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BFRBFRNCT06565754

Effect of Adding Blood Flow Restriction to Strengthening Exercise in Patients With Patellofemoral Pain Syndrome

A study testing BFR and strengthening exercise in people with BFR and PFPS, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To study the effect of adding BFRT to strengthening exercises and compare it with strengthening exercises alone in improving, muscular strength, pain, function, joint position sense, and dynamic balance test (star excursion test). in patients with PFPS. Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
BFR, PFPS, Strengthening Exercises
What is being tested?
BFR and strengthening exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteEgypt
Study dates
1 Sep 2024to 1 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient referred from Orthopedic surgeon with diagnosis of patellofemoral pain syndrome PFPS.
  • Both genders.
  • BMI ranges from 18.5 to 29.9.
  • Age ranges between 18 and 40 years experienced non-traumatic PFPS onset of anterior knee pain for greater than 2 weeks.
  • Pain with any two activities, including running, jumping, squatting, kneeling, stair ascent/descent or prolonged sitting.

Who cannot join

  • Coexisting pathology around the knee, including patellar subluxation or dislocation.
  • Other sources of anterior knee pain (bursa, fat pad).
  • Previous knee surgery.
  • Suspicion of patellar tendinopathy, with strong consideration of pain localised to the patellar tendon.
  • Any cardiovascular disease.
  • Uncontrolled hypertension.
Show all 10Show fewer
  • Any lower limb trauma.
  • Hip and ankle pathology.
  • BMI more than 30%.
  • Pregnancy.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo University

    Giza, 12613

    enas F youssef, Professor, +201127867507, enas.fawzy@pt.cu.edu.eg

    abdelgalil A shaaban, PhD, +201146937036, abdelgalildr@gmail.com

Other trials in Egypt

About this study

To study the effect of adding BFRT to strengthening exercises and compare it with strengthening exercises alone in improving, muscular strength, pain, function, joint position sense, and dynamic balance test (star excursion test). in patients with PFPS.

Read the detailed description

Background: Patellofemoral Pain Syndrome (PFPS) is a common condition characterized by anterior knee pain, particularly affecting individuals aged 15-30. It often involves lower limb muscle weakness, particularly in the quadriceps, which can exacerbate symptoms and affect functional performance. Blood Flow Restriction Training (BFRT) has shown promise in enhancing muscle strength and functional outcomes with reduced intensity compared to traditional high-intensity training.

Purpose: This study aims to compare the efficacy of combining BFRT with traditional strengthening exercises versus using strengthening exercises alone in improving muscular strength, pain, function, joint position sense, and dynamic balance in patients with PFPS.

Methods: A triple-blinded, randomized controlled trial was conducted at the Almenshawy General Hospital, Tanta, Egypt. Fifty patients with unilateral non-traumatic PFPS, aged 18-35, were randomly assigned to either a strengthening exercises group (SE Group) or a BFRT plus strengthening exercises group (BFRT Group). Both groups underwent a 6-week intervention with three sessions per week. Outcomes assessed included quadriceps and hip abductors strength, pain severity (Visual Analog Scale), functional status (Kujala Patellofemoral Score), joint position sense (measured by digital inclinometer), and dynamic balance (Star Excursion Balance Test).

Being tested
BFR, strengthening exercise
Keywords
PFPS, Patellofemoral Pain Syndrome, Blood Flow Restriction Training, Strengthening Exercises, Dynamic Balance
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BFROther

    Blood flow restriction training is an accessory to a variety of different exercise modes (e.g., resistance exercise, walking, cycling) has recently become a popular research topic. It involves the application of pressurized cuffs to the proximal portion of each lower extremity or upper extremity. It enhance blood pooling in the capillary beds of the limb muscles distal to the tourniquet or cuff.

    The 3rd Generation SmartCuffs® pump (SmartCuffs® 3.0 PRO) is Personalized Pressure feature which allows for a fast, hassle-free personalized pressure calculation. With the built-in pressure sensor and on-board computer, it is calculate arterial occlusion pressure and set the optimal pressure for patient's body. There is no need for an external doppler probe or hand pump. This unit will do everything for patient. Smart Cuffs 3rd generation is FDA Approved Listed Class 1 device.

    The automatized tourniquet (Smart Tools) contains a ring-shaped single- chamber

  • strengthening exerciseOther

    Quadriceps strengthening exercises are part of the treatment of PFPS, but the heavy resistance exercises may aggravate knee pain. Blood flow restriction training (BFRT) provides a low-load quadriceps strengthening method to treat PFPS (Giles et al., 2017).

Study groups in NCT06565754
Study groupRoleWhat they receive
strengthening exercises group (SE Group)Active comparatorall patients will receive : 1. Isometric quadriceps exercise - 3 sets of 20 repetitions (5 s). 2. Straight leg raise (SLR) with 3 sets - 20 repetitions. 3. Short arc knee extension exercise - 3 sets of 20 repetitions. 4. Hip abduction from side lying - 3 sets of 20 repetitions.
Receives: Other: strengthening exercise
BFRT plus strengthening exercises group (BFRT Group)Experimentalall patients will receive the below exercises using BFR cuff : 1. Isometric quadriceps exercise - 3 sets of 20 repetitions (5 s). 2. Straight leg raise (SLR) with 3 sets - 20 repetitions. 3. Short arc knee extension exercise - 3 sets of 20 repetitions. 4. Hip abduction from side lying - 3 sets of 20 repetitions.
Receives: Other: BFR; Other: strengthening exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. quadriceps and hip abductors strength

    Hand-Held Dynamometer (HHD). The Lafayette® HHD is a valid and reliable instrument of low cost and easy handling compared to the isokinetic dynamometer for assessment of muscle strength

    Measured: 6 weeks

Secondary outcomes (4)
  1. pain severity using Visual Analog Scale (VAS)

    The Visual Analog Scale is determined by measuring in millimeters from the left end of the line to the patient's mark. Participants will ask to determine the point at which pain represents the severity of pain maximum is 10 while lowest level of pain is zero

    Measured: 6 weeks

  2. functional status (Kujala Patellofemoral Score)

    The 13 items on the scale are used to assess subjective symptoms and functional restrictions. A score can have a minimum of 0 points or a maximum of 100 points.

    Measured: 6 weeks

  3. joint position sense (measured by digital inclinometer)

    Digital Inclinometer for joint position sense assessment. Device (Digital Protractor, 82201b-00, INSPEC, China) The inclinometer is a valid and reliable method to assess the knee proprioception through JPS in open kinetic chain

    Measured: 6 weeks

  4. dynamic balance (Star Excursion Balance Test

    Four strips of adhesive tape will need to be cut to a length of 6-8 feet each. Two pieces will be used to form a '+', with the other two being placed over top to form an 'x' so that a star shape is formed. It is important that all lines are separated from each other by a 45° angle. The goal of the Star Excursion Balance Test (SEBT) is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06565754
Sponsor's protocol ID
P.T.REC/012/005148
Other IDs
P.T.REC/012/005148
Acronym
BFR
Status last verified
Aug 2024
First submitted
26 Jul 2024
Last updated
22 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Stefanov F, Morris L, Elhelali A, Kavanagh EP, Lundon V, Hynes N, Sultan S. Insights from complex aortic surgery with a Streamliner device for aortic arch repair (STAR). J Thorac Cardiovasc Surg. 2016 Nov;152(5):1309-1318.e5. doi: 10.1016/j.jtcvs.2016.06.043. Epub 2016 Jun 29.

    PubMed 27485677
  • Sigaud O, Stulp F. Policy search in continuous action domains: An overview. Neural Netw. 2019 May;113:28-40. doi: 10.1016/j.neunet.2019.01.011. Epub 2019 Feb 5.

    PubMed 30780043
  • Golbs A, Nimmervoll B, Sun JJ, Sava IE, Luhmann HJ. Control of programmed cell death by distinct electrical activity patterns. Cereb Cortex. 2011 May;21(5):1192-202. doi: 10.1093/cercor/bhq200. Epub 2010 Oct 21.

    PubMed 20966045
  • Panneton WM, Gan Q, Juric R. The rat: a laboratory model for studies of the diving response. J Appl Physiol (1985). 2010 Apr;108(4):811-20. doi: 10.1152/japplphysiol.00600.2009. Epub 2010 Jan 21.

    PubMed 20093670
  • Wang H, Li Y, Zhang C, Han Y, Zhang X, Zhu T, Li T. Immunological and virological responses to cART in HIV/HBV co-infected patients from a multicenter cohort. AIDS. 2012 Sep 10;26(14):1755-63. doi: 10.1097/QAD.0b013e328355ced2.

    PubMed 22614885
  • Zhang A, Mo X, Zhou N, Wang Y, Wei G, Chen J, Chen K, Ouyang P. A novel bacterial beta-N-acetyl glucosaminidase from Chitinolyticbacter meiyuanensis possessing transglycosylation and reverse hydrolysis activities. Biotechnol Biofuels. 2020 Jun 29;13:115. doi: 10.1186/s13068-020-01754-4. eCollection 2020.

    PubMed 32612678
  • Ziegler MG, Milic M, Lu X, Gharaibeh M, Elayan H. Effect of obstructive sleep apnea on the response to hypertension therapy. Clin Exp Hypertens. 2017;39(5):409-415. doi: 10.1080/10641963.2016.1259327. Epub 2017 May 30.

    PubMed 28557555
  • Herzog N, Hartkamp JD, Verheugd P, Treude F, Forst AH, Feijs KL, Lippok BE, Kremmer E, Kleine H, Luscher B. Caspase-dependent cleavage of the mono-ADP-ribosyltransferase ARTD10 interferes with its pro-apoptotic function. FEBS J. 2013 Mar;280(5):1330-43. doi: 10.1111/febs.12124. Epub 2013 Feb 13.

    PubMed 23305266
  • Barrett CL, Mann GE, Taylor PN, Strike P. A randomized trial to investigate the effects of functional electrical stimulation and therapeutic exercise on walking performance for people with multiple sclerosis. Mult Scler. 2009 Apr;15(4):493-504. doi: 10.1177/1352458508101320. Epub 2009 Mar 12.

    PubMed 19282417
  • Parnia S, Yang J, Nguyen R, Ahn A, Zhu J, Inigo-Santiago L, Nasir A, Golder K, Ravishankar S, Bartlett P, Xu J, Pogson D, Cooke S, Walker C, Spearpoint K, Kitson D, Melody T, Chilwan M, Schoenfeld E, Richman P, Mills B, Wichtendahl N, Nolan J, Singer A, Brett S, Perkins GD, Deakin CD. Cerebral Oximetry During Cardiac Arrest: A Multicenter Study of Neurologic Outcomes and Survival. Crit Care Med. 2016 Sep;44(9):1663-74. doi: 10.1097/CCM.0000000000001723.

    PubMed 27071068
  • Galvez-Martinez S, Mateo-Marti E. Ultraviolet Irradiation on a Pyrite Surface Improves Triglycine Adsorption. Life (Basel). 2018 Oct 25;8(4):50. doi: 10.3390/life8040050.

    PubMed 30366364
  • Saade Riachy C, Nemr E. Medical professionalism in Lebanon: between doctors' perception and patients' satisfaction. Int J Med Educ. 2020 Aug 21;11:171-172. doi: 10.5116/ijme.5f28.77a3. No abstract available.

    PubMed 32827248
  • Maher SK, Wojnarowicz P, Ichu TA, Veldhoen N, Lu L, Lesperance M, Propper CR, Helbing CC. Rethinking the biological relationships of the thyroid hormones, l-thyroxine and 3,5,3'-triiodothyronine. Comp Biochem Physiol Part D Genomics Proteomics. 2016 Jun;18:44-53. doi: 10.1016/j.cbd.2016.04.002. Epub 2016 Apr 7.

    PubMed 27085304
  • Ozbay B, Uzun K, Arslan H, Zehir I. Functional and radiological impairment in women highly exposed to indoor biomass fuels. Respirology. 2001 Sep;6(3):255-8. doi: 10.1046/j.1440-1843.2001.00339.x.

    PubMed 11555385
  • Martelletti P, Schwedt TJ, Lanteri-Minet M, Quintana R, Carboni V, Diener HC, Ruiz de la Torre E, Craven A, Rasmussen AV, Evans S, Laflamme AK, Fink R, Walsh D, Dumas P, Vo P. My Migraine Voice survey: a global study of disease burden among individuals with migraine for whom preventive treatments have failed. J Headache Pain. 2018 Nov 27;19(1):115. doi: 10.1186/s10194-018-0946-z.

    PubMed 30482181

Questions about this trial

What is this clinical trial studying?

A study testing BFR and strengthening exercise in people with BFR and PFPS, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ABDELRAHMAN M HEWID, MSc (9294358403 ext. 9294358403, dr.abdelrahman.hewidy.94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

quadriceps and hip abductors strength (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06565754, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.

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