The Effect of Combined Exercise Training with Resistance Dominant and Coenzyme Q10 Supplementation on Brain-Derived Neurotrophic Factor (BDNF) and Nerve Growth Factor (NGF) in patient with multiple sclerosis
The purpose of this study was to investigate the effect of eight weeks of combined resistance training with supplementation of coenzyme Q10 on serum levels of Brain-Derived Neurotrophic Factor (BDNF) and Nerve Growth Factor (NGF) in patients with multiple sclerosis.
Design
Clinical trial with control group, with parallel groups, no blinded, randomized
Settings and conduct
MS Case Study
The place to do that community is Mashhad
Twenty eight patients were selected by available sampling method and randomly divided into three experimental groups (complementary exercise training Q10, placebo, placebo, Q10 supplementation) and a control (placebo) group.
Participants/Inclusion and exclusion criteria
2 years old with MS
Not doing regular exercise
Non-smoking
Intervention groups
Combined exercise + Q10 Supplement group
Combined exercise + placebo group
Q10 Supplemental group
Main outcome variables
Brain-Derived Neurotrophic Factor (BDNF) and Nerve Growth Factor (NGF)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170911036117N2
Registration date:2019-08-11, 1398/05/20
Registration timing:registered_while_recruiting
Last update:2019-08-11, 1398/05/20
Update count:0
Registration date
2019-08-11, 1398/05/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2765
Email address
elia_3812@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-11, 1398/05/20
Expected recruitment end date
2019-08-16, 1398/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Combined Exercise Training with Resistance Dominant and Coenzyme Q10 Supplementation on Brain-Derived Neurotrophic Factor (BDNF) and Nerve Growth Factor (NGF) in patient with multiple sclerosis
Public title
The effect of training on MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
2 years old with MS
Not doing regular exercise
Non-smoking
Exclusion criteria:
Use of the cortoone
Expanded Disability Status Scale (EDSS) more than 5
Expanded Disability Status Scale (EDSS) less than 3
Age
From 25 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual random
Description: Writing the names of subjects and randomly taking names and placing them in a specified order in four research groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Sabzevar University of Medical Sciences
Street address
Asad Abadi Street - Central Office of Medical Sciences
City
sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Approval date
2016-05-30, 1395/03/10
Ethics committee reference number
IR.MEDSAB.REC.1395.29
Health conditions studied
1
Description of health condition studied
multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Brain-derived growth factor and Nervous Growth Factor
Timepoint
24 hours before the start and 48 hours after the end of the intervention
Method of measurement
ELISA method and using special kit
Secondary outcomes
1
Description
Brain-derived growth factor and Nervous Growth Factor
Timepoint
24 hours before the start and 48 hours after the end of the intervention
Method of measurement
ELISA method and using special kit
Intervention groups
1
Description
Intervention group:Combined exercise training + supplementation of coenzyme Q10. Intervention of this group will be combined exercise training consist of two sessions of 50% resistance training with a maximum of one repetition and one session of aerobic exercise with 50% maximal oxygen consumption at the start of the study with daily intake of 200 mg Coenzyme Q10 manufactured by Canadian Notary Century for eight weeks.
Category
Lifestyle
2
Description
Intervention group: Combined exercise training + placebo. Intervention of this group will be combined exercise training consist of two sessions of 50% resistance training with a maximum of one repetition and one session of aerobic exercise with 50% maximal oxygen consumption at the start of the study with daily intake of placebo (starch powder) for eight weeks.
Category
Lifestyle
3
Description
Intervention group: supplementation of coenzyme Q10. Intervention of this group will be intake daily of 200 mg Coenzyme Q10 manufactured by Canadian Notary Century for eight weeks.
Category
Treatment - Drugs
4
Description
Control group: placebo. Intervention of this group will be daily intake of placebo (starch powder) for eight weeks.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Khorasan Razavi Society
Full name of responsible person
Karim Nikkhah
Street address
50th Street, Ghaem 12, Ahmadabad Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Fax
Email
hakim@hsu.ac.ir
Web page address
https://msmashhad.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Hakim Sabzevari
Full name of responsible person
Amir Hosein Haghighi
Street address
Hakim Sabzevari University, Towhid City, Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4441 0104
Email
hakim@hsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Hakim Sabzevari
Proportion provided by this source
5
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Zabol
Full name of responsible person
Javad Nakhzari Khodakheir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 25, Shahid Bagheri
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861935645
Phone
+98 54 3222 3736
Email
elia_3812@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Zabol
Full name of responsible person
Javad Nakhzari Khodakheir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 25, Shahid Bagheri
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861935645
Phone
+98 54 3222 3736
Email
elia_3812@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Zabol
Full name of responsible person
Javad Nakhzari Khodakheir
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 25, Shahid Bagheri
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861935645
Phone
+98 54 3222 3736
Email
elia_3812@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available