Protocol summary

Summary
Objective: The aim of this study was to compare the efficacy of an 8-week balance, resistance and combined (balance- resistance) exercise program on balance, gait, and quality of life in women with M.S. Design: design of this study was pre test post test and single blind. Setting and conduct: Thirty women with M.S (mean±SD: age 35.33±3.2) were randomely divided into balance, resistance and combined exercise groups. The Berg balance test, gait distance in 6 minutes and MSQOL-54 questionnaire were used respectively evulation of balance, gait and quality of life. Patients underwent a 3 separate intervention protocols for 8 weeks. The one way analysis of variance, Tukey and paired t tests were used for statistical analysis (P<0.05). Participants including major eligibility criteria: To be eligible for inclusion in the study, participants had to have received a laboratory-supported diagnosis of relapsing-remitting, secondary progressive or primary progressive MS. In addition, they had to meet the following criteria: 1) competence to give informed consent, 2) age between 30 and 40 years, 3) ability to walk 25 feet with or without a cane or bracing, and 4) ability to verbalize a willingness to comply with the study's evaluation schedule. The exclusion criteria were as follows: 1) inability to provide informed consent, 2) EDSS score of 7 or higher, 3) inability to walk 25 feet with the use of an assistive device, 4) pregnancy, breastfeeding, or having given birth within 3 months of initiation of the study, and 5) diagnosis of any other neurologic disorder or disability that would affect balance and mobility. Interventions: eight weeks resistance, balance and combined (resistance- balance) training. Main outcome measures: balance, gait and quality of life. Blinnding: traines were learning only their own group and each group was blind about the training protocol of another group. trainers and resercher were blind about effects of these protocols on desired factors.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017053134257N1
Registration date: 2017-06-15, 1396/03/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-15, 1396/03/25
Registrant information
Name
maryam mohamazadeh
Name of organization / entity
kish international campus
Country
Iran (Islamic Republic of)
Phone
+98 76 4443 0023
Email address
mohammadzadeh@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
investivator
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-12-19, 1395/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical trial comparing the effect of eight weeks resistance, balance and combined (resistance- balance) training program on balance, gait and quality of life in patients with Multiple Sclerosis
Public title
Comparison the efficacy of eight weeks resistance, balance and combined (resistance- balance) training program on balance, gait and quality of life in patients with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
To be eligible for inclusion in the study, participants had to have received a laboratory-supported diagnosis of relapsing-remitting, secondary progressive or primary progressive MS. In addition, they had to meet the following criteria: competence to give informed consent; age between 30 and 40 years; ability to walk 25 feet with or without a cane or bracing; ability to verbalize a willingness to comply with the study's evaluation schedule. The exclusion criteria were as follows: inability to provide informed consent; EDSS score of 7 or higher; inability to walk 25 feet with the use of an assistive device; pregnancy, breastfeeding, or having given birth within 3 months of initiation of the study; diagnosis of any other neurologic disorder or disability that would affect balance and mobility.
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
wemen with a history of MS for at least three years, EDSS between one and four, reffering to Shaygan nejad ' Clinic that were volentire to attend in this research were devided in three groups randomely. Randomization: The patients will be randomly in three groups

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
tehran university ethic committee
Street address
pardis international campus
City
kish
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
489579

Health conditions studied

1

Description of health condition studied
multiple sclerosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
balance, gait and quality of life
Timepoint
balance(Prior to intervention and after 8 weeks intervention); gait (Prior to intervention and after 8 weeks intervention); quality of life(Prior to intervention and after 8 weeks intervention)
Method of measurement
Berg balance test, gait distance in 6 minutes and MSQOL-54 questionnaire

Secondary outcomes

1

Description
none
Timepoint
none
Method of measurement
none

Intervention groups

1

Description
in this study we have 3 Exercise interventions. First intervention group performed 8 weeks of Balance exercise for 3 times in week on the supervision of investigator. 2nd intervention group performed 8 weeks of resistance exercise for 3 times in week on the supervision of investigator. 3rd intervention group performed 8 weeks of combined balance anr resistance exercise for 3 times in week on the supervision of investigator. Resistance exercise intervention
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
isfahan ms center
Full name of responsible person
Dr Vahid Shayegannezhad
Street address
p 25;felestin Sq;Ferdosi St,Hakim Tower, Isfahan
City
isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
investivator
Full name of responsible person
maryam mohammadzadeh
Street address
university of tehran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
investivator
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
kharazmi university
Full name of responsible person
amir letafatkar
Position
professor
Other areas of specialty/work
Street address
mirdamad.sout razan st. sport sciences faculty
City
tehran
Postal code
00982122258084
Phone
+98 21 2225 8084
Fax
Email
letafatkaramir@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
isfahan university
Full name of responsible person
dr nader rahnama
Position
professor
Other areas of specialty/work
Street address
University of isfahan- sport sciences faculty
City
isfahan
Postal code
00989132943148
Phone
+98 132943148
Fax
Email
rahnamanader@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
kish international campus
Full name of responsible person
maryam mohamadzadeh
Position
phd student
Other areas of specialty/work
Street address
kish international campus
City
kish
Postal code
Phone
+98 912 719 0095
Fax
Email
mohammadzadeh@ut.ac.irshimamohamadi1396@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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