Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
ADHD
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: The study will be divided into two sub studies (100 participants each), in which 50 ADHD and 50 non-ADHD participants will be included. In the first session, all participants will undergo motor tests, in the same conditions. In the second session, half of ADHD participants (25) will be asked to take their regular MPH treatment, before the session. All other participants (25 ADHD and 50 non-ADHD) will perform the motor tests without treatment, and serve as control groups.Masking: None (Open Label)Primary Purpose: Other

Participation Requirements

Age
Between 18 years and 45 years
Gender
Both males and females

Description

Aim of study To evaluate the effects of MPH on young adults diagnosed with ADHD on different exercise performance tests. Hypothesis: Methylphenidate (MPH) will have positive effects on motor tests requiring concentration. Methods Participants 200 healthy physical education students from the Academic...

Aim of study To evaluate the effects of MPH on young adults diagnosed with ADHD on different exercise performance tests. Hypothesis: Methylphenidate (MPH) will have positive effects on motor tests requiring concentration. Methods Participants 200 healthy physical education students from the Academic college at Wingate, males and females, will be recruited to the study. 100 participants diagnosed with ADHD will serve as the treatment group and 100 non-ADHD diagnosed will serve as a control group. Procedure Recruitment procedure will consist of emails to all students in college. Volunteers answering the mail will be regarded as giving consent to be addressed by the research assistant by a phone call. A research assistant will call volunteers and will briefly explain the study procedures and invite them for two sessions. ADHD volunteers will kindly be asked to arrive to the first session before taking their medication. They will be instructed to take by themselves their medication, if needed, after they finished the session. The study will be divided into two sub studies (100 participants each), in which, two motor tests will be evaluated (two agility tests and two motor accuracy tests). The division was meant to attenuate fatigue resulted from multiple motor tests at the same session. The students will be recruited for the two sub -studies but may choose to participate in only one part. In each sub-study, the participant will attend two sessions, about sixty minutes each, at least one week apart between them. In the first session, participants will sign an informed consent form approved by the institutional review board (Helsinki). Next, all participants will fill a general background questionnaire and an ADHD self-report scale questionnaire. Then, participants will perform the motor tests. After the first session, half of the participants with ADHD will undergo another session of the same motor tests with their usual treatment (treatment group) or without their treatment (ADHD control group). We point out that the patient takes his own treatment himself when assigned to the ADHD treatment group. The assignment to the treatment group or to the control group will be randomly decided, and will consist of 25 participants in each group. The non-ADHD control group (50 participants) will perform the second session without medications - to assess a learning effect. The participants will be able to choose to participate in the next sub-studies or not. Treatment The treatment will include taking the patient's own medication by the patient himself in the treatment session 60-180 minutes before the beginning of the tests, according to their prescription given by their own physician. Participants must have consumed this medication at least 3 months before the first session as their regular treatment for ADHD. Note, we are not planning on giving the medication to the participant, rather he/she will consume their own prescribed MPH by themselves. Control treatment for ADHD participants will consist of not taking their medication before the motor test. Since there may be participant who needs to take the medication every day, they will be instructed to consume their medication at the end of the session. In this case, session meeting will be performed at morning time. Motor tests Sub-study 1 Agility tests Two agility tests will be performed. The best time of each test will be recorded. Calculation of the ratio of zigzag test without the ball and with the ball will be conducted on a sports hall. These two agility tests were evaluated and validated elsewhere. Zigzag test- Running agility test. Participant is required to run a course in the shortest possible time. A zigzag course consists of a rectangle 3 X 5 meters set out at 100º angles by four cones placed on the corners, with one more cone placed in the center (Fig 1). Overall there are 6 segments numbered from 1-6 according to their order in the test. This test measures rapid acceleration, deceleration and balance control. Zigzag with a ball- The same as the former test (fig 1), but with a ball. Participants will be instructed to run as fast as possible with the ball. This test measures rapid acceleration, deceleration and balance control as well as controlling the ball. Sub-study 2 Accuracy motor tests The stationary free throw shooting test (S1P)- Each participant will perform three series of ten free-throw shots (two throws in five different positions) with a 3-minute rest period between the series. Two participants will be positioned below the hoop and they will pass the ball to the testee. After the participant completes ten shots, another participant will come to the free throw line and will perform the same task. The average scores of the all three trials will be used for analysis. The dynamic 60-second free throw shooting test (S1P60)- For easier organization of the testing we will use volleyball court lines as illustrated in Figure 1. Each participant will perform five series of two free throws with sprinting between the series. Each series will be completed in 12 seconds. Each participant will start the test with an 18-meter sprint (volleyball court sideline), then will turn around a cone and run to the free throw line. After performing two free throws the participant will run to another cone where he will wait for a sound signal to start the next series. One tester will use a stopwatch to measure 12 seconds, and to give a signal to the participant. Another tester will count the number of free throws made. Two other participants will pass the balls to the testee. The participants will perform the three S1P60 tests with a five-minute recovery time between each. The average score of all three trials will be used for analysis.

Tracking Information

NCT #
NCT04283604
Collaborators
  • Tel Aviv University
  • Wingate Institute
Investigators
Not Provided