跳至主要内容
临床试验/NCT04942431
NCT04942431进行中(未招募)不适用

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

Hannover Medical School2 个研究点 分布在 1 个国家目标入组 1,245 人开始时间: 2021年6月28日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,245
试验地点
2
主要终点
Change in Coordination exercise: via 60 seconds Single leg stand

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Change in Coordination exercise: via 60 seconds Single leg stand

时间窗: At baseline, after 1 and 2 years.

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

Change in Endurance capacity via Six-Minutes Running test

时间窗: At baseline, after 1 and 2 years.

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

Change in Sprint velocity via 20 meter sprint

时间窗: 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.

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

时间窗: 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)

次要结局

  • Salvia Analysis(At baseline, after 1 and 2 years.)
  • Dental health Status(At baseline, after 1 and 2 years.)
  • Peripheral blood pressure(At baseline, after 1 and 2 years.)
  • Body height (cm)(At baseline, after 1 and 2 years.)
  • Program adherence(Whole intervention period (24 month))
  • CysC; Cystatin C (mg/l)(At baseline, after 1 and 2 years.)
  • CRPhs; High-sensitivity C-reactive protein (mg/l)(At baseline, after 1 and 2 years.)
  • Quality of life via KidKindl(At baseline, after 1 and 2 years.)
  • BMI (kg/m^2)(At baseline, after 1 and 2 years.)
  • Arterial pulse wave(At baseline, after 1 and 2 years.)
  • Physical activity questionnaire(At baseline, after 1 and 2 years.)
  • Fat Free Mass (kg)(At baseline, after 1 and 2 years.)
  • Central blood pressure(At baseline, after 1 and 2 years.)
  • Concentration ability(At baseline, after 1 and 2 years.)
  • Urea (mg/dl)(At baseline, after 1 and 2 years.)
  • Triglyceride (mg/dl)(At baseline, after 1 and 2 years.)
  • Cortisol (µg/l),(At baseline, after 1 and 2 years.)
  • Calcium (mmol/l)(At baseline, after 1 and 2 years.)
  • Body Fat Mass (kg), (%)(At baseline, after 1 and 2 years.)
  • Skeletal Muscle Mass (kg)(At baseline, after 1 and 2 years.)
  • Waist - Hip circumferences (cm)(At baseline, after 1 and 2 years.)
  • Pediatric Quality of Life(At baseline, after 1 and 2 years.)
  • Cognitive function(At baseline, after 1 and 2 years.)
  • Phosphat (mmol/l)(At baseline, after 1 and 2 years.)
  • Uric acid (mg/dl)(At baseline, after 1 and 2 years.)
  • Albumin (g/l)(At baseline, after 1 and 2 years.)
  • HbA1c (%)(At baseline, after 1 and 2 years.)
  • Erythrozyten (Mio/µl)(At baseline, after 1 and 2 years.)
  • Hkt;hematocrit (%)(At baseline, after 1 and 2 years.)
  • Natrium (mmol/l)(At baseline, after 1 and 2 years.)
  • MCV; mean corpuscular volume (fl)(At baseline, after 1 and 2 years.)
  • Urine Analysis(At baseline, after 1 and 2 years.)
  • Kreatinin (mg/dl)(At baseline, after 1 and 2 years.)
  • Leukozyten (Tsd/µl)(At baseline, after 1 and 2 years.)
  • Thrombozyten (Tsd/µl)(At baseline, after 1 and 2 years.)
  • Kalium (mmol/l)(At baseline, after 1 and 2 years.)
  • LDL; Low Density Lipoprotein (mg/dl)(At baseline, after 1 and 2 years.)
  • Hours of sleep(At baseline, after 1 and 2 years.)
  • GPT; Glutamate pyruvate transaminase (U/l)(At baseline, after 1 and 2 years.)
  • Bilirubin (mg/dl)(At baseline, after 1 and 2 years.)
  • Insulin (U/l )(At baseline, after 1 and 2 years.)
  • Hb; Hemoglobin (g/dl),(At baseline, after 1 and 2 years.)
  • MCHC ean corpuscular hemoglobin concentration (g/dl)(At baseline, after 1 and 2 years.)
  • Cholesterin (mg/dl)(At baseline, after 1 and 2 years.)
  • HDL; High Density Lipoprotein (mg/dl)(At baseline, after 1 and 2 years.)
  • MCH; mean corpuscular hemoglobin (pg)(At baseline, after 1 and 2 years.)
  • Steps per day(At baseline, after 1 and 2 years.)
  • Metabolic Equivalent(At baseline, after 1 and 2 years.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Celine Braun

Institute for Sports Medicine

Hannover Medical School

研究点 (2)

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