Comparison of the effect of 8 weeks of selected TRX and aerophytic exercises on central stability function, balance and depth of sensation in patients with MS
Comparison of the effect of 8 weeks of selected exercises with TRX and Irofitance on central stability function, balance and depth of sensation in patients with MS
Design
Clinical trials have two experimental groups with parallel groups, one-way blind, non-random, phase 2 on 40 patients. Data analysis using SPSS software and analysis of variance with repeated measurement schemes.
Settings and conduct
Two experimental groups, pre-test and post-test, exercise in the gym of Isfahan MS Association. Blindness has occurred in relation to data analyzers
Participants/Inclusion and exclusion criteria
1- Having a person with MS according to the diagnosis of a neurologist
2- EDSS between 1 and 4
3- Female gender and not being pregnant
4- Age range between 20 and 50
5 - Not being infected with other acute or chronic disabling diseases contrary to exercise
6- Non-prohibition of a specialist doctor to perform sports exercises
7- The desire to participate and complete the form of conscious consent to participate in the study
Intervention groups
Intervention Group 1: TRX Group, Intervention Group 2: Aerophytic Group. In the intervention group, 1 exercise was performed using TRX band for 8 weeks and about 2 and a half months. In the intervention group, 2 exercises were performed using Traband, Dumbbell, Wood and Ball for 8 weeks and about 2 and a half months.
Main outcome variables
Improved central stability function; improved balance; improved sense of depth in patients with MS with EDSS less than 5; See better results of TRX Group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200501047256N1
Registration date:2020-06-20, 1399/03/31
Registration timing:retrospective
Last update:2020-06-20, 1399/03/31
Update count:0
Registration date
2020-06-20, 1399/03/31
Registrant information
Name
Fatemeh Marjani
Name of organization / entity
Isfahan University of Sports Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5745 3630
Email address
fmarjani2913@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2018-09-09, 1397/06/18
Actual recruitment end date
2018-09-16, 1397/06/25
Trial completion date
2018-11-26, 1397/09/05
Scientific title
Comparison of the effect of 8 weeks of selected TRX and aerophytic exercises on central stability function, balance and depth of sensation in patients with MS
Public title
Comparison of the effect of TRX and aerophytic exercises on MS patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A person with MS has been diagnosed by a neurologist
EDSS between 1 and 4
Feminine sex and not being pregnant
Age range between 20 and 50
The willingness to participate and complete the form of conscious consent to participate in the study
Exclusion criteria:
Lack of exercise in other acute or chronic debilitating diseases
Non-prohibition of a specialist to perform exercises
Failure to complete pre-test research tests
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, using the randomization method, the block of individuals assigned to each group is almost equal and blocks are formed based on the considered variables.
How to build blocks: Subjects were divided into two equal groups by choosing their favorite sport based on their ability and interest.
In this research, the subjects were first given a written consent form to participate in the research.
Randomization tool: Random number table was used. And by the third person in different groups, including TRX training group (person 20) and Aerofitness training group (person 20), they were placed according to the entry and exit criteria of the research and received the intervention related to the same group.
There was no quasi-random and hidden method.
Blinding (investigator's opinion)
Single blinded
Blinding description
According to your explanation, we did not have blindness in the subjects, and only to make our statistical analysis correct, without personal comment, statistical analysis was performed and blinding was done only in relation to statistical analysis.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Sports Sciences
Street address
Hezar Jarib St., University of Isfahan, Central Library
City
Esfahan
Province
Isfehan
Postal code
8771656574
Approval date
2019-09-04, 1398/06/13
Ethics committee reference number
IR.UI.REC.1398.042
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
Measurement of central stability performance
Timepoint
Before training and 2 months after training
Method of measurement
Measurement of central stability function by lateral trunk tests, Sorenson and trunk flexors
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group 1: TRX Group. In the intervention group, 1 exercise was performed using the TRX band for 8 weeks, 3 sessions per week, each session 1 hour for about 2 and a half months. Exercises started with stability and continued with more advanced exercises over time and during subsequent sessions. In both groups, the balance, strength and endurance of the central muscles of individuals were practiced, and finally these two intervention groups were compared with each other and the performance of individuals in both groups was examined.
Category
Rehabilitation
2
Description
Intervention Group 2: Aerofitness Group. In Intervention Group 2, the exercises were performed using Traband, dumbbells, sticks and balls for 8 weeks, 3 sessions per week, each session 1 hour for about 2 and a half months. The exercises started from beginner and stable and continued with advanced exercises. In both groups, the balance, strength and endurance of the central muscles of individuals were practiced and finally these two intervention groups were compared with each other and the performance of individuals in both groups was examined.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Province MS Association
Full name of responsible person
Massoud Etemadifar
Street address
Bahonar Street
City
Esfahan
Province
Isfehan
Postal code
8154645731
Phone
+98 31 3273 1001
Fax
+98 31 3273 1080
Email
isfahan.salamat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan School of Sports Sciences
Full name of responsible person
Nader Rahnama
Street address
Hezar Jarib Street
City
Esfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2288
Fax
Email
moavenat-amouzeshi@dean.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan School of Sports Sciences
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
University of Esfahan
Full name of responsible person
Fatemeh Marjani
Position
coach
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Shahid Gharani street
City
Golpayegan
Province
Isfehan
Postal code
8771656574
Phone
+98 31 5745 3630
Email
f.marjani2913@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Esfahan
Full name of responsible person
Fatemeh Marjani
Position
coach
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Shahid Qarni Street
City
Golpayegan
Province
Isfehan
Postal code
8771656574
Phone
+98 31 5745 3630
Email
f.marjani2913@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Esfahan
Full name of responsible person
Fatemeh Marjani
Position
coach
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Shahid Qarni Street
City
Golpayegan
Province
Isfehan
Postal code
8771656574
Phone
+98 31 5745 3630
Email
f.marjani2913@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
No - There is not 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available