The effect of 12-weeks combined exercise training on body composition, disability scale, and NGF, BDNF, and VDBP serum concentrations in women with multiple sclerosis
The purpose of this study was to investigate the effect of concurrent training on the Brain-derived Neurotrophic factor, Nerve growth factor and Vitamin D-binding protein serum concentrations in women with multiple sclerosis. Twenty four 20-50-year-old women with EDSS score of 2-5 were randomly divided into control (n=12) and experimental (n=12) groups, using random number function in excel. We didn’t have blinding in this study. All participants had regular menstrual cycles and had never participated in any regular exercise training before the beginning of the study. Inclusion criteria: EDSS score of 2 to 5 (approved by neurologist through MS diagnostic tests including MRI or CT scan and functional tests for balance, strength, walking ability, and visual and tactile senses); women aged between 20 and 50 years; regular menstrual cycle, absence of any other acute or chronic diseases; Not participating in any regular exercise training. The training protocol included one resistance exercise session and two aerobic exercise sessions per week for 12 weeks. The main dependent variables of this study were NGF, BDNF, and VDBP.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017032633146N1
Registration date:2017-08-11, 1396/05/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-11, 1396/05/20
Registrant information
Name
Vahid Tadibi
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 9265
Email address
vahidtadibi@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-03-20, 1393/12/29
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12-weeks combined exercise training on body composition, disability scale, and NGF, BDNF, and VDBP serum concentrations in women with multiple sclerosis
Public title
The effect of exercise training on women with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Inclusion criteria: EDSS score of 2 to 5 (approved by neurologist through MS diagnostic tests including MRI or CT scan and functional tests for balance, strength, walking ability, and visual and tactile senses); women aged between 20 and 50 years; regular menstrual cycle, donot presence of any other acute or chronic diseases; not participating in any regular exercise training.
Exclusion criteria: Did not have one of the condition of entry
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization was performed in the form random categorized and in each class, a simple randomization method was used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tehran-Sabzevar road
City
Sabzevar
Postal code
Approval date
2016-02-01, 1394/11/12
Ethics committee reference number
IR.MEDSAB.REC.1394.137
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
Nerve growth factor(NGF)
Timepoint
Before and after training
Method of measurement
ELISA Kit
2
Description
Brain-derived neurotrophic factor(BDNF)
Timepoint
Before and after training
Method of measurement
ELISA Kit
3
Description
Vitamin D-binding protein(VDBP)
Timepoint
Before and after training
Method of measurement
ELISA Kit
4
Description
Disability status scale
Timepoint
Before and after training
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combined exercise training included aerobic and resistance exercises, three sessions per week (two sessions of aerobic training and one session of resistance training), lasting 12 weeks.
Category
Rehabilitation
2
Description
Control group: had received no exercises and did their normal activities
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Disease Center, Vasei Hospital
Full name of responsible person
Maryam Bahram por
Street address
Special Disease Center, Vasei Hospital, Bagh Melli square, Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Razi University
Full name of responsible person
Mohammad Joshaghani
Street address
Central Building of Razi University, Bagh Abrisham, Taq Bostan, Kermanshah
City
Kermanshah
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?