The effect of an 8-week aerobic training at home and vitamin D supplementation on serum values of Brain-derived neurotrophic factor (BDNF), Nerve growth factor (NGF), fatigue level and quality of life in patients with Multiple Sclerosis During Covid-19 quarantine
The aim of this study was to evaluate the effect of 8-weeks of aerobic training at home and vitamin D supplementation on serum levels of BDNF, NGF, fatigue and quality of life in patients with multiple sclerosis during Covid-19 quarantine.
Design
For this purpose, 36 women with multiple sclerosis will be randomly divided into 4 groups: aerobic training + vitamin supplementation, aerobic training, vitamin D supplementation and control, as well as vitamin D intake (about 50,000 IU= 1/25 mg per week for eight weeks); Or it will be a placebo. The aerobic training protocol includes 25 to 40 minutes of aerobic exercise with an intensity of 50 to 70% of the maximum heart rate, 3 times a week for eight weeks and online.
Settings and conduct
This study was a clinical trial on the effect of 8-weeks of aerobic training at home and vitamin D supplementation on serum levels of BDNF, NGF, fatigue and quality of life in patients with multiple sclerosis during coronary quarantine under the supervision of Razi University of Kermanshah. Pre-test and post-test will be performed.
Participants/Inclusion and exclusion criteria
At least 2 years of disease history
Expanded Disability Status Scale (3-5)
Lack of regular exercise
No smoking
Do not take immunosuppressive drugs
Heart disease
High blood pressure
Orthopedic disorders
Use of other drugs in addition to MS drugs
Intervention groups
Aerobic training (placebo); Vitamin D supplementation (no AT); Aerobic training with vitamin D supplements (AT+Vit D); and Control (placebo+no AT)
Main outcome variables
Brain-derived neurotrophic factor (BDNF)- Nerve growth factor (NGF)- Fatigue- quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201129049525N1
Registration date:2021-05-16, 1400/02/26
Registration timing:prospective
Last update:2021-05-16, 1400/02/26
Update count:0
Registration date
2021-05-16, 1400/02/26
Registrant information
Name
Elahe Bahmani Meianrodi
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 7186
Email address
elbahmani74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-20, 1400/02/30
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of an 8-week aerobic training at home and vitamin D supplementation on serum values of Brain-derived neurotrophic factor (BDNF), Nerve growth factor (NGF), fatigue level and quality of life in patients with Multiple Sclerosis During Covid-19 quarantine
Public title
The effect of aerobic training at home and vitamin D supplementation in MS During Covid-19 quarantine
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Multiple sclerosis (MS) with at least 2 years of history
Lack of regular exercise
Do not take immunosuppressive drug
No smoking
Expanded Disability Status Scale (3-5)
Exclusion criteria:
Heart disease
High blood pressure
Orthopedic disorders
Use of other drugs in addition to MS drugs
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
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 Razi University of Kermanshah
Street address
No. 8, University Blvd, Kermanshah Province, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
۶۷۱۴۴۱۴۹۷۱
Approval date
2021-04-03, 1400/01/14
Ethics committee reference number
IR.RAZI.REC.1400.002
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
Vitamin D
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
2
Description
Brain-derived neurotrophic factor
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
3
Description
Nerve growth factor
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
4
Description
IL-10
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
5
Description
TNF-Alpha
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By Blood sampling
6
Description
Fatigue
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By questionnaire
7
Description
Quality of life
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Aerobic training + vitamin D supplementation group: The aerobic training + vitamin D supplementation Intervention will be consists of 25-40 minutes of aerobic exercise at 50% - 70% of HRmax, 3 times a week for eight weeks online and vitamin D supplementation will be receiving vitamin D (∼50000 IU • week for eight weeks) receiving vitamin D (about 50,000 IU per week for 8-weeks).
Category
Lifestyle
2
Description
Intervention group 2: aerobic training group: Aerobic training consists of 25 to 40 minutes of aerobic exercise with an intensity of 50 to 70% of maximum heart rate, 3 times a week for eight weeks online.
Category
Lifestyle
3
Description
Intervention group 3: Vitamin D supplementation group: Vitamin D supplementation includes receiving vitamin D (∼50000 IU • week for eight weeks).
Category
Lifestyle
4
Description
Control group: Control group: receiving placebo and no aerobic training for eight weeks.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah MS Clinic
Full name of responsible person
Elahe Bahmani mianroudi
Street address
No. 9, Razi University Blvd؛ Taq Bostan, Faculty of Physical Education and Sports Sciences.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3428 3270
Fax
+98 83 3428 3270
Email
elbahmani74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Razi University of Kermanshah
Full name of responsible person
Dr. Farzad Veysi
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3278
Email
R.Hoseini@razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Razi University of Kermanshah
Proportion provided by this source
100
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
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3427 7605
Fax
+98 83 3427 7605
Email
R.hoseini@razi.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
0098 34279265
Fax
+98 83 3427 7605
Email
R.hoseini@razi.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Elahe Bahmani mianroudi
Position
Master
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714767874
Phone
0098 4224220
Email
elbahmani74@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be record in the SPSS software and will be available
When the data will become available and for how long
Availability will start nine months after publishing all papers
To whom data/document is available
Only available for researchers in academic and scientific institutions
Under which criteria data/document could be used
All data can be used as reference
From where data/document is obtainable
elbahmani74@gmail.com
R.hoseini@razi.ac.ir
What processes are involved for a request to access data/document
If the explanation for data request would be convincing it will be given in 3 days.