Study of the effect of TRX Suspension Training on Functional Balance, Postural Control, Proprioception and Knee Muscles Isometric Strength in Patients With Multiple Sclerosis
The effect of TRX suspension training on functional balance, postural control, proprioception and knee muscles isometric strength in patients with Multiple Sclerosis
Design
Clinical trial with control group, Non randomized and purposive, single blind
Settings and conduct
The intervention group performed TRX suspension training for 8 weeks at the Sports Club of the Isfahan MS association. All measurements were carried out at the laboratory of faculty of Sport Sciences in University of Isfahan and faculty of Rehabilitation Sciences of Isfahan University of Medical Sciences. The testers were blinded to the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Expanded Disability Status Scale (EDSS) score of 1-4,
Female gender and non-pregnancy,
Age range between 20-50 years,
Not having another acute or chronic disabling diseases contrary with exercise and the medical prohibition for performing the exercise.
Complete the written informed consent
Exclusion criteria:
Relapse the disease during the study,
Pregnancy of subjects during the study,
Did not tend to continue the exercise or attend in research,
Did not complete the pre-test and post-test
Intervention groups
The intervention group received the TRX suspension training for 8 weeks. The control group received their usual daily activities
Main outcome variables
Functional capacity in patients with multiple sclerosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180521039762N1
Registration date:2018-06-10, 1397/03/20
Registration timing:retrospective
Last update:2018-06-10, 1397/03/20
Update count:0
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Afshin Moghadasi
Name of organization / entity
University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 3793 4208
Email address
afshin.moghadasi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-09-23, 1396/07/01
Trial completion date
empty
Scientific title
Study of the effect of TRX Suspension Training on Functional Balance, Postural Control, Proprioception and Knee Muscles Isometric Strength in Patients With Multiple Sclerosis
Public title
The Effect of TRX Suspension Training on Functional Capacity in Patients With Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Expanded Disability Status Scale (EDSS) score of 1-4
Female gender and non-pregnancy
Age range between 20-50 years
Not having another acute or chronic disabling diseases contrary with exercise
The medical prohibition for performing the exercise
Complete the written informed consent
Exclusion criteria:
Relapse the disease
Pregnancy of subjects during the study
Did not complete the pretest and post test
Did not tend to continue the exercise or attend in research
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
35
Actual sample size reached:
34
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The tester was blinded to each subject’s control and intervention groups
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the University of Isfahan
Street address
University of Isfahan, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.UI.REC.1396.014
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
Functional balance
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Forward and lateral functional reach tests; Timed up & go test; Timed 25‐foot walk test.
2
Description
Knee proprioception (joint position sense) error
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Biodex isokinetic dynamometer
3
Description
Isometric maximal voluntary contractions
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Biodex isokinetic dynamometer
4
Description
Quality of Life
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
MSQoL-54 questionnaire
5
Description
Postural control
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Force plate system
6
Description
Walking endurance
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Two-minute walk tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group performed the TRX suspension training program, included eight TRX whole-body workout with four levels of difficulty for every exercise that lasted for 8 weeks, 3 sessions per week and 30 minutes each session. Each of the training levels included three sets with 5, 7 and 10 repetitions.The ratio of rest to practice was 3 to 1.
Category
Rehabilitation
2
Description
Control group: The control group received their usual daily activities.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
انجمن ام. اس اصفهان
Full name of responsible person
Afshin Moghadasi
Street address
Robut Ave, Isfahan MS association
City
Isfahan
Province
Isfehan
Postal code
---
Phone
+98 31 3346 2490
Email
Afshin.moghadasi@yahoo.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
نهاد حمایت کننده دانشگاه اصفهان هست نه علوم پزشکی
Full name of responsible person
Rasoul Roknizadeh
Street address
Hezarjarib Ave, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2171
Email
rokni@sci.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
نهاد حمایت کننده دانشگاه اصفهان هست نه علوم پزشکی
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
با سلام حقیر دانشجوی دانشگاه اصفهان هستم نه علوم پزشکی
Full name of responsible person
Afshin Moghadasi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Sciences, Sport Injury & Corrective Exercises
Street address
Hezarjarib Ave, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 4208
Email
afshin.moghadasi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Afshin Moghadasi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Sciences, Sport Injury & Corrective Exercises
Street address
University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 4208
Fax
Email
afshin.moghadasi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahanعنوان انگلیسی دانشگاه اصفهان صحیح می باشد
Full name of responsible person
Afshin Moghadasi
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Sport Sciences, Sport Injury & Corrective Exercises
Street address
University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 4208
Fax
Email
afshin.moghadasi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Training protocol and all collected data can be shared
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academic institutions and patients with multiple sclerosis
Under which criteria data/document could be used
In order to research and on condition of cooperation
From where data/document is obtainable
Afshin moghadasi
What processes are involved for a request to access data/document
Information is available after contact with Mr. Afshin Moghadasi and coordination with the Department of Sport Injury & Corrective Exercises of the University of Isfahan.