Protocol summary

Study aim
Investigating the immediate effect of low-load resistance training with blood flow restriction on pain and function in individuals with hamstring muscle strain
Design
Clinical trial with intervention and control groups, with parallel groups, single-blind, randomized by envelope, on 16 participants in a single session before and after.
Settings and conduct
athletes aged 20 to 40 who have suffered a hamstring strain invited to come to the clinic of the Faculty of Rehabilitation, University of Tehran. Participants are randomly assigned to an intervention and control group (using an envelope that only the researcher knows about the groupings). Each group performs the same exercises But closed cuffs have different pressures.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women in the age range of 20-40 years At least 2 weeks have passed since the person's hamstring strain. Exclusion criteria: History of blood clots, high blood pressure, acute infection, peripheral vascular problems and varicose veins, cancer, overweight.
Intervention groups
The intervention and comparison groups both include athletes with hamstring strain injuries and similar exercises are used in the intervention and the only difference in the intervention protocol of the two groups is that in the comparison group, only the cuffs are closed, but in the intervention group, according to the limb occolostion pressure, the cuffs are inflated to 80% of this pressure and the exercises are performed despite this pressure.
Main outcome variables
What is the average pain ،average hamstring muscle strength ، average passive knee extension amplitude average Active knee extension amplitude، average Timed Up and Go Test (TUG) before and after the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241227064184N1
Registration date: 2025-01-15, 1403/10/26
Registration timing: retrospective

Last update: 2025-01-15, 1403/10/26
Update count: 0
Registration date
2025-01-15, 1403/10/26
Registrant information
Name
Hooman Ahmadi Balef
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5593 4902
Email address
hoomanbalef@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-12-24, 1403/10/04
Expected recruitment end date
2025-01-06, 1403/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the effects of Low Load Resistance Training with Blood Flow Restriction on Pain and Function of individuals with Hamstring strain.
Public title
Low Load Resistance Training with Blood Flow Restriction of individuals with hamstring injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women in the age range of 20-40 years At least 2 weeks have passed since the person's hamstring strain No pain during the exercises so that the pain disappears for a few hours after the workout BMI under 30
Exclusion criteria:
History of blood clotting, blood pressure above 100/180, acute infection, peripheral vascular problems and varicose veins, cancer, hemorrhagic or thrombotic stroke, history of DVT, arterial fibrillation. The patient's unwillingness to continue treatment for any reason. The person has low back pain and lower extremity neuropathies. The person is in the acute phase and in pain.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
The method of randomization in this study is in the form of simple randomization and at the individual level and using sealed envelopes in two groups of 1 or 2 is as follows: 16 envelopes are prepared and in 8 envelopes the number 1 is written and in the other 8 envelopes the number 2 is written and these envelopes are moved in such a way that people know what number each envelope contains. They do not know and choose an envelope completely randomly, and after selecting that envelope, it is discarded and the next person makes his choice among the 15 envelopes, and in order to the end, people are placed in one of these two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
All participants are randomly divided into groups 1 or 2 using a sealed envelope, the person is not aware of which of the studied groups each group represents, and only the researcher is aware of which of these two groups is the control group and which is the intervention group. The only difference in the groups is the pressure in the cuffs during training, in which the intervention group performs the exercises using 80% of the pressure required to restrict blood flow in the lower extremities, and in the intervention group, only the cuffs are closed, and the only pressure is to the extent that the cuff does not descend from the limb. The participants do not train together at the same time, and the people do not know the amount of pressure in the other cuff, and the groups are quite similar in terms of the method of execution and appearance.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
school of nursing and midwifery of tehran university of medical sciences,east nosrat street,tohid square
City
tehran
Province
Tehran
Postal code
1419733171
Approval date
2024-12-22, 1403/10/02
Ethics committee reference number
IR.TUMS.FNM.REC.1403.172

Health conditions studied

1

Description of health condition studied
hamstring strain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity
Timepoint
Before and after the intervention
Method of measurement
It is measured using the Visual Analogue Scale (VAS) from 0 to 10.

Secondary outcomes

1

Description
Strength of the hamstring muscle
Timepoint
Before and after the intervention
Method of measurement
Using a dynamometer

2

Description
TUG mobility test
Timepoint
Before and after the intervention
Method of measurement
The time it takes for a person to get up from a sitting position, walk a distance of three meters, come back and sit again, which is measured using a stopwatch.

3

Description
Hamstring Length
Timepoint
Before and after the intervention
Method of measurement
The length of the hamstring muscles is measured using the active knee extension and passive knee extension test using a goniometer.

Intervention groups

1

Description
Intervention group: In this group, the intervention is done in the form of an open arch and the cuff is closed to the highest point of the thigh and the pressure is raised to the point that the sound of the artery is interrupted in Doppler ultrasound, which is called limb occolostion pressure (LOP). Then, using 80 percentage of that pressure, the desired exercise therapy is performed.
Category
Rehabilitation

2

Description
Control group: In this group, the intervention is done in the form of an open vault and the cuff is closed to the highest point of the thigh and the pressure is raised to the point that the sound of the artery is cut off in Doppler ultrasound, which is called limb occolostion pressure (LOP). In this group, unlike the intervention group, there is no compression in the cuffs, and only the cuffs are closed, and the desired exercise therapy is performed according to the protocol.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Hooman Ahmadi Balef
Street address
Faculty of Rehabilitation, Enghelab St., Shamiran Corner, Safi Alishah St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
rehabilitation@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zinat Ashnagar
Street address
Faculty of Rehabilitation, Enghelab St., Shamiran Corner, Safi Alishah St., Tehran, Iran
City
tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical 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
Tehran University of Medical Sciences
Full name of responsible person
Hooman Ahmadi Balef
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit.2, no.20, Astane street, Rey
City
Tehran
Province
Tehran
Postal code
1876733548
Phone
+98 21 5593 4902
Fax
Email
hoomanbalef@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hooman Ahmadi Balef
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit.2, no.20, Astane street, Rey
City
Tehran
Province
Tehran
Postal code
1876733548
Phone
+98 21 5593 4902
Fax
Email
hoomanbalef@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hooman Ahmadi Balef
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Unit.2, no.20, Astane street, Rey
City
Tehran
Province
Tehran
Postal code
1876733548
Phone
+98 21 5593 4902
Fax
Email
hoomanbalef@gmail.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
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
The individual data of the participants of this study as well as the data received from each person after the evaluation can be shared after de-identifying the person.
When the data will become available and for how long
Data access can be started 6 months after the results are published.
To whom data/document is available
These data will be available only to professors and students of academic and scientific institutions.
Under which criteria data/document could be used
The researcher working in academic or scientific institutions is allowed to use all the data by informing the administrators and researchers of this study and apply all types of statistical analysis on these data.
From where data/document is obtainable
To receive documents and data, they can send a message to my email address, hoomanbalef@gmail.com, or Ms. Sofia Naghdi naghdi@tums.ac.ir, my supervisor, so that we can guide them.
What processes are involved for a request to access data/document
The applicant must first introduce himself and state his academic and academic degree and give a clear explanation about his use of the documents to the presenters, then with the approval of Mr. Homan Ahmadi Balef or Mrs. Dr. Sofia Naghdi, the data will be sent to them.
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