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

NCT06565754 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005148
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BFR; PFPS; Strengthening Exercises; Quadriceps Strength; Dynamic Balance; Joint Position Sense

Keywords

PFPS; Patellofemoral Pain Syndrome; Blood Flow Restriction Training; Strengthening Exercises; Dynamic Balance

Outcome Measures

Primary Outcomes (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

  6 weeks

Secondary Outcomes (4)

• pain severity using Visual Analog Scale (VAS)

  6 weeks

• functional status (Kujala Patellofemoral Score)

  6 weeks

• joint position sense (measured by digital inclinometer)

  6 weeks

• dynamic balance (Star Excursion Balance Test

  6 weeks

Study Arms (2)

strengthening exercises group (SE Group)

ACTIVE COMPARATOR

all 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.

Other: strengthening exercise

BFRT plus strengthening exercises group (BFRT Group)

EXPERIMENTAL

all 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.

Other: BFR; Other: strengthening exercise

Interventions

BFR OTHER

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

BFRT plus strengthening exercises group (BFRT Group)

strengthening exercise OTHER

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).

BFRT plus strengthening exercises group (BFRT Group); strengthening exercises group (SE Group)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Any lower limb trauma.
• Hip and ankle pathology.
• BMI more than 30%.
• Pregnancy.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, 12613, Egypt

Location

Related Publications (27)

• 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.

  PMID: 27485677 BACKGROUND

• 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.

  PMID: 30780043 BACKGROUND

• 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.

  PMID: 20966045 BACKGROUND

• 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.

  PMID: 20093670 BACKGROUND

• 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.

  PMID: 22614885 BACKGROUND

• 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.

  PMID: 32612678 BACKGROUND

• 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.

  PMID: 28557555 BACKGROUND

• 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.

  PMID: 23305266 BACKGROUND

• 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.

  PMID: 19282417 BACKGROUND

• 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.

  PMID: 27071068 BACKGROUND

• 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.

  PMID: 30366364 BACKGROUND

• 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.

  PMID: 32827248 BACKGROUND

• 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.

  PMID: 27085304 BACKGROUND

• 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.

  PMID: 11555385 BACKGROUND

• 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.

  PMID: 30482181 BACKGROUND

• Esparza Martin N. [Hypotonic hiponatremia. Differential diagnosis]. Med Clin (Barc). 2016 Dec 2;147(11):507-510. doi: 10.1016/j.medcli.2016.09.013. Epub 2016 Oct 27. No abstract available. Spanish.

  PMID: 28126145 BACKGROUND

• Jagadeesh AT, Puttur A, Mondal S, Ibrahim S, Udupi A, Prasanna LC, Kamath A. Devising focused strategies to improve organ donor registrations: A cross-sectional study among professional drivers in coastal South India. PLoS One. 2018 Dec 21;13(12):e0209686. doi: 10.1371/journal.pone.0209686. eCollection 2018.

  PMID: 30576381 BACKGROUND

• Huijbers MG, Querol LA, Niks EH, Plomp JJ, van der Maarel SM, Graus F, Dalmau J, Illa I, Verschuuren JJ. The expanding field of IgG4-mediated neurological autoimmune disorders. Eur J Neurol. 2015 Aug;22(8):1151-61. doi: 10.1111/ene.12758. Epub 2015 May 29.

  PMID: 26032110 BACKGROUND

• Selak V, Webster R, Stepien S, Bullen C, Patel A, Thom S, Arroll B, Bots ML, Brown A, Crengle S, Dorairaj P, Elley CR, Grobbee DE, Harwood M, Hillis GS, Laba TL, Neal B, Peiris D, Rafter N, Reid C, Stanton A, Tonkin A, Usherwood T, Wadham A, Rodgers A. Reaching cardiovascular prevention guideline targets with a polypill-based approach: a meta-analysis of randomised clinical trials. Heart. 2019 Jan;105(1):42-48. doi: 10.1136/heartjnl-2018-313108. Epub 2018 Jun 28.

  PMID: 29954855 BACKGROUND

• Muoio R, Caretti C, Rossi L, Santianni D, Lubello C. Letter to the Editor: Water safety plans and risk assessment: A novel procedure applied to treated water turbidity and gastrointestinal diseases. Int J Hyg Environ Health. 2020 Aug;229:113455. doi: 10.1016/j.ijheh.2020.113455. Epub 2020 Jan 25. No abstract available.

  PMID: 31992522 BACKGROUND

• Nakao S, Platek A, Hirano S, Takeichi M. Contact-dependent promotion of cell migration by the OL-protocadherin-Nap1 interaction. J Cell Biol. 2008 Jul 28;182(2):395-410. doi: 10.1083/jcb.200802069. Epub 2008 Jul 21.

  PMID: 18644894 BACKGROUND

• Kasten P, Pape G, Raiss P, Bruckner T, Rickert M, Zeifang F, Loew M. Mid-term survivorship analysis of a shoulder replacement with a keeled glenoid and a modern cementing technique. J Bone Joint Surg Br. 2010 Mar;92(3):387-92. doi: 10.1302/0301-620X.92B3.23073.

  PMID: 20190310 BACKGROUND

• Froon-Torenstra D, Beket E, Khader AM, Hababeh M, Nasir A, Seita A, Benninga MA, van den Berg MM. Prevalence of functional constipation among Palestinian preschool children and the relation to stressful life events. PLoS One. 2018 Dec 6;13(12):e0208571. doi: 10.1371/journal.pone.0208571. eCollection 2018.

  PMID: 30521620 BACKGROUND

• Abe T, Kearns CF, Sato Y. Muscle size and strength are increased following walk training with restricted venous blood flow from the leg muscle, Kaatsu-walk training. J Appl Physiol (1985). 2006 May;100(5):1460-6. doi: 10.1152/japplphysiol.01267.2005. Epub 2005 Dec 8.

  PMID: 16339340 BACKGROUND

• Abe T, Fujita S, Nakajima T, Sakamaki M, Ozaki H, Ogasawara R, Sugaya M, Kudo M, Kurano M, Yasuda T, Sato Y, Ohshima H, Mukai C, Ishii N. Effects of Low-Intensity Cycle Training with Restricted Leg Blood Flow on Thigh Muscle Volume and VO2MAX in Young Men. J Sports Sci Med. 2010 Sep 1;9(3):452-8. eCollection 2010.

  PMID: 24149640 BACKGROUND

• Abbas MJ, Dancy ME, Marigi EM, Khalil LS, Jildeh TR, Buckley PJ, Gillett J, Burgos W, Okoroha KR. An Automated Technique for the Measurement of Limb Occlusion Pressure During Blood Flow Restriction Therapy Is Equivalent to Previous Gold Standard. Arthrosc Sports Med Rehabil. 2022 May 28;4(3):e1127-e1132. doi: 10.1016/j.asmr.2022.04.002. eCollection 2022 Jun.

  PMID: 35747637 BACKGROUND

• Penailillo L, Blazevich AJ, Nosaka K. Factors contributing to lower metabolic demand of eccentric compared with concentric cycling. J Appl Physiol (1985). 2017 Oct 1;123(4):884-893. doi: 10.1152/japplphysiol.00536.2016. Epub 2017 Jun 29.

  PMID: 28663378 RESULT

Related Links

• This review found that BFR significantly improves muscle strength but is less effective than heavy-load training . BFR is a viable and tolerable rehab tool, needing personalized
• The study examines how low-intensity cycling with and without blood flow restriction (BFR) impacts muscle strength, hypertrophy, and aerobic capacity, addressing whether BFR can simultaneously enhance both muscular and cardiovascular fitness.

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• enas F youssef, Professor

  Cairo University

  STUDY CHAIR

• abdelgalil A shaaban, PhD

  Cairo University

  STUDY DIRECTOR

• ahmed S helal, PhD

  Tanta University

  STUDY DIRECTOR

• ahmed M khalil, PhD

  Pharos University in Alexandria

  STUDY DIRECTOR

Central Study Contacts

ABDELRAHMAN M HEWID, MSc

CONTACT

9294358403; dr.abdelrahman.hewidy.94@gmail.com

ahmed M khalil, PhD

CONTACT

9294358403; ahmed.khalil@pua.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: August 22, 2024
• Study Start: September 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

EG (1)