Protocol summary

Study aim
The effect of six weeks of low-intensity blood flow restriction exercises on pain and performance in kayakers with chronic shoulder pain
Design
A randomized clinical trial with parallel groups on 24 patients
Settings and conduct
The current research plan is in the form of two groups of12 qualified people with intervention. People are first evaluated to evaluate the range of motion the Mobi Mod device,strength and proprioception by the Biodex device and then the intervention will be implemented on both groups and the effects of the interventions will be compared between the two groups. These evaluations will be done in the laboratory of Shahid Beheshti University.
Participants/Inclusion and exclusion criteria
Inclusion criteria: membership in the rowing board of Tehran, having a history of chronic pain, any type of scapula dyskinesia, women and men with an age range of17to25 years, having body mass index less than25,no history of surgery in the neck, shoulder and chest area, no medical contraindications; Exclusion criteria: excessive shoulder pain, inability to perform pre-test and post-test, high blood pressure, open fracture
Intervention groups
Intervention group1:People will perform an exercise program with an intensity of 20 to 25% of maximum times for 6 weeks and 3 days a week.(These exercises will be accompanied by blood flow restriction(BFR).) Intervention group2:Individuals will perform an exercise program with an intensity of 20-25% of the maximum load for6 weeks and 3days a week.(without BFR)
Main outcome variables
Range of motion,strength,Proprioception

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230405057826N1
Registration date: 2023-09-03, 1402/06/12
Registration timing: retrospective

Last update: 2023-09-03, 1402/06/12
Update count: 0
Registration date
2023-09-03, 1402/06/12
Registrant information
Name
Farnaz Shojaee Bolvardi
Name of organization / entity
The university of Doctor Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 5245
Email address
f.shojaeibolvardi@mail.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-30, 1402/02/10
Expected recruitment end date
2023-07-01, 1402/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of six weeks of low-intensity blood flow restriction exercises on pain and performance in kayakers with chronic shoulder pain: clinical trial
Public title
The effect of six weeks of resistance training with blood flow restriction on pain and function in chronic shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Membership of rowers in rowing committee of Tehran province Having a history of chronic pain Having any kind of scapula dysknesia Men and women kayak rowers between 17 and 25 years old Having a body mass index less than 25 Not having a history of surgery in the neck, shoulder and chest area Absence of any medical contraindications for carrying out a resistance training program with blood flow restriction, based on the doctor's approval
Exclusion criteria:
excessive shoulder pain high blood pressure inability to perform pre-test and post-test open fracture
Age
From 17 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random - Lottery (in this method, the researcher pours numbered paper into a container and shakes it according to the number of people in the society. Then each athlete chooses a paper and their number is noted. Odd numbers are divided into intervention group 1 and even numbers are divided into intervention group 2
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
Ethics committee of shahid beheshti University
Street address
Ethics committee, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2023-03-07, 1401/12/16
Ethics committee reference number
IR.SBU.REC.1402.014

Health conditions studied

1

Description of health condition studied
chronic shoulder pain
ICD-10 code
M25.51
ICD-10 code description
Pain in shoulder

Primary outcomes

1

Description
strength
Timepoint
2 days before the start of the intervention and 2 days after the end of the intervention
Method of measurement
Biodex Systems(for measure strength )

2

Description
Proprioception
Timepoint
2 days before the start of the intervention and 2 days after the end of the intervention
Method of measurement
Biodex Systems(for measure Proprioception)

3

Description
Range of motion
Timepoint
2 days before the start of the intervention and 2 days after the end of the intervention
Method of measurement
mobee med (for measure Range of motion)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: After coordinating and reviewing the records and evaluating and completing the questionnaire, people will be selected to implement the exercise program and then after receiving a written consent form and a form to collect the subjects' information, including age, sports history, etc. these people will be invited to participate in this research. The general plan for intervention group 1 is that people spend 10 minutes each session for warming up and about 30 minutes of resistance training* (exercise with low intensity (20-25% of maximum load)) which for group 1 along with restrictions blood flow (using Anhuma brand device) and finally they perform stretching exercises for 5 minutes. The training period will be six weeks, 3 days a week.
Category
Rehabilitation

2

Description
Intervention Group 2: After coordinating and reviewing the records and evaluating and completing the questionnaire, people will be selected to implement the exercise program and then after receiving a written consent form and a form to collect the subjects' information, including age, sports history, etc. These people will be invited to participate in this research. The general plan for the intervention group 2 is that the participants spend 10 minutes each session for warming up and about 30 minutes of resistance training* (exercise with low intensity (20 to 25% of the maximum load)), which is without blood flow restriction for group 2, and finally they perform stretching exercises for 5 minutes. The training period will be six weeks, 3 days a week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran Rowing Board
Full name of responsible person
Sara Abdolmaleki
Street address
Rowing Board Federation .,Azadi sports complex .,Ali Daei Boulevard.,Hijazi Highway., Karaj
City
Tehran
Province
Tehran
Postal code
1484813111
Phone
+98 21 4473 9022
Email
info@azadisportcomplex.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Afshar Jafari
Street address
Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5824
Email
af_jafari@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University
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
Shahid Beheshti University
Full name of responsible person
Fariborz Hovanlo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
physical education
Street address
Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
‏shahid Beheshti University
Full name of responsible person
Fariborz Hovanlo
Position
‏Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
physical education
Street address
Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Fariborz Hovanlo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
physical education
Street address
Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information about the subjects is personal and will not be shared with others.
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
No - There is not 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 information except the subjects' personal information.
When the data will become available and for how long
Six months after the results are published
To whom data/document is available
All researchers.
Under which criteria data/document could be used
The use of research results is unimpeded by acquiring the source.
From where data/document is obtainable
f.shojaeibolvardi@mail.ac.ir
What processes are involved for a request to access data/document
At least two working days.
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