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). 1. st encounter: the subjects will receive an explanation of the study and sign an informed consent form, complete a medical questionnaire and undergo physical examination by a physician, including ECG. 2. nd-9th encounter: the subjects will be requested to undergo 10 tests on 8 examination days, which will include the: maximal oxygen consumption test, wingate test, heat tolerance test and step test. Each subject will perform each test twice: once while taking MPH and once with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
20
oral capsules (per os) each containing 10mg Methylphenidate.
capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.
Sheba medical center
Tel Litwinsky, Ramat- Gan, Israel
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.
Time frame: 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 ).
Time frame: 2 experimental days for each participant
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).
Time frame: 2 experimental days for each participant
skin temperature
The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
Time frame: 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).
Time frame: 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.
Time frame: 8 experimental days for each participant
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