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The purpose of this study is to explore the possible effects of MPH use on physiological functions among ADHD\ADD patients, by performing a set of physical trials to assess aerobic and anaerobic capacity, to characterize the tendency for muscle break down while performing monitored moderate physical effort and to assess the physiological strain while performing moderate exercise in heat load conditions by using the heat tolerance test.
20 male, non-combat soldiers with a pre-existing childhood diagnosis of ADHD\ADD, who are chronically treated with MPH will participate in the study. If necessary, civilian volunteers with a childhood diagnosis of ADHD\ADD may also be recruited to complete the study population (up to 50%, i.e. 10 participants).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Experimental | In experimental days taking MPH, subjects will take 20mg Ritalin® (Novartis AG) in two tablets of 10mg, by swallow 1 hour prior to performing the physical test. |
|
| Placebo | Placebo Comparator | In experimental days with placebo subjects will be asked to ingest 2 capsules identical to Ritalin® capsules, by swallow 1 hour prior to performing the physical test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate | Drug | oral capsules (per os) each containing 10mg Methylphenidate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| physiological strain (composite) | the physiological strain will be determined by monitoring body core temperature and heart rate of the subjects during a Heat Tolerant Test (HTT). the test is performed in a climatic chamber. during the test the subjects walks on a treadmill (5 km/h and 2% incline) for 2h. | 2 experimental days for each participant |
| aerobic capacity | the aerobic capacity of the subjects will be determined by performing a maximal oxygen consumption test (VO2max). VO2 will be monitored continuously with a metabolic system (ERGOTEST 680, ZAN, GERMANY ). | 2 experimental days for each participant |
| Measure | Description | Time Frame |
|---|---|---|
| Rectal temperature | rectal temperature will be recorded at a depth of 10 mm past the anal sphincter using YSI-401 thermal thermistor during each heat tolerance test (HTT). | 2 experimental days for each participant |
| skin temperature |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haggai Schermann, M.D | Contact | +972828771014 | Haggai.Schermann@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Haggai Schermann, M.D | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba medical center | Tel Litwinsky | Ramat- Gan | Israel |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| C041626 | 5,10-dihydro-5-methylphenazine |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Placebo | Drug | capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation. |
|
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
| 2 experimental days for each participant |
| heart rate | The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch). | 8 experimental days for each participant |
| lactic acid | lactic acid level is assessed from blood drop (finger sting), will be taken before and after every test. lactic acid is a marker for anaerobic effort evaluating. | 8 experimental days for each participant |
| D010880 |
| Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |