Assessing the effect of exercise training on physical fitness, joint range of motion and quality of life in women patients with multiple sclerosis
Design
Randomized clinical trial with control group, non blinded, with parallel groups
Settings and conduct
Among patients with multiple sclerosis that covered by the Welfare Organization, thirty volunteers woman that have expanded disability status scale more than 1.5 and less than 6, will be selected as the study population and will randomly (Lottery) divide into three aerobic- resistance training, aerobic- resistance- balance training and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: women patients suffering from multiple sclerosis, have an expanded disability status scale more than 1.5 and less than 6
Exclusion criteria: have any physical and mental problems that limit their participation in the training. For example: cardiovascular disease and cognitive disorder
Intervention groups
Aerobic-resistance training group: 8- weeks, three times per week, each session include incremental aerobic (at 40-60% of Heart rate reserve) and resistance (at 60-80% of 1RM) training
Aerobic-resistance-balance training group: 8- weeks, three times per week, each session include incremental aerobic (at 40-60% of Heart rate reserve) and resistance (at 60-80% of 1RM) training and 15 min balance training
Control group: no intervention
Main outcome variables
Physical fitness; joint range of motion; quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150531022498N20
Registration date:2018-03-26, 1397/01/06
Registration timing:retrospective
Last update:2018-03-26, 1397/01/06
Update count:0
Registration date
2018-03-26, 1397/01/06
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-21, 1395/06/31
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
2016-09-21, 1395/06/31
Actual recruitment end date
2016-10-21, 1395/07/30
Trial completion date
empty
Scientific title
Effect of exercise training on physical fitness, joint range of motion and quality of life in women patients with multiple sclerosis
Public title
Effect of exercise training in women patients with multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Have an expanded disability status scale 1.5-6
Have age ranges 28-40 years
Be women
Patient suffering from multiple sclerosis
Exclusion criteria:
Have any physical and mental problems that limit their participation in the training (including cardiovascular disease and cognitive disorder)
Age
From 28 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Assigning samples using simple random-lottery method
Blinding (investigator's opinion)
Not 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 Islamic Azad University Rasht Branch
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Approval date
2016-09-17, 1395/06/27
Ethics committee reference number
IR.IAU.RASHT.REC.1395.27
Health conditions studied
1
Description of health condition studied
Women with multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Physical fitness
Timepoint
Before and after the end of eight weeks
Method of measurement
Using by measuring muscle strength, aerobic power and balance
2
Description
Joint range of motion
Timepoint
Before and after the end of eight weeks
Method of measurement
Using by goniometer
3
Description
Quality of life
Timepoint
Before and after the end of eight weeks
Method of measurement
Using by quality of life questionnaire (SF-36)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 8-weeks incremental aerobic- resistance training, including three 6-10 min sets at 40-60% of reverse heart rate and three 10 min sets of 60-80% of one repetition maximum
Category
Lifestyle
2
Description
Intervention group: 8-weeks incremental aerobic- resistance training combined with balance training, including three 6-10 min sets at 40-60% of reverse heart rate, three 10 min sets of 60-80% of one repetition maximum and 15 min static and ballistic balance training
Category
Lifestyle
3
Description
Control group: no intervention will be conducted
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
State Welfare Organization of Guilan Province
Full name of responsible person
Sepideh Jafari Sayadi
Street address
State Welfare Organization of Guilan Province, Parastar Street, Rasht, Guilan
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3333 3595
Email
sepidehjafarisayadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delpasand
Street address
Islamic Azad University Rasht Branch, Taleshan Bredge
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3385 6174
Email
shabani_msn@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Personality, Researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sepideh Jafari Sayadi
Position
MA
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3375 2715
Email
sepidehjafarisayadi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ramin Shabani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3375 2715
Email
shabani_msn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Izaddoust
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3385 6174
Email
fa.izaddoust@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available