Primary School ChildrenRAS2NCT04942431
REBIRTH Active School 2.0 . a School Based Physical Activity Program
A study testing Rebirth active SCHOOL 2.0 movement program in people with Primary School Children, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary School Children
- What is being tested?
- Rebirth active SCHOOL 2.0 movement program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,245 participants
- Where
- 1 siteGermany
- Study dates
- 28 Jun 2021to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First and second grade pupils at primary schools (District Hannover/Wolfsburg/Helmstedt/Gifhorn/Hildesheim; Lower-Saxony, Germany),
Who cannot join
- none, if no medical contraindications against intensive physical activity/tests excist.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: REBIRTH Active School 2.0. Impact of a School-based Physical Activity Program on the Long-term Improvement of Student Health.
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.
- Conditions
- Primary School Children
- Being tested
- Rebirth active SCHOOL 2.0 movement program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebirth active SCHOOL 2.0 movement programBehavioural
60 Minutes of physical activity per day integrated in every school-day.
| Study group | Role | What they receive |
|---|---|---|
| Interventiongroup | Experimental | 60 min per day school based Physical activity program (for one year) Receives: Behavioral: Rebirth active SCHOOL 2.0 movement program |
| Waitinggroup | No intervention | Intervention starts after one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endurance capacity via Six-Minutes Running test
Completed meters in Six-Minutes running test: German Motor Test 6-18 (Bös, 2009):
Measured: At baseline, after 1 and 2 years.
Change in Sprint velocity via 20 meter sprint
20 meter sprint test measured in seconds: German Motor Test 6-18 (Bös, 2009). Scoring the best attempt out of two.
Measured: At baseline, after 1 and 2 years.
Change in Strength tests via 40 seconds of Push ups and sit ups
Number of repetitions in 40 seconds of Push ups and sit ups: German Motor Test 6-18 (Bös, 2009)
Measured: At baseline, after 1 and 2 years.
Change in Coordination exercise: via 60 seconds Single leg stand
Ground contacts in 60 seconds Single leg stand: German Motor Test 6-18 (Bös, 2009)
Measured: At baseline, after 1 and 2 years.
Secondary outcomes (48)
Peripheral blood pressure
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.
Measured: At baseline, after 1 and 2 years.
Central blood pressure
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.
Measured: At baseline, after 1 and 2 years.
Arterial pulse wave
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.
Measured: At baseline, after 1 and 2 years.
Quality of life via KidKindl
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.
Measured: At baseline, after 1 and 2 years.
Physical activity questionnaire
The physical activity will be assessed applying the physical activity questionnaire according to the KIGGS Study (MoMo Modul) in a 1 to 1 interview.
Measured: At baseline, after 1 and 2 years.
BMI (kg/m^2)
weight and height will be combined to report BMI in kg/m^2
Measured: At baseline, after 1 and 2 years.
Body Fat Mass (kg), (%)
Body Fat Mass will be measured in kilogram and percent via Body Impedance Measurement using the InBody 230.
Measured: At baseline, after 1 and 2 years.
Skeletal Muscle Mass (kg)
Skeletal Muscle Mass will be measured in kilogram via Body Impedance Measurement using the InBody 230.
Measured: At baseline, after 1 and 2 years.
Fat Free Mass (kg)
Fat Free Mass will be measured in kilogram via Body Impedance Measurement using the InBody 230.
Measured: At baseline, after 1 and 2 years.
Body height (cm)
Measured in cm
Measured: At baseline, after 1 and 2 years.
Waist - Hip circumferences (cm)
Measured in cm
Measured: At baseline, after 1 and 2 years.
Concentration ability
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.
Measured: At baseline, after 1 and 2 years.
Pediatric Quality of Life
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.
Measured: At baseline, after 1 and 2 years.
Cognitive function
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)
Measured: At baseline, after 1 and 2 years.
Dental health Status
Dental health status will be assessed via questionnaire (6 Questions) in a 1 to 1 interview.
Measured: At baseline, after 1 and 2 years.
Program adherence
Program adherence will be assessed via Protocols by documenting the number of physical activity impulses at each participating school (minutes per day).
Measured: Whole intervention period (24 month)
Phosphat (mmol/l)
Phosphat in mmol/l will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
CysC; Cystatin C (mg/l)
CysC in mg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Urea (mg/dl)
Urea in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Kreatinin (mg/dl)
Kreatinin in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Uric acid (mg/dl)
Uric acid in mg/dl will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
GPT; Glutamate pyruvate transaminase (U/l)
GPT in U/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Bilirubin (mg/dl)
Bilirubin in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Triglyceride (mg/dl)
Triglyceride in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Albumin (g/l)
Albumin in g/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
CRPhs; High-sensitivity C-reactive protein (mg/l)
CRPhs in mg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
HbA1c (%)
HbA1c in % will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Cortisol (µg/l),
Cortisol in µg/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Insulin (U/l )
Insulin in U/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Leukozyten (Tsd/µl)
Leukozyten in Tsd/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Erythrozyten (Mio/µl)
Erythrozyten in Mio/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Hb; Hemoglobin (g/dl),
Hb in g/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Hkt;hematocrit (%)
Hkt in %, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
MCHC ean corpuscular hemoglobin concentration (g/dl)
MCHC in g/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Thrombozyten (Tsd/µl)
Thrombozyten in Tsd/µl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Natrium (mmol/l)
Natrium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Kalium (mmol/l)
Kalium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Calcium (mmol/l)
Calcium in mmol/l, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Cholesterin (mg/dl)
Cholesterin in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
HDL; High Density Lipoprotein (mg/dl)
HDL in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
LDL; Low Density Lipoprotein (mg/dl)
LDL in mg/dl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
MCV; mean corpuscular volume (fl)
MCV in fl, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
MCH; mean corpuscular hemoglobin (pg)
MCH in pg, will be measured via Blood Analysis. Blood will be taken in the morning with a fasting blood test.
Measured: At baseline, after 1 and 2 years.
Urine Analysis
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)
Measured: At baseline, after 1 and 2 years.
Salvia Analysis
salvia
Measured: At baseline, after 1 and 2 years.
Steps per day
Steps per day will be assessed via Garmin Vivofit 4 devices.
Measured: At baseline, after 1 and 2 years.
Hours of sleep
Hours of sleep will be assessed via Garmin Vivofit 4 devices.
Measured: At baseline, after 1 and 2 years.
Metabolic Equivalent
Metabolic Equivalent (MET) (1 kcal/kg/hour) will be assessed applying Garmin Vivofit 4 devices.
Measured: At baseline, after 1 and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start28 Jun 2021
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary School ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celine Braun, Hannover Medical School
- Investigators
- Uwe Tegtbur, Prof. Dr. med., Principal investigator, Hannover Medical School, Hannover Lower Saxony, Germany, 30625Anette Melk, Prof. Dr. med., Principal investigator, Medical School Hannover Lower Saxony, Germany, 30625
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942431
- Sponsor's protocol ID
- 7290
- Acronym
- RAS2
- Status last verified
- Oct 2024
- First submitted
- 8 Apr 2021
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REBIRTH Active School 2.0. Impact of a School-based Physical Activity Program on the Long-term Improvement of Student Health.
- ClinicalTrials.gov ID
- NCT04942431
- Acronym / sponsor ID
- RAS2 / 7290
- Conditions
- Primary School Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,245 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventiongroup | Experimental | Behavioral: Rebirth active SCHOOL 2.0 movement program60 min per day school based Physical activity program (for one year) |
| Waitinggroup | No intervention | –Intervention starts after one year. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- First and second grade pupils at primary schools (District Hannover/Wolfsburg/Helmstedt/Gifhorn/Hildesheim; Lower-Saxony, Germany),
Key exclusion criteria (1 listed)
- none, if no medical contraindications against intensive physical activity/tests excist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebirth active SCHOOL 2.0 movement program60 Minutes of physical activity per day integrated in every school-day. | Behavioural | Interventiongroup |
Primary outcome
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):
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.
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)
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)
48 secondary outcomes
Peripheral blood pressure
Time frame: At baseline, after 1 and 2 years.
Central blood pressure
Time frame: At baseline, after 1 and 2 years.
Arterial pulse wave
Time frame: At baseline, after 1 and 2 years.
Quality of life via KidKindl
Time frame: At baseline, after 1 and 2 years.
Physical activity questionnaire
Time frame: At baseline, after 1 and 2 years.
BMI (kg/m^2)
Time frame: At baseline, after 1 and 2 years.
Body Fat Mass (kg), (%)
Time frame: At baseline, after 1 and 2 years.
Skeletal Muscle Mass (kg)
Time frame: At baseline, after 1 and 2 years.
Fat Free Mass (kg)
Time frame: At baseline, after 1 and 2 years.
Body height (cm)
Time frame: At baseline, after 1 and 2 years.
Waist - Hip circumferences (cm)
Time frame: At baseline, after 1 and 2 years.
Concentration ability
Time frame: At baseline, after 1 and 2 years.
Pediatric Quality of Life
Time frame: At baseline, after 1 and 2 years.
Cognitive function
Time frame: At baseline, after 1 and 2 years.
Dental health Status
Time frame: At baseline, after 1 and 2 years.
Program adherence
Time frame: Whole intervention period (24 month)
Phosphat (mmol/l)
Time frame: At baseline, after 1 and 2 years.
CysC; Cystatin C (mg/l)
Time frame: At baseline, after 1 and 2 years.
Urea (mg/dl)
Time frame: At baseline, after 1 and 2 years.
Kreatinin (mg/dl)
Time frame: At baseline, after 1 and 2 years.
Uric acid (mg/dl)
Time frame: At baseline, after 1 and 2 years.
GPT; Glutamate pyruvate transaminase (U/l)
Time frame: At baseline, after 1 and 2 years.
Bilirubin (mg/dl)
Time frame: At baseline, after 1 and 2 years.
Triglyceride (mg/dl)
Time frame: At baseline, after 1 and 2 years.
Albumin (g/l)
Time frame: At baseline, after 1 and 2 years.
CRPhs; High-sensitivity C-reactive protein (mg/l)
Time frame: At baseline, after 1 and 2 years.
HbA1c (%)
Time frame: At baseline, after 1 and 2 years.
Cortisol (µg/l),
Time frame: At baseline, after 1 and 2 years.
Insulin (U/l )
Time frame: At baseline, after 1 and 2 years.
Leukozyten (Tsd/µl)
Time frame: At baseline, after 1 and 2 years.
Erythrozyten (Mio/µl)
Time frame: At baseline, after 1 and 2 years.
Hb; Hemoglobin (g/dl),
Time frame: At baseline, after 1 and 2 years.
Hkt;hematocrit (%)
Time frame: At baseline, after 1 and 2 years.
MCHC ean corpuscular hemoglobin concentration (g/dl)
Time frame: At baseline, after 1 and 2 years.
Thrombozyten (Tsd/µl)
Time frame: At baseline, after 1 and 2 years.
Natrium (mmol/l)
Time frame: At baseline, after 1 and 2 years.
Kalium (mmol/l)
Time frame: At baseline, after 1 and 2 years.
Calcium (mmol/l)
Time frame: At baseline, after 1 and 2 years.
Cholesterin (mg/dl)
Time frame: At baseline, after 1 and 2 years.
HDL; High Density Lipoprotein (mg/dl)
Time frame: At baseline, after 1 and 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
Related trials for Primary School Children
Not yet recruiting
Gamified Versus Regular Exercise Snacks on Stationary Bikes, as One 10-Minute or Two 5-Minute Sessions a Day, for Children in an Inclusive Primary School
Exercise, Sedentary Behavior
Enrolling by invitation
Physical and Psychosocial Outcomes of 16-Week Classroom-Based Morning Exercise Program
Healthy Children
Recruiting
Testing Interventions to Mitigate the Health Impact of Heatwaves on Primary School Children in Climate-vulnerable Districts of Bangladesh.
Heat Cramps, Heat Rash
Active, not recruiting
App-based Motor Skills Intervention in Primary School and Home Settings
Healthy, Motor Activity
Not yet recruiting
AI-Assisted Versus Independent Heart Sound Screening for Congenital Heart Disease in Children
Congenital Heart Disease (CHD), Artifical Intelligence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Tegtbur, Prof. Dr. med. principal investigator
Hannover Medical School, Hannover Lower Saxony, Germany, 30625
Anette Melk, Prof. Dr. med. principal investigator
Medical School Hannover Lower Saxony, Germany, 30625
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rebirth active SCHOOL 2.0 movement program in people with Primary School Children, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endurance capacity via Six-Minutes Running test (time frame: At baseline, after 1 and 2 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.