Clinical Trial: Methylphenidate (Ritalin®) Effect During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: The Effect of the Drug Methylphenidate on Physiological Stress and Function During Exposure to Exercise and Heat Stress in ADD/ADHD Treated Patients
Brief Summary: 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.
Detailed Summary:
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).
- 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.
- 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.
Sponsor: Sheba Medical Center
Current Primary Outcome:
- physiological strain (composite) [ Time Frame: 2 experimental days for each participant ]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.
- aerobic capacity [ Time Frame: 2 experimental days for each participant ]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 ).
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Rectal temperature [ Time Frame: 2 experimental days for each participant ]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).
- skin temperature [ Time Frame: 2 experimental days for each participant ]The skin temperature will be monitored by skin thermistors located at 3 sites (chest, arm and leg).
- heart rate [ Time Frame: 8 experimental days for each participant ]The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
- lactic acid [ Time Frame: 8 experimental days for each participant ]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.
Original Secondary Outcome: Same as current
Information By: Sheba Medical Center
Dates:
Date Received: March 6, 2016
Date Started: April 2016
Date Completion: September 2017
Last Updated: March 9, 2016
Last Verified: March 2016
