Effects of Blood Flow Restriction Training With Low Intensity Exercises in Knee Osteoarthritis

NCT06502587 | Recruiting

• 1 other identifier: REC/RCR&AHS/23/01112
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria.

Conditions

Knee Osteoarthritis

Keywords

Blood flow restriction training; Knee Osteoarthritis; Pain; Quality of life; Range of motion

Outcome Measures

Primary Outcomes (1)

• NPRS Numeric pain rating scale

  The NPRS is a self-reported, or clinician administered, measurement tool consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form. The patient is asked to rate his/her pain intensity and a particular time frame or descriptor is established (e.g. within the last 24 h, today, worst pain, average pain, or least pain)

  4th week

Secondary Outcomes (3)

• Womac index for knee osteoarthritis

  4th week

• Knee Related QOL (QUALITY OF LIFE) Subscale From KOOS

  4th week

• Universal goniometer

  4th week

Study Arms (2)

blood flow restriction training

EXPERIMENTAL

we will apply blood flow restriction training with low intensity exercises on patients with knee osteoarthritis to check pain,quality of life and range of motion.

Other: blood flow restriction training

ultrasound application only

ACTIVE COMPARATOR

in this group we will apply ultrasound therapy on knee joint for 7 minutes.

Other: ultrasound therapy

Interventions

blood flow restriction training OTHER

we will apply blood flow restriction training with low intensity exercises like knee flexion ,knee extension and straight leg raise 10 repetitions 2 sets a day and 3 times/week a rest interval of 2 minutes between exercises, for 30 minutes of this whole procedure. total 12 sessions given in 4 weeks each session of maximum 30 minutes

blood flow restriction training

ultrasound therapy OTHER

All subjects will be given Ultrasound therapy as per patient requirement with 1.5 Watts/cm\^2 in continuous mode around knee joint. Conservative exercises(quads isometric exercise, pillow squeeze, heel raise, straight leg raise and side leg raise) will be applied for 3 times per week (daily one set of 10 repetitions) They will be given this treatment for 3 times per week

ultrasound application only

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both Male and Female age between 40 to 65 years diagnosed with womac ostearthritis index having acute knee pain.
• Patients with history of osteoarthritis (of grade 1 and 2 with KL(kellgren and Lawerence)) grading system for knee Osteoarthritis
• Pain in and around knee measuring through Numeric Pain rating Scale(NPRS)\>4(14)

You may not qualify if:

• hypertension
• diabetes
• sickle cell anemia
• renal compromise
• obesity
• open fracture,
• increased intracranial pressure
• pregnancy
• cancer or tumor,
• extremity with dialysis access,
• extremity fracture
• peripheral vascular compromise
• DVT(Deep vein thrombosis) \& pulmonary embolism deformity of hip \& back

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Lahore General Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (12)

• Prathap Kumar J, Arun Kumar M, Venkatesh D. Healthy gait: Review of anatomy and physiology of knee joint. International Journal of Current Research and Review. 2020;12(6):1-8.

  BACKGROUND

• Van Cant J, Dawe-Coz A, Aoun E, Esculier JF. Quadriceps strengthening with blood flow restriction for the rehabilitation of patients with knee conditions: A systematic review with meta-analysis. J Back Musculoskelet Rehabil. 2020;33(4):529-544. doi: 10.3233/BMR-191684.

  PMID: 32310159 BACKGROUND

• Ferlito JV, Pecce SAP, Oselame L, De Marchi T. The blood flow restriction training effect in knee osteoarthritis people: a systematic review and meta-analysis. Clin Rehabil. 2020 Nov;34(11):1378-1390. doi: 10.1177/0269215520943650. Epub 2020 Aug 10.

  PMID: 32772865 BACKGROUND

• Ferraz RB, Gualano B, Rodrigues R, Kurimori CO, Fuller R, Lima FR, DE Sa-Pinto AL, Roschel H. Benefits of Resistance Training with Blood Flow Restriction in Knee Osteoarthritis. Med Sci Sports Exerc. 2018 May;50(5):897-905. doi: 10.1249/MSS.0000000000001530.

  PMID: 29266093 BACKGROUND

• Grantham B, Korakakis V, O'Sullivan K. Does blood flow restriction training enhance clinical outcomes in knee osteoarthritis: A systematic review and meta-analysis. Phys Ther Sport. 2021 May;49:37-49. doi: 10.1016/j.ptsp.2021.01.014. Epub 2021 Feb 3.

  PMID: 33582442 BACKGROUND

• Kaya PDCBK, Alpozgen AZ. EFFECTS OF BLOOD FLOW RESTRICTION METHOD IN KNEE PATHOLOGIES. TAM METİN KİTABI. 2022:21.

  BACKGROUND

• Wang HN, Chen Y, Cheng L, Cai YH, Li W, Ni GX. Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Arthritis Care Res (Hoboken). 2022 Jan;74(1):89-98. doi: 10.1002/acr.24787. Epub 2021 Dec 17.

  PMID: 34549541 BACKGROUND

• Pitsillides A, Stasinopoulos D, Mamais I. Blood flow restriction training in patients with knee osteoarthritis: Systematic review of randomized controlled trials. J Bodyw Mov Ther. 2021 Jul;27:477-486. doi: 10.1016/j.jbmt.2021.04.015. Epub 2021 Apr 23.

  PMID: 34391274 BACKGROUND

• Li S, Shaharudin S, Abdul Kadir MR. Effects of Blood Flow Restriction Training on Muscle Strength and Pain in Patients With Knee Injuries: A Meta-Analysis. Am J Phys Med Rehabil. 2021 Apr 1;100(4):337-344. doi: 10.1097/PHM.0000000000001567.

  PMID: 33727516 BACKGROUND

• Mahmoud WS, Osailan A, Ahmed AS, Elnaggar RK, Radwan NL. Optimal parameters of blood flow restriction and resistance training on quadriceps strength and cross-sectional area and pain in knee osteoarthritis. Isokinetics and Exercise Science. 2021;29(4):393-402.

  BACKGROUND

• NADIA AF, ABDALLAH MM, FADEL MEM, MOHAMMED MM. Effect of Low Load Resistance Blood Flow Restriction Training on Knee Osteoarthritis. The Medical Journal of Cairo University. 2018;86(December):4297-306.

  BACKGROUND

• Rolff S, Korallus C, Hanke AA. [Rehabilitation with the aid of blood flow restriction training]. Unfallchirurg. 2020 Mar;123(3):180-186. doi: 10.1007/s00113-020-00770-1. German.

  PMID: 32030478 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Blood Flow Restriction Therapy; Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Diathermy; Hyperthermia, Induced

Study Officials

• Iqra Khan, Mphil

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 16, 2024
• Study Start: November 23, 2023
• Primary Completion: July 20, 2024
• Study Completion: July 20, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)