Influence of Aerobic Exercise on Inhibitory Control of Excutive Function in Spastic Hemiplegic C.P

NCT ID: NCT04154566

Last Updated: 2019-12-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-08-01

Brief Summary

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The study was conducted to assess the influence of aerobic exercise on inhibitory control of executive functions in spastic hemiplegic cerebral palsy.

Detailed Description

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Inhibitory control of executive functions (EF) is one of the main specific cognitive impairments that affect children with cerebral palsy, cognitive skills begin to develop in infancy and continuing through the pre-school years, childhood and into adolescence it changes across the lifespan of an individual and has great effect on their participation and quality of life. The aim of study was to assess the influence of aerobic exercise on inhibitory control of executive functions in spastic hemiplegic cerebral palsy. Sixty children with spastic hemiplegic cerebral palsy were enrolled in this study and were assessed for eligibility. Their aged ranged from seven and eleven years. They were assigned randomly into two equal groups. Group (A) the study group received aerobic exercise in addition to selected physical therapy program. And group (B) the control group received the same selected physical therapy program only. The treatment was conducted for one hour, three times / weak for three successful months. Eriksen flanker test and Stroop Color-Word test were used to assess inhibitory control of EF pre and post treatment.

Conditions

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Spastic Hemiplegic Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

They were assigned randomly into two equal groups. Group (A) the study group received aerobic exercise in addition to selected physical therapy program. And group (B) the control group received the same selected physical therapy program only. The treatment was conducted for one hour, three times / weak for three successful months.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinding process to participants and care providers was impossible due to the nature of intervention therapy. Data were analyzed by an impartial statistician (outcomes assessor), referring to each arm with an encoded name: Group A (control group) and Group B (study group).

Study Groups

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the study group

Group (A) the study group received aerobic exercise in addition to selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and gait training exercises in open environment.

Group Type EXPERIMENTAL

Aerobic Exercises

Intervention Type OTHER

Aerobic exercise refers to exercise that involves or improves oxygen consumption by the body. It is the type of activity that uses large muscle groups. Its performance is in a continuous and rhythmic way with a main goal to make the heart and lungs work harder than they do when the person at rest

the control group

group (B) the control group received the same selected physical therapy program which contain strengthening exercises for upper limb and lower limb muscles, stretching exercises for elbow extensors, hand supinator, wrist extensors, knee extensors and ankle dorsiflexors, balancing exercises, coordination exercises and gait training exercises in open environment only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aerobic Exercises

Aerobic exercise refers to exercise that involves or improves oxygen consumption by the body. It is the type of activity that uses large muscle groups. Its performance is in a continuous and rhythmic way with a main goal to make the heart and lungs work harder than they do when the person at rest

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Their aged ranged from seven and eleven years.
* they were from both sexes.
* they have left side hemiplegic cerebral palsy.
* they were able to walk independently.

Exclusion Criteria

* children with visual or auditory problems.
* children with history of drug intake that may affect the cognitive function.
* medically unstable children especially with cardiovascular disorders.
* uncooperative children.
Minimum Eligible Age

7 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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South Valley University

OTHER

Sponsor Role lead

Responsible Party

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Mohammed E. Ali, Ph. D Candidate.

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nehad A. Abo-zaid, PhD

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Faculty of Physical Therapy

Mohammed E. Ali, PhD student

Role: PRINCIPAL_INVESTIGATOR

South Valley University, Faculty of Physical Therapy

Locations

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South Valley University, Faculty of Physical Therapy

Qina, , Egypt

Site Status

Countries

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Egypt

References

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Sutoo D, Akiyama K. Regulation of brain function by exercise. Neurobiol Dis. 2003 Jun;13(1):1-14. doi: 10.1016/s0969-9961(03)00030-5.

Reference Type BACKGROUND
PMID: 12758062 (View on PubMed)

Chang YK, Labban JD, Gapin JI, Etnier JL. The effects of acute exercise on cognitive performance: a meta-analysis. Brain Res. 2012 May 9;1453:87-101. doi: 10.1016/j.brainres.2012.02.068. Epub 2012 Mar 4.

Reference Type BACKGROUND
PMID: 22480735 (View on PubMed)

Wecker NS, Kramer JH, Wisniewski A, Delis DC, Kaplan E. Age effects on executive ability. Neuropsychology. 2000 Jul;14(3):409-14. doi: 10.1037//0894-4105.14.3.409.

Reference Type BACKGROUND
PMID: 10928744 (View on PubMed)

Kluding PM, Tseng BY, Billinger SA. Exercise and executive function in individuals with chronic stroke: a pilot study. J Neurol Phys Ther. 2011 Mar;35(1):11-7. doi: 10.1097/NPT.0b013e318208ee6c.

Reference Type BACKGROUND
PMID: 21475079 (View on PubMed)

Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.

Reference Type RESULT
PMID: 17370477 (View on PubMed)

Garne E, Dolk H, Krageloh-Mann I, Holst Ravn S, Cans C; SCPE Collaborative Group. Cerebral palsy and congenital malformations. Eur J Paediatr Neurol. 2008 Mar;12(2):82-8. doi: 10.1016/j.ejpn.2007.07.001. Epub 2007 Sep 19.

Reference Type RESULT
PMID: 17881257 (View on PubMed)

Holmefur M, Kits A, Bergstrom J, Krumlinde-Sundholm L, Flodmark O, Forssberg H, Eliasson AC. Neuroradiology can predict the development of hand function in children with unilateral cerebral palsy. Neurorehabil Neural Repair. 2013 Jan;27(1):72-8. doi: 10.1177/1545968312446950. Epub 2012 Jun 6.

Reference Type RESULT
PMID: 22677505 (View on PubMed)

Arner M, Eliasson AC, Nicklasson S, Sommerstein K, Hagglund G. Hand function in cerebral palsy. Report of 367 children in a population-based longitudinal health care program. J Hand Surg Am. 2008 Oct;33(8):1337-47. doi: 10.1016/j.jhsa.2008.02.032.

Reference Type RESULT
PMID: 18929198 (View on PubMed)

Hielkema T, Hadders-Algra M. Motor and cognitive outcome after specific early lesions of the brain - a systematic review. Dev Med Child Neurol. 2016 Mar;58 Suppl 4:46-52. doi: 10.1111/dmcn.13047.

Reference Type RESULT
PMID: 27027607 (View on PubMed)

McClelland MM, Cameron CE, Duncan R, Bowles RP, Acock AC, Miao A, Pratt ME. Predictors of early growth in academic achievement: the head-toes-knees-shoulders task. Front Psychol. 2014 Jun 17;5:599. doi: 10.3389/fpsyg.2014.00599. eCollection 2014.

Reference Type RESULT
PMID: 25071619 (View on PubMed)

Wolf SA, Kronenberg G, Lehmann K, Blankenship A, Overall R, Staufenbiel M, Kempermann G. Cognitive and physical activity differently modulate disease progression in the amyloid precursor protein (APP)-23 model of Alzheimer's disease. Biol Psychiatry. 2006 Dec 15;60(12):1314-23. doi: 10.1016/j.biopsych.2006.04.004. Epub 2006 Jun 27.

Reference Type RESULT
PMID: 16806094 (View on PubMed)

Pereira AC, Huddleston DE, Brickman AM, Sosunov AA, Hen R, McKhann GM, Sloan R, Gage FH, Brown TR, Small SA. An in vivo correlate of exercise-induced neurogenesis in the adult dentate gyrus. Proc Natl Acad Sci U S A. 2007 Mar 27;104(13):5638-43. doi: 10.1073/pnas.0611721104. Epub 2007 Mar 20.

Reference Type RESULT
PMID: 17374720 (View on PubMed)

McMorris T, Hale BJ. Differential effects of differing intensities of acute exercise on speed and accuracy of cognition: a meta-analytical investigation. Brain Cogn. 2012 Dec;80(3):338-51. doi: 10.1016/j.bandc.2012.09.001. Epub 2012 Oct 11.

Reference Type RESULT
PMID: 23064033 (View on PubMed)

Gellish RL, Goslin BR, Olson RE, McDonald A, Russi GD, Moudgil VK. Longitudinal modeling of the relationship between age and maximal heart rate. Med Sci Sports Exerc. 2007 May;39(5):822-9. doi: 10.1097/mss.0b013e31803349c6.

Reference Type RESULT
PMID: 17468581 (View on PubMed)

Boyd RN, Davies PS, Ziviani J, Trost S, Barber L, Ware R, Rose S, Whittingham K, Sakzewski L, Bell K, Carty C, Obst S, Benfer K, Reedman S, Edwards P, Kentish M, Copeland L, Weir K, Davenport C, Brooks D, Coulthard A, Pelekanos R, Guzzetta A, Fiori S, Wynter M, Finn C, Burgess A, Morris K, Walsh J, Lloyd O, Whitty JA, Scuffham PA. PREDICT-CP: study protocol of implementation of comprehensive surveillance to predict outcomes for school-aged children with cerebral palsy. BMJ Open. 2017 Jul 12;7(7):e014950. doi: 10.1136/bmjopen-2016-014950.

Reference Type RESULT
PMID: 28706091 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P. T. REC/012/002278

Identifier Type: -

Identifier Source: org_study_id

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