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Effect of knee stabilization exercises with blood flow restriction on patellofemoral pain syndrome in bodybuilding athletes

Protocol summary

Study aim
The aim of this study is to examine the combination of knee stabilizing exercises with blood flow restriction on pain, balance, proprioception, strength, and knee kinematics in bodybuilder athletes with patellofemoral pain.
Design
The number of samples is 36 qualified subjects who are selected based on the criteria for Inclusion and exclusion criteria the research. The samples are divided into three training groups.
Settings and conduct
This is a semi-experimental and interventional research with three groups and pre- and post-test. The participants were randomly allocated into three different groups: Group 1 (control group, n=12), Group 2 (knee stabilization exercises, n=12), and Group 3 (knee stabilization exercises with BFR, n=12). The study is one-sided blind, so that the subjects will not be aware of the intervention of other groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: 1.Male participants aged between 18 to 28 years. 2.Experience of non-traumatic pain around or behind the patella for at least 4 weeks, with a minimum intensity of 3 centimeters on the Visual Analog Scale (VAS). 3.To induce pain, at least two functional activities including squatting, kneeling, prolonged sitting, stair climbing, jumping, or running must be repeated. Exclusion Criteria: 1.History or presence of meniscal, ligamentous, or other knee injuries and/or knee surgery. 2.Injuries such as knee osteoarthritis, Osgood-Schlatter disease, Sinding-Larsen-Johansson syndrome, or tendinopathy of the muscles around the knee.
Intervention groups
Group 1 (control group, n=12), Group 2 (knee stabilization exercises, n=12), and Group 3 (knee stabilization exercises with BFR, n=12)
Main outcome variables
Balance, Pain, Proprioception, Strength, Knee Kinematic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240603061996N1
Registration date: 2024-07-10, 1403/04/20
Registration timing: retrospective

Last update: 2024-07-10, 1403/04/20
Update count: 0
Registration date
2024-07-10, 1403/04/20
Registrant information
Name
abouzar saadatian
Name of organization / entity
Yasouj university
Country
Iran (Islamic Republic of)
Phone
+98 74 3100 1550
Email address
a.saadatian@yu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-17, 1400/08/26
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
2022-05-15, 1401/02/25
Actual recruitment end date
2022-06-20, 1401/03/30
Trial completion date
empty
Scientific title
Effect of knee stabilization exercises with blood flow restriction on patellofemoral pain syndrome in bodybuilding athletes
Public title
Effect of knee stabilization exercises with blood flow restriction on patellofemoral pain syndrome in bodybuilding athletes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Bodybuilding athletes with patellofemoral pain syndrome in rang age 18-28 years
Exclusion criteria:
History or current presence of meniscus, Ligament, or other knee injuries and/or knee surgery
Age
From 18 years old to 28 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization method will be used to assign participants to three groups. Random allocation software will be used to create random sequences. The central randomization method will also be used to hide the allocation concealment.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The subjects will be randomly assigned to one of the three study groups . The subjects will not be aware of the type of intervention of other groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Isfahan (Khorasgan) Branch
Street address
Faculty oof Nursing, Arghavanieh, Jey St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2022-11-06, 1401/08/15
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.22

Health conditions studied

1

Description of health condition studied
Patellofemoral Pain Syndrome
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain
Timepoint
The primary outcome measurement time points will be conducted before the intervention and 8 weeks after the intervention.
Method of measurement
Pain will be assessed using the Visual Analog Scale (VAS).

Secondary outcomes

1

Description
Balance, Proprioception, Strength, and Knee kinematics
Timepoint
The secondary outcome measurement time points will be conducted before the intervention and 8 weeks after the intervention.
Method of measurement
For assessment, the Y Balance Test will be used for dynamic balance, the Stork Test for static balance, a goniometer for proprioception, automated video analysis for dynamic systems to assess kinematics, and a handheld dynamometer for muscle strength.

Intervention groups

1

Description
Intervention group: The exercises include hip external rotation while lying on the side, hip external rotation while sitting on the table, step down, knee extension between 0 and 30 degrees, and isometric contraction with a ball(subjects hold a ball between their knee), they perform all exercises with 30% of 1RM. This training performed 6 weeks and 3 sessions per week (1 hour per session)
Category
Rehabilitation

2

Description
Control group: The traditional exercises include hip strengthening exercises and quadriceps strengthening exercises. The intensity of their exercise is in a comfortable and painless condition. This training performed 6 weeks and 3 sessions per week (1 hour per session)
Category
Rehabilitation

3

Description
Intervention group: The training programs with blood flow restriction (BFR) as described before were used in conjunction with blood flow occlusion during exercises. The Katsu device was used for blood flow occlusion. Arterial occlusion pressure was measured by placing a pneumatic cuff on the proximal thigh in a standing position. The cuff pressure was set to 120 mmHg at the beginning of the exercises (this pressure was chosen based on previous research results and the capability of the present study's participants, and the training load was adjusted accordingly). The cuff was removed 30 seconds after the last set of each exercise and reapplied before the first set of the next exercise. Note: Approximately 10% of the participants reported a pain level of 7 or 8. For these individuals, the training pressure was reduced according to the physician's advice, and the exercises were performed with lower pressure. Additionally, since all exercises were performed in the last 30 degrees of knee extension, the reaction force between the patella and femur was minimized, resulting in significantly less pain compared to daily activities. This training performed 6 weeks and 3 sessions per week (1 hour per session)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Laboratory of the Faculty of Sport Sciences, Islamic Azad University, Isfahan (Khorasgan) Branch, Is
Full name of responsible person
Erfan Ebad
Street address
Faculty of Physical Education and Sport Sciences, Arghavanieh , Jey St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 917 730 2800
Email
Aboozar.saadat67@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
faculty of Sport Sciences, Islamic Azad University,Khorasgan Branch, Isfahan, Iran
Full name of responsible person
Erfan Ebad
Street address
University Blvd, Arghavanieh, Jey St ,Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2000
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
faculty of Sport Sciences, Islamic Azad University,Khorasgan Branch, Isfahan, Iran
Proportion provided by this source
20
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
Yasouj university
Full name of responsible person
Abouzar saadatian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Sciences
Street address
Faculty of human science, Student Blvd,
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7493475918
Phone
+98 74 3100 1550
Email
Aboozar.saadat67@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University
Full name of responsible person
Abouzar Saadatian
Position
Assisstant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Department of Sport sciences, Faculty of human Sciences, Student street
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3100 1550
Fax
Email
a.saadatian@yu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yasouj university
Full name of responsible person
Abouzar Saadatian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Department Sport sciences, Faculty of Human Sciences, Student street
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591874934
Phone
+98 74 3100 1550
Fax
Email
a.saadatian@yu.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
After Completion of Interventions And Final Evaluation, The Data Will Be Shared Through The Articles To Provide a Comprehensive Treatment Process.
When the data will become available and for how long
The Results of This Study Will Be Available In Journals 6 Months After Publication
To whom data/document is available
The Results of The Studies Will Be Accessible to All Individuals in The Community Without Any Restrictions
Under which criteria data/document could be used
The Documentation Provided Can Be Applicable to Many Musculoskeletal Pain Syndromes as a Comprehensive Treatment Intervention That Considers Several Factors. These Interventions Are Applicable If Prescribed And Monitored By Physicists .
From where data/document is obtainable
Individuals Can Refer to The Islamic Azad University(khorasgan branch) Bookstore And Scientific Research Journals For Gaining Results.
What processes are involved for a request to access data/document
The Refer To The Islamic Azad University (khorasgan branch) Bookstore
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