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

NCT ID: NCT06502587

Last Updated: 2024-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-23

Study Completion Date

2024-07-20

Brief Summary

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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.

Detailed Description

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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. Both groups will receive Ultrasound therapy for 7 minutes, as common treatment. Group A will be treated with Blood flow restriction training with low intensity exercises and Group B will be treated with baseline treatment only. 3 sessions per week and total 12 sessions for 4 weeks. The outcome measures will be conducted through NPRS, Womac index for osteoarthritis,kellgren and lawrence scale and goniometry before and after 4 weeks. Data will be analyzed using SPSS software version 26.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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blood flow restriction training

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.

Group Type EXPERIMENTAL

blood flow restriction training

Intervention Type 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

ultrasound application only

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

Group Type ACTIVE_COMPARATOR

ultrasound therapy

Intervention Type 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

Interventions

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blood flow restriction training

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

Intervention Type OTHER

ultrasound therapy

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Iqra Khan, Mphil

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Lahore General Hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Imran Amjad

Role: CONTACT

03324390125

Facility Contacts

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Iqra Khan, Mphil

Role: primary

03354671744

References

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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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 32310159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32772865 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29266093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33582442 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 34549541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34391274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33727516 (View on PubMed)

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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 32030478 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/23/01112

Identifier Type: -

Identifier Source: org_study_id

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