Protocol summary

Summary
1) Objectives: As, physiological effects of eccentric exercise on the muscle performance has been shown in several studies in normal subjects, compared to concentric exercise, this study has been designed to investigate the special effect of these two type exercise in the patients with multiple sclerosis . 2) Design: Randomized clinical trial. 3) Setting and conduct: Concentric (walking on a treadmill with positive slope) and eccentric (walking on a treadmill with negative slope) exercise protocols were designed for experimental groups. 4) Participants including major eligibility criteria: 30 patients with multiple sclerosis will be participated according to the inclusion criteria including; ability to walk 10 meter in a less than 1 minute (with or without aim) and exclusion criteria including; sever decrease of functional ability during last year, Pregnancy, Corticosteroid treatment during last month, Sever Psychological condition, Any conditions cause to prevent mild or moderate sport activities, regular sport activity twice a week for more than 10 minutes in each session, simultaneously present another medical condition such as diabetic, lower limb arthritis, unstable cardiovascular conditions. 5) Intervention: The exercise protocol (concentric or eccentric exercise) included 30 minutes walking on treadmill within 55% of Maximum Heart rate which progressively increase to 85% Maximum Heart rate , for 12 sessions, 3 times a week. 6) Main outcome: a) Functional activity evaluations: including Two-Minute Walk، Timed 25 Foot Walk and Timed Get-up and Go, b) Static and dynamic balance indexes, c) Maximum isometric Torque of the left and right quadriceps and hamstring muscles, d) Disability and Ability index by completing Guy’s Neurological Disability Scale and Rivermead Mobility Index.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107261254N7
Registration date: 2011-11-05, 1390/08/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-11-05, 1390/08/14
Registrant information
Name
Amir Hoshang Bakhtiary Davijani
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1444 1983
Email address
amirbakhtiary@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2011-09-20, 1390/06/29
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effect of Eccentric and Concentric Exercises to improve Function, Balance and Muscle Strength in Patients with Multiple Sclerosis
Public title
The Comparison of the Effect of Eccentric and Concentric Exercises to improve Function, Balance and Muscle Strength in Patients with Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Multiple Sclerosis patients with ability to walk 10 meter in a less than 1 minute (with or without aim) exclusion Criteria: Sever decrease of functional ability during last year; Pregnancy; Corticosteroid treatment during last month, Sever Psychological condition, Any conditions cause to prevent mild or moderate sport activities; regular sport activity twice a week for more than 10 minutes in each session; simultaneously present another medical condition such as diabetic; lower limb arthritis; unstable cardiovascular conditions that cause noncooperation of subject during intervention
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Blv Basij
City
Semnan
Postal code
Approval date
2011-10-26, 1390/08/04
Ethics committee reference number
90/111350

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Two-Minute Walk
Timepoint
Before and after intervention and also after 4 weeks follow-up
Method of measurement
By meter

2

Description
Timed 25 Foot Walk
Timepoint
Before and after intervention and also after 4 weeks follow-up
Method of measurement
By chronometer

3

Description
Timed Get-up and Go
Timepoint
Before and after intervention and also after 4 weeks follow-up
Method of measurement
By Chronometer

4

Description
Static Balance Index
Timepoint
Before and after intervention and also after 4 weeks follow-up
Method of measurement
By Biodex Balance System

5

Description
Dynamic Balance Index
Timepoint
Before and after intervention and also after 4 weeks follow-up
Method of measurement
By Biodex Balance System

6

Description
Maximum isometric torque of quadriceps muscles
Timepoint
Before and after intervention and also after 4 weeks follow-up
Method of measurement
By Biodex Isokinetic Device 4Pro

7

Description
Maximum isometric torque of hamstring muscles
Timepoint
Before and after intervention and also after 4 weeks follow-up
Method of measurement
By Biodex Isokinetic Device 4Pro

Secondary outcomes

1

Description
Disability Rate
Timepoint
Before and after intervention and also after 4 weeks follow-up
Method of measurement
Guy’s Neurological Disability Scale

2

Description
Ability rate
Timepoint
Before and after intervention and aslo after 4 weeks follow-up
Method of measurement
Rivermead Mobility Index (RMI)

Intervention groups

1

Description
30 minutes walking on treadmill with Positive slope (Concentric group), 3 times in a week, 4 weeks
Category
Rehabilitation

2

Description
30 minutes walking on treadmill with negative slope (Eccentric group), 3 times a week, 4 weeks
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Centre
Full name of responsible person
Dr Amir H Bakhtiary
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blv.
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Semnan University of Medical Sciences, Basij Blv.
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Semnan University of Medical Sciences
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
Semnan University of Medical Sciences
Full name of responsible person
Amir Hoshang Bakhtiary
Position
PhD in Physiotherapy/ Associate Professor
Other areas of specialty/work
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blv.
City
Semnan
Postal code
Phone
+98 23 1332 8502
Fax
Email
amirbakhtiary@sem-ums.ac.ir; amir822@gmail.com; amir822@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Amir Hoshang Bakhtiary
Position
PhD in physiotherapy/ Associate Professor
Other areas of specialty/work
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blv.
City
Semnan
Postal code
Phone
+98 23 1332 8502
Fax
Email
amirbakhtiary@sem-ums.ac.ir
Web page address

Person responsible for updating data

Contact

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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