The effect of 12-week combined exercise training on motor and muscular function, degree of disability, fatigue and quality of life in Multiple Sclerosis patients
The purpose of this study was to investigate the effect of concurrent training on muscular performance, fatigue and quality of life in patients with multiple sclerosis (MS). 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. All participants had regular menstrual cycles and had never participated in any regular exercise training before the beginning of the study. The training protocol included one session of resistance exercise and two sessions of aerobic exercise per week for 12 weeks. The main dependent variables of this study were muscular performance, fatigue and the quality of life. In this study was not done blinding
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042133146N2
Registration date:2017-08-21, 1396/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-21, 1396/05/30
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-week combined exercise training on motor and muscular function, degree of disability, fatigue and quality of life in Multiple Sclerosis patients
Public title
Strength and resistance training in Multiple Sclerosis patients
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 50 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, Tehran road, Sabzevar University of Medical Sciences
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
Motor and Muscular Function
Timepoint
Before and after the intervention
Method of measurement
Use special test of speed, endurance and power for patients
2
Description
Fatigue
Timepoint
Before and after the intervention
Method of measurement
Fatigue Questionnaire
3
Description
Quality of life
Timepoint
Before and after the intervention
Method of measurement
Quality of life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: combined exercise training(aerobic, resistance ), included three sessions per week, lasting for 12 weeks(two sessions of aerobic training and one session of resistance training)
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, Hospital Vasei
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
Razi University
Full name of responsible person
Mohammad Joshaghani, Vice Chancellor for research of ...Razi University
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?
Yes
Title of funding source
Razi University
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
Razi University
Full name of responsible person
Mitra Khademosharie
Position
Exercise Physiology, phd
Other areas of specialty/work
Street address
Opposite the oil depot, Police Square, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4465 9021
Fax
Email
m_khadem_un@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate Professor of Exercise Physiology
Other areas of specialty/work
Street address
University Avenue, taq-e Bostan, Razi University, Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 3427 7605
Fax
Email
vtadibi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Mitra Khademosharie
Position
phd student
Other areas of specialty/work
Street address
University Avenue, taq-e Bostan, Razi University, Kermanshah
City
Kermanshah
Postal code
Phone
+98 51 4465 9021
Fax
Email
m_khadem_un@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)