View older revisions Content changed at 2024-06-05, 1403/03/16

Protocol summary

Study aim
The general aim is to determine the effect of lower limb strength training with and without blood flow restriction on strength, balance and knee proprioception in people with patellofemoral pain syndrome.
Design
Simple random sampling individually into two intervention groups and a control group of 36 patients
Settings and conduct
Training place: gym and training with front leg machine and leg press. Testing place: Biomechanics laboratory of Bahnar University (Biodex machine, hand dynamometer, photogrammetry)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men and women suffering from femoral patellofemoral pain syndrome with an age range of 18 to 40 years pain with any activity, including running, jumping, squatting, kneeling, climbing/descending stairs, or prolonged sitting; pain with patellar pressure; touching the area around the patella; and pain in sitting position with resistance to isometric knee extension Positive patellar grind (or inhibition) test exclusion criteria: Having a concomitant injury around the knee, including patellar laxity or dislocation and other causes of anterior knee pain (bursa, fat pad) having diabetes History of knee surgery in the past year If the subject does not have the necessary cooperation to do the exercises. The subject has pain during the exercises.
Intervention groups
The first group: strength exercises with 30% of maximum strength (leg extension machine and leg press machine) with blood circulation restriction Second group: strength exercises with 70% of maximum strength ( leg extension machine and leg press machine) without blood circulation restrictions Control group: no training
Main outcome variables
lower limb strength training with and without blood flow restriction on muscle strength in knee extension movement; the balance; The proprioception of people with patellofemoral pain syndrome has a different effect.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180627040251N6
Registration date: 2023-08-01, 1402/05/10
Registration timing: prospective

Last update: 2024-06-05, 1403/03/16
Update count: 1
Registration date
2023-08-01, 1402/05/10
Registrant information
Name
Hassan Sadeghi
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8001
Email address
hassan.sadeghi81@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-16, 1402/05/25
Expected recruitment end date
2023-09-21, 1402/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of lower limb resistance exercises with and without blood flow restriction on muscle strength, balance, and knee proprioception, in people with patellofemoral pain syndrome
Public title
Comparison the Effect of lower limb resistance exercises with and without blood flow restriction on muscle strength, balance, and knee proprioception, in people with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between the ages of 18 and 40 with femoral patellofemoral pain syndrome pain with any activity, including (running, jumping, squatting, kneeling, climbing/descending stairs, or long sitting) pain with patellar pressure; Touching the area around the patella Pain in sitting position with resistance to isometric knee extension Positive Patellar grinding test
Exclusion criteria:
Having an injury around the knee, including a laxity or dislocation of the patella Knee ligament and meniscus injuries Other knee injuries such as osteoarthritis of the knee, Osgoodschlatter syndrome or Sinding-Larsen-Johnson or tendinopathy of the muscles around the knee
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized into one of three groups (Two interventions and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport Sciences Research Institute (SSRI)
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-06-21, 1402/03/31
Ethics committee reference number
IR.SSRC.REC.1402.053

Health conditions studied

1

Description of health condition studied
Knee pain
ICD-10 code
M22.2
ICD-10 code description

2

Description of health condition studied
Patellofemoral disorders
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders

Primary outcomes

1

Description
Muscle strength
Timepoint
immediately before intervention; immediately after intervention
Method of measurement
Dynamometer

Secondary outcomes

1

Description
Balance
Timepoint
before intervention; immediately after intervention
Method of measurement
Biodex Balance System

2

Description
Knee proprioception
Timepoint
before intervention; immediately after intervention
Method of measurement
Goniometer

3

Description
Visual Analogue Scale
Timepoint
before intervention; immediately after intervention
Method of measurement
Score of 100 mm visual analog scale to assess pain intensity

Intervention groups

1

Description
The first intervention group: This group includes patients with anterior knee pain (patellofemoral pain syndrome) who are found to be treatable with physical therapy after initial examination. This group of patients has the ability to perform movements as determined by their doctor. The exercises of these people include strength exercises (front leg machine, machine leg press) with 30% of the maximum strength, which are performed with 60% arterial occlusion pressure, by closing a pneumatic cuff around the thigh for 8 weeks and 3 times a week. The exercises of this group are one set of 30 repetitions (or voluntary exhaustion), then three sets of 15 repetitions. Also, rest between sets is 30 seconds and between exercises is 2 minutes.
Category
Rehabilitation

2

Description
The second intervention group: This group includes patients with anterior knee pain (patellofemoral pain syndrome) who, after the initial examination, have been determined to be treatable with physiotherapy. This group of patients has the ability to perform movements as determined by their doctor. Exercises in this group include strength training (front leg press, machine leg press) with three sets of 7 to 10 repetitions (approximately 70% of 1RM) with BFR placebo. The placebo is a 5 cm elastic cuff that is placed tightly (with enough space for two fingers between the skin and the cuff) around the proximal thigh. This does not affect the number of repetitions performed during strength training in the initial test. Rest between sets is 30 seconds and between exercises is 2 minutes.
Category
Rehabilitation

3

Description
Control group: In the control group, there is no intervention and only pre-test and post-test are taken. They are asked not to exercise during this time.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Physical Education, Shahid Bahoner University, Kerman
Full name of responsible person
Mina Bahrami
Street address
Faculty of sport sciences, Shahid Bahonar University, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۴۳۹
Phone
+98 34 3132 3177
Email
minabahrami8564@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Mohammad Delnavaz
Street address
Vice-Chancellor for Research and Technology. No. 43. South Mofatteh Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
15719-14911
Phone
+98 21 2222 8001
Fax
Email
Delnavaz@khu.ac.ir
Web page address
https://research.khu.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kharazmi 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
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Fax
Email
hassan.sadeghi81@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Fax
Email
hassan.sadeghi81@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hassan Sadeghi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Mirdamad - Shahid Hesari St. - Shahid Keshvari Complex - Faculty of Physical Education and Sports Sciences
City
Tehran
Province
Tehran
Postal code
33111-15447
Phone
+98 21 2222 8001
Fax
Email
hassan.sadeghi81@yahoo.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...