Evaluation of effect of coenzyme q10 and aerobic exercise on inflammatory, oxidative state and cardiorespiratory fitness in patients with traumatic brain injury
The purpose of the present study is to investigate the effect of coenzyme q10 and aerobic exercise on inflammatory, oxidative state and cardiorespiratory fitness in patients with traumatic brain injury. In this clinical trial study that double-blinded for patients and researchers, patients with Simple randomization separated into two group of 30: the control group with no intervention and intervention group will get coenzyme q10, and do aerobic exercise. They will be evaluated cognitively and functionally using FFS and FIM questionnaires. After an initial assessment, interventions begin. The intervention group will receive 2.5 mg/kg/day Coenzyme Q10 for 3 months and also will do exercise 60-90 minutes, three times a week for 12 weeks. Burce protocol for the cardiopulmonary function was used and respiratory gas analyzer used for respiratory gases. Before and after the study Blood samples will be taken to measure inflammatory factors: IL-6 and hs-
CRP. Also, total antioxidant capacity, Malondialdehyde and Glutathione peroxidase will be measured. inclusion: History of Traumatic Brain Injury 6 months ago, 18-65 years old and ability to cycling to do exercise. exclusion: Severe behavioral, physical and cognitive status preventing completing the study, Failure to cooperate until the end of the study, smoking and Drug addiction.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071626805N2
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Samira Mis Ghavam
Name of organization / entity
Ilam University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 84 3222 7150
Email address
ghavam-sm@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ilam University of Medical Sciences
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of coenzyme q10 and aerobic exercise on inflammatory, oxidative state and cardiorespiratory fitness in patients with traumatic brain injury
Public title
Evaluation of effect of coenzyme q10 and aerobic exercise on inflammatory, oxidative state and cardiorespiratory fitness in patients with traumatic brain injury
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: History of Traumatic Brain Injury 6 months ago; 18-65 years old; Stable clinical situation; Having a medical certificate proving participants’ ability to do exercise test; Commitment to complete the study; Ability to understand speech commands to complete study and ability to cycling to do exercise.
Exclusion criteria: Severe behavioral, physical and cognitive status preventing completing the study; chronic and systemic disease(cardiovascular, pulmonary...); Failure to cooperate until the end of the study; smoking and Drug addiction.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ilam University of Medical Sciences
Street address
Ilam University of Medical Sciences, Banganjab, Pajuhesh Blvd., Ilam, Iran
City
Ilam
Postal code
6939177143
Approval date
2010-11-05, 1389/08/14
Ethics committee reference number
Ir.medilam.rec.1396.77
Health conditions studied
1
Description of health condition studied
traumatic brain injury
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
IL-6
Timepoint
before intervention and 6th week and 12th week after begining of intervention
Method of measurement
The IL-6 will be measured by ELISA method and by the bender medsystem kit.
2
Description
Cardiac function
Timepoint
before intervention and 6th week and 12th week after begining of intervention
Method of measurement
Cardiac function will be tested with Bruce protocol.
3
Description
respiratory gasses
Timepoint
before intervention and 6th week and 12th week after begining of intervention
Method of measurement
respiratory gases automaticly will be analyzed using Ultima CardiO2.
4
Description
hs-CRP
Timepoint
before intervention and 6th week and 12th week after begining of intervention
Method of measurement
hs-CRP will be measured by ELISA method and by the bender medsystem kit.
5
Description
malondialdehyde
Timepoint
before intervention and 6th week and 12th week after begining of intervention
Method of measurement
Levels of malondialdehyde will be measured by the Randox kit.
6
Description
total antioxidant capacity
Timepoint
before intervention and 6th week and 12th week after begining of intervention
Method of measurement
total antioxidant capacity will be measured by the Randox kit.
7
Description
glutathione peroxidase
Timepoint
before intervention and 6th week and 12th week after begining of intervention
Method of measurement
glutathione peroxidase will be measured by the Randox kit.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: with no intervention.
Category
N/A
2
Description
Intervention group: the intervention group will receive 2.5 mg/kg/day Coenzyme Q10 for 3 months and they will do exercise 60-90 minutes, three times a week for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Hafezi Pathology Clinic
Full name of responsible person
Street address
next to the Red Crescent, 22-Bahman Sq., Ilam, Iran
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Ilam University of Medical Sciences
Full name of responsible person
Dr. Behzad Badakhsh
Street address
Vice chancellor for research and technology, Ilam University of Medical Sciences, Banganjab, Pajuhesh Blvd., Ilam, Iran
City
Ilam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ilam University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Asghar Rahmani
Position
GP, Member of Student Research Committee of Ilam University of Medical Sciences
Other areas of specialty/work
Street address
Research Committee of Ilam University of Medical Sciences, Medical School, Ilam University of Medical Sciences, Banganjab, Pajuhesh Blvd., Ilam, Iran
City
Ilam
Postal code
6939177143
Phone
+98 84 3222 7126
Fax
Email
Asrahmani1991@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Asghar Rahmani
Position
GP
Other areas of specialty/work
Street address
Research Committee of Ilam University of Medical Sciences, Medical School, Ilam University of Medical Sciences, Banganjab, Pajuhesh Blvd., Ilam, Iran
City
Ilam
Postal code
6939177143
Phone
+98 84 3222 7126
Fax
Email
Asrahmani1991@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Samira Mis Gavam
Position
Faculty member, Cardiologist
Other areas of specialty/work
Street address
Vice chancellor for research and technology, Ilam University of Medical Sciences, Banganjab, Pajuhesh Blvd., Ilam, Iran
City
Ilam
Postal code
6939177143
Phone
+98 84 3222 7150
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)