Clinical trial NCT04942431: REBIRTH Active School 2.0 . a School Based Physical Activity Program
Official title: REBIRTH Active School 2.0. Impact of a School-based Physical Activity Program on the Long-term Improvement of Student Health.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Primary School Children
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 1245
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Endurance capacity via Six-Minutes Running test
timeFrame: At baseline, after 1 and 2 years.
measure: Change in Sprint velocity via 20 meter sprint
timeFrame: At baseline, after 1 and 2 years.
measure: Change in Strength tests via 40 seconds of Push ups and sit ups
timeFrame: At baseline, after 1 and 2 years.
measure: Change in Coordination exercise: via 60 seconds Single leg stand
timeFrame: At baseline, after 1 and 2 years.
Secondary outcomes:
measure: Peripheral blood pressure
timeFrame: At baseline, after 1 and 2 years.
measure: Central blood pressure
timeFrame: At baseline, after 1 and 2 years.
measure: Arterial pulse wave
timeFrame: At baseline, after 1 and 2 years.
measure: Quality of life via KidKindl
timeFrame: At baseline, after 1 and 2 years.
measure: Physical activity questionnaire
timeFrame: At baseline, after 1 and 2 years.
measure: BMI (kg/m^2)
timeFrame: At baseline, after 1 and 2 years.
measure: Body Fat Mass (kg), (%)
timeFrame: At baseline, after 1 and 2 years.
measure: Skeletal Muscle Mass (kg)
timeFrame: At baseline, after 1 and 2 years.
measure: Fat Free Mass (kg)
timeFrame: At baseline, after 1 and 2 years.
measure: Body height (cm)
timeFrame: At baseline, after 1 and 2 years.
measure: Waist - Hip circumferences (cm)
timeFrame: At baseline, after 1 and 2 years.
measure: Concentration ability
timeFrame: At baseline, after 1 and 2 years.
measure: Pediatric Quality of Life
timeFrame: At baseline, after 1 and 2 years.
measure: Cognitive function
timeFrame: At baseline, after 1 and 2 years.
measure: Dental health Status
timeFrame: At baseline, after 1 and 2 years.
measure: Program adherence
timeFrame: Whole intervention period (24 month)
measure: Phosphat (mmol/l)
timeFrame: At baseline, after 1 and 2 years.
measure: CysC; Cystatin C (mg/l)
timeFrame: At baseline, after 1 and 2 years.
measure: Urea (mg/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: Kreatinin (mg/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: Uric acid (mg/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: GPT; Glutamate pyruvate transaminase (U/l)
timeFrame: At baseline, after 1 and 2 years.
measure: Bilirubin (mg/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: Triglyceride (mg/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: Albumin (g/l)
timeFrame: At baseline, after 1 and 2 years.
measure: CRPhs; High-sensitivity C-reactive protein (mg/l)
timeFrame: At baseline, after 1 and 2 years.
measure: HbA1c (%)
timeFrame: At baseline, after 1 and 2 years.
measure: Cortisol (µg/l),
timeFrame: At baseline, after 1 and 2 years.
measure: Insulin (U/l )
timeFrame: At baseline, after 1 and 2 years.
measure: Leukozyten (Tsd/µl)
timeFrame: At baseline, after 1 and 2 years.
measure: Erythrozyten (Mio/µl)
timeFrame: At baseline, after 1 and 2 years.
measure: Hb; Hemoglobin (g/dl),
timeFrame: At baseline, after 1 and 2 years.
measure: Hkt;hematocrit (%)
timeFrame: At baseline, after 1 and 2 years.
measure: MCHC ean corpuscular hemoglobin concentration (g/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: Thrombozyten (Tsd/µl)
timeFrame: At baseline, after 1 and 2 years.
measure: Natrium (mmol/l)
timeFrame: At baseline, after 1 and 2 years.
measure: Kalium (mmol/l)
timeFrame: At baseline, after 1 and 2 years.
measure: Calcium (mmol/l)
timeFrame: At baseline, after 1 and 2 years.
measure: Cholesterin (mg/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: HDL; High Density Lipoprotein (mg/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: LDL; Low Density Lipoprotein (mg/dl)
timeFrame: At baseline, after 1 and 2 years.
measure: MCV; mean corpuscular volume (fl)
timeFrame: At baseline, after 1 and 2 years.
measure: MCH; mean corpuscular hemoglobin (pg)
timeFrame: At baseline, after 1 and 2 years.
measure: Urine Analysis
timeFrame: At baseline, after 1 and 2 years.
measure: Salvia Analysis
timeFrame: At baseline, after 1 and 2 years.
measure: Steps per day
timeFrame: At baseline, after 1 and 2 years.
measure: Hours of sleep
timeFrame: At baseline, after 1 and 2 years.
measure: Metabolic Equivalent
timeFrame: At baseline, after 1 and 2 years.
Other outcomes:
Locations:
city: Hanover
country: Germany
facility: Hanover Medical School
state: Lower Saxony
Study officials:
affiliation: Hannover Medical School, Hannover Lower Saxony, Germany, 30625
name: Uwe Tegtbur, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical School Hannover Lower Saxony, Germany, 30625
name: Anette Melk, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: