Assessing Cognitive Performance Among Adults With Attention Disorders Working on Treadmill

NCT ID: NCT05243186

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-10-31

Brief Summary

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Randomized clinical trial in which individuals who have been diagnosed with ADHD and are regularly treated with Methylphenidate will be test for cognitive performance and will be randomly examined in the following four conditions:

* While taking Methylphenidate and sitting at a desk
* While taking Methylphenidate and walking on a treadmill workstation
* Without taking Methylphenidate while sitting at a desk
* Without taking Methylphenidate while walking on a treadmill workstation The investigators will compare the cognitive achievements outcomes and evaluate the efficiency of studying in each of these four conditions.

Detailed Description

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The rationale of this clinical trial is to identify the intervention that best contributes to better cognition results of adults with ADHD's: physical activity, drug or a combination of the two? The study will enable to determine which factor will improve cognitive results. The findings of this trial will help determine the best treatment method that can be offer to adults with ADHD.

Conditions

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Attention Deficit Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

All participants will participate in four different sessions of the study that will be randomly crossed over.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

There are no masking in the study. All parties have all the information regard the conditions of the study.

Study Groups

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MPH walking

The participants will be instructed to work while taking Methylphenidate and walking on a treadmill workstation

Group Type EXPERIMENTAL

Treadmill workstation

Intervention Type DEVICE

walking on a treadmill workstation next to desk with computer and screen

Methylphenidate

Intervention Type DRUG

Using prescription drug

MPH sitting

The participants will be instructed to work while taking Methylphenidate and sitting at a desk

Group Type PLACEBO_COMPARATOR

Methylphenidate

Intervention Type DRUG

Using prescription drug

No MPH walking

The participants will be instructed to work without taking Methylphenidate while walking on a treadmill workstation

Group Type PLACEBO_COMPARATOR

Treadmill workstation

Intervention Type DEVICE

walking on a treadmill workstation next to desk with computer and screen

No MPH sitting

The participants will be instructed to work without taking Methylphenidate while sitting at a desk

Group Type PLACEBO_COMPARATOR

Treadmill workstation

Intervention Type DEVICE

walking on a treadmill workstation next to desk with computer and screen

Methylphenidate

Intervention Type DRUG

Using prescription drug

Interventions

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Treadmill workstation

walking on a treadmill workstation next to desk with computer and screen

Intervention Type DEVICE

Methylphenidate

Using prescription drug

Intervention Type DRUG

Other Intervention Names

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Walking on a treadmill workstation Ritalin

Eligibility Criteria

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Inclusion Criteria

\* Insured by Maccabi Health Services

* Diagnosed with ADHD by Neurologist/Psychiatrist/Developmental Doctor
* Take Methylphenidate as part of the treatment for ADHD AND have agreed to not take the drug if asked to
* Understand the language and simple instruction
* Willing to participate in the study and sign the agreement form

Exclusion Criteria

* Suffer from heart disease or chronic respiratory illness
* Women who are pregnant
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maccabi Healthcare Services, Israel

OTHER

Sponsor Role collaborator

Ariel University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Liat Korn, PhD

Role: PRINCIPAL_INVESTIGATOR

Ariel University

Locations

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Ariel University

Ariel, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Liat Korn, PhD

Role: CONTACT

972 50 9099201

Gideon Koren, Prof.

Role: CONTACT

972 58 7194777

Facility Contacts

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Liat Korn, PhD

Role: primary

972 50 9099201

Gideon Koren, MD

Role: backup

972 58 7194777

References

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Korn L, Hassan K, Fainshtein N, Yusov N, Davidovitch N. Non-Medical Use of Prescription Stimulants for Treatment of Attention Disorders by University Students: Characteristics and Associations. Med Sci Monit. 2019 May 21;25:3778-3787. doi: 10.12659/MSM.913973.

Reference Type BACKGROUND
PMID: 31111829 (View on PubMed)

Other Identifiers

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ArielUni

Identifier Type: -

Identifier Source: org_study_id

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