Attention Deficit Hyperactivity Disorder
Conditions
Keywords
Physical Training, ADHD-Attention deficit hyperactivity disorder, Omega 3
Brief summary
The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life.
Detailed description
The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause disabilities through whole life. The treatment of this disease is expensive and difficult. Moreover, physical exercise and omegas consumption may improve the cognitive functions and behavior, so it could be an interesting strategy to improve this disorder. The aim of the present study is to verify the effects of multiple components physical training and the consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be selected. The volunteers will be randomly divided into four groups: Physical Training Group (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The protocol of the experiment will last three months in which the OPTG will make physical training and receive fish oil capsules, and the PTG will make only the physical training and receive a placebo of fish oil. The others groups will be oriented not to make any type of physical training, but the OG will receive fish oil capsule, and the CG will receive a placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will be made at the beginning and at the end of the protocol.
Interventions
DIETARY_SUPPLEMENTOmega 3
Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
OTHERPhysical Training
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
7 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Children with ADHD: male, between seven and fourteen years old, sedentary, studing in a regular school.
Exclusion criteria
* Taking psychoactive medications, taking omega supplement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conners Scale | 3 months | Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Omega-3 Only Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day. | 14 |
| Sedentary (Control) The sedentary group will be oriented not to make any type of physical training for three months.
Omega 3: Capsules of omega 3, 1000mg / capsules. Administered 3 times a day. | 14 |
| Placebo + Phsycal Training The omega 3 group will receive 2g per day of mineral oil during 90 days treatment
Physical Training | 12 |
| Omega 3 + Phsycal Training The omega 3 group will receive 2g per day of fish oil during 90 days treatment
Physical Training | 13 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Omega-3 Only | Sedentary (Control) | Placebo + Phsycal Training | Omega 3 + Phsycal Training | Total |
|---|---|---|---|---|---|
| Age, Continuous | 10.27 years STANDARD_DEVIATION 2.2 | 10.85 years STANDARD_DEVIATION 2.03 | 10.36 years STANDARD_DEVIATION 2.71 | 10.55 years STANDARD_DEVIATION 2.94 | 10.5075 years STANDARD_DEVIATION 2.47 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 14 Participants | 12 Participants | 13 Participants | 53 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 00 Participants | 00 Participants | 00 Participants | 00 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 00 Participants | 00 Participants | 00 Participants | 00 Participants | 0 Participants |
| Region of Enrollment Brazil | 14 participants | 14 participants | 12 participants | 13 participants | 53 participants |
| Sex: Female, Male Female | 00 Participants | 00 Participants | 00 Participants | 00 Participants | 0 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 12 Participants | 13 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 14 | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 | 0 / 12 | 0 / 13 |
Outcome results
Primary
Conners Scale
Scores on the Conners scale. Scores above 60 indicate ADHD. Minimum 0 and a maximum of 126.
Time frame: 3 months
Population: Conners scale and the child stress scale (ESI)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omega-3 Only | Conners Scale | 36.64 units on a scale | Standard Deviation 12.75 |
| Sedentary (Control) | Conners Scale | 42.31 units on a scale | Standard Deviation 12.1 |
| Placebo + Phsycal Training | Conners Scale | 40.08 units on a scale | Standard Deviation 14.47 |
| Omega 3 + Phsycal Training | Conners Scale | 36.82 units on a scale | Standard Deviation 7.91 |
p-value: 0.05Chi-squared, Corrected