Protocol summary

Study aim
The Effect of 6 weeks of Combined Rehabilitation Program (electrical stimulation and isometric contraction) on pain and function in athletes with knee osteoarthritis
Design
The clinical trial consisted of three experimental group and a control group, with parallel and random groups. The Random allocation software was used for randomization
Settings and conduct
The present study is a quasi-experimental research with a pretest-posttest design with three experimental groups and one control group. 32 Athletes with Knee Osteoarthritis are randomly divided into four test and control groups. Pain and performance variables are measured before and after exercise.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having mild to moderate primary osteoarthritis, male gender, not having any arthroscopic surgery; Exclusion criteria: taking painkillers and anti-inflammatory drugs, participating in any exercise program at least six months before the research
Intervention groups
The first intervention group includes athletes with knee osteoarthritis who receive electrical stimulation intervention. The second intervention group includes athletes with knee osteoarthritis who receive isometric contraction intervention. The third intervention group includes athletes with osteoarthritis of the knee who receive the intervention of electrical stimulation and isometric contraction. The control group includes athletes with osteoarthritis of the knee who do not receive the intervention.
Main outcome variables
Pain and Performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200107046035N10
Registration date: 2022-06-28, 1401/04/07
Registration timing: prospective

Last update: 2022-06-28, 1401/04/07
Update count: 0
Registration date
2022-06-28, 1401/04/07
Registrant information
Name
Hossein Shahrokhi
Name of organization / entity
Hakim Sabzevari University
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 2756
Email address
h.shahrokhi@hsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of 6 weeks of Combined Rehabilitation Program (electrical stimulation and isometric contraction) on pain and function in athletes with knee osteoarthritis
Public title
The Effect of Combined Rehabilitation Program on pain and function in athletes with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate primary osteoarthritis Male Gender Do not have any arthroscopic surgery Lack of musculoskeletal disease in other parts of the body
Exclusion criteria:
Taking painkillers and inflammation Arthritis Participate in any exercise program at least six months prior to research
Age
From 45 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
The simple Randomization Method was used to assign individuals to 4 groups that in this method, Random Allocation Software was used to create a random sequence. Then, in order not to determine which group the individuals will be assigned to before dividing them into two groups, or in other words, allocation concealment, the central randomization method was used.
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
Sport sciences research institute
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2022-04-20, 1401/01/31
Ethics committee reference number
IR.SSRC.REC.1401.010

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Pain
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention
Method of measurement
Visual Analogue Scale

2

Description
Function
Timepoint
At the beginning of the study (before the start of the intervention) and after 6 weeks of intervention
Method of measurement
6-min walk test and Stair climb and descent and 40m (4x10m) Fast Paced Walk Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Electrical stimulation, for 6 weeks, 3 sessions per week, 2 hour per session
Category
Treatment - Other

2

Description
Intervention group: Isometric contraction, for 6 weeks, 3 sessions per week, 2 hour per session
Category
Treatment - Other

3

Description
Intervention group: Electrical stimulation and Isometric contraction, for 6 weeks, 3 sessions per week, 2 hour per session
Category
Treatment - Other

4

Description
Control group: Without any training and just doing normal daily activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafagh University
Full name of responsible person
Seyed Arman Nikoo
Street address
20th Mordab Ave, Nashtaroud
City
Tonekabon
Province
Qazvin
Postal code
4683165363
Phone
+98 11 5426 6957
Email
eli1400140014001400@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shafagh University
Full name of responsible person
Mohammad Fallahmohamadi
Street address
20th Mordab Ave
City
Nashtarood
Province
Mazandaran
Postal code
4683165363
Phone
+98 11 5426 6957
Email
info@shafagh.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shafagh University
Proportion provided by this source
10
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Tohid Shahr - Sabzevar - Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Tohid Shahr - Sabzevar - Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Hakim Sabzevari University
Full name of responsible person
Hossein Shahrokhi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Corrective Exercise
Street address
Tohid Shahr - Sabzevar - Iran
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617976487
Phone
+98 51 4401 2756
Fax
Email
h.shahrokhi@hsu.ac.ir

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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start the access period one year after printing the results
To whom data/document is available
Data will be available to academic and scientific researchers
Under which criteria data/document could be used
Any kind of functional analysis on the submitted data is allowed
From where data/document is obtainable
by Email: h.shahrokhi@hsu.ac.ir
What processes are involved for a request to access data/document
by Email: h.shahrokhi@hsu.ac.ir and the reason for using the documents
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