforms with similar shape and size. The mean of the 3 measurements will be used for further calculations.

  4. Quality of life via KidKindl

    Time frame: At baseline, after 1 and 2 years.

    The quality of life will be assessed applying the KidKindl questionnaire (6 questions, Likert-Skale, 24 Items, Scale 0-100) in a 1 to 1 interview. Higher scores mean a better outcome.

  5. Physical activity questionnaire

    Time frame: At baseline, after 1 and 2 years.

    The physical activity will be assessed applying the physical activity questionnaire according to the KIGGS Study (MoMo Modul) in a 1 to 1 interview.

  6. BMI (kg/m^2)

    Time frame: At baseline, after 1 and 2 years.

    weight and height will be combined to report BMI in kg/m^2

  7. Body Fat Mass (kg), (%)

    Time frame: At baseline, after 1 and 2 years.

    Body Fat Mass will be measured in kilogram and percent via Body Impedance Measurement using the InBody 230.

  8. Skeletal Muscle Mass (kg)

    Time frame: At baseline, after 1 and 2 years.

    Skeletal Muscle Mass will be measured in kilogram via Body Impedance Measurement using the InBody 230.

  9. Fat Free Mass (kg)

    Time frame: At baseline, after 1 and 2 years.

    Fat Free Mass will be measured in kilogram via Body Impedance Measurement using the InBody 230.

  10. Body height (cm)

    Time frame: At baseline, after 1 and 2 years.

    Measured in cm

  11. Waist - Hip circumferences (cm)

    Time frame: At baseline, after 1 and 2 years.

    Measured in cm

  12. Concentration ability

    Time frame: At baseline, after 1 and 2 years.

    The concentration ability will be assessed via the CCTT (children colour trail test) using the time required to perform the test and mistakes made in the test. Percentiles can be used for the comparison with peers.

  13. Pediatric Quality of Life

    Time frame: At baseline, after 1 and 2 years.

    Quality of Life will be assessed via PedsQL (Quality of Life via PedsQL), 6 Questions in a 1 to 1 interview. Higher scores refect a higher quality of life.

  14. Cognitive function

    Time frame: At baseline, after 1 and 2 years.

    Cognitive function (Happiness/Trust/Learning) will be assessed via questionnaire in a 1 to 1 interview (Scale 0-100, a higher score means a better outcome)

  15. Dental health Status

    Time frame: At baseline, after 1 and 2 years.

    Dental health status will be assessed via questionnaire (6 Questions) in a 1 to 1 interview.

  16. Program adherence

    Time frame: Whole intervention period (24 month)

    Program adherence will be assessed via Protocols by documenting the number of physical activity impulses at each participating school (minutes per day).

  17. Phosphat (mmol/l)

    Time frame: At baseline, after 1 and 2 years.

    Phosphat in mmol/l will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  18. CysC; Cystatin C (mg/l)

    Time frame: At baseline, after 1 and 2 years.

    CysC in mg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  19. Urea (mg/dl)

    Time frame: At baseline, after 1 and 2 years.

    Urea in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  20. Kreatinin (mg/dl)

    Time frame: At baseline, after 1 and 2 years.

    Kreatinin in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  21. Uric acid (mg/dl)

    Time frame: At baseline, after 1 and 2 years.

    Uric acid in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  22. GPT; Glutamate pyruvate transaminase (U/l)

    Time frame: At baseline, after 1 and 2 years.

    GPT in U/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  23. Bilirubin (mg/dl)

    Time frame: At baseline, after 1 and 2 years.

    Bilirubin in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  24. Triglyceride (mg/dl)

    Time frame: At baseline, after 1 and 2 years.

    Triglyceride in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  25. Albumin (g/l)

    Time frame: At baseline, after 1 and 2 years.

    Albumin in g/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  26. CRPhs; High-sensitivity C-reactive protein (mg/l)

    Time frame: At baseline, after 1 and 2 years.

    CRPhs in mg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  27. HbA1c (%)

    Time frame: At baseline, after 1 and 2 years.

    HbA1c in % will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  28. Cortisol (µg/l),

    Time frame: At baseline, after 1 and 2 years.

    Cortisol in µg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  29. Insulin (U/l )

    Time frame: At baseline, after 1 and 2 years.

    Insulin in U/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  30. Leukozyten (Tsd/µl)

    Time frame: At baseline, after 1 and 2 years.

    Leukozyten in Tsd/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  31. Erythrozyten (Mio/µl)

    Time frame: At baseline, after 1 and 2 years.

    Erythrozyten in Mio/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  32. Hb; Hemoglobin (g/dl),

    Time frame: At baseline, after 1 and 2 years.

    Hb in g/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  33. Hkt;hematocrit (%)

    Time frame: At baseline, after 1 and 2 years.

    Hkt in %, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  34. MCHC ean corpuscular hemoglobin concentration (g/dl)

    Time frame: At baseline, after 1 and 2 years.

    MCHC in g/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  35. Thrombozyten (Tsd/µl)

    Time frame: At baseline, after 1 and 2 years.

    Thrombozyten in Tsd/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  36. Natrium (mmol/l)

    Time frame: At baseline, after 1 and 2 years.

    Natrium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  37. Kalium (mmol/l)

    Time frame: At baseline, after 1 and 2 years.

    Kalium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  38. Calcium (mmol/l)

    Time frame: At baseline, after 1 and 2 years.

    Calcium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  39. Cholesterin (mg/dl)

    Time frame: At baseline, after 1 and 2 years.

    Cholesterin in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  40. HDL; High Density Lipoprotein (mg/dl)

    Time frame: At baseline, after 1 and 2 years.

    HDL in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  41. LDL; Low Density Lipoprotein (mg/dl)

    Time frame: At baseline, after 1 and 2 years.

    LDL in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  42. MCV; mean corpuscular volume (fl)

    Time frame: At baseline, after 1 and 2 years.

    MCV in fl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  43. MCH; mean corpuscular hemoglobin (pg)

    Time frame: At baseline, after 1 and 2 years.

    MCH in pg, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.

  44. Urine Analysis

    Time frame: At baseline, after 1 and 2 years.

    Urine will be taken from the midstream urine. The children will take the sample with the help of the parents at home. The lab will measure the following urin parameters: Protein, Albumin (mg/dl), Kreatinin (g/l), Osmolarität (mOsm/kg)

  45. Salvia Analysis

    Time frame: At baseline, after 1 and 2 years.

    salvia

  46. Steps per day

    Time frame: At baseline, after 1 and 2 years.

    Steps per day will be assessed via Garmin Vivofit 4 devices.

  47. Hours of sleep

    Time frame: At baseline, after 1 and 2 years.

    Hours of sleep will be assessed via Garmin Vivofit 4 devices.

  48. Metabolic Equivalent

    Time frame: At baseline, after 1 and 2 years.

    Metabolic Equivalent (MET) (1 kcal/kg/hour) will be assessed applying Garmin Vivofit 4 devices.

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

REBIRTH Active School 2.0. Impact of a School-based Physical Activity Program on the Long-term Improvement of Student Health.

Acronym: RAS2

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2021
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.