- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07917559
EFFECT OF ADDING BLOOD FLOW RESTRICTION TRAINING TO CLOSED CHAIN EXERCISE IN KNEE OSTEOARTHRITIS
Knee osteoarthritis is a common joint condition that causes knee pain, stiffness, muscle weakness, and difficulty performing daily activities such as walking, climbing stairs, and standing up from a chair. Exercise therapy is commonly used to improve muscle strength, reduce pain, and restore physical function. However, some patients may find traditional strengthening exercises difficult because of pain and increased stress on the knee joint.
Blood flow restriction (BFR) training is a rehabilitation technique that uses a specialized cuff placed around the upper thigh to partially restrict blood flow during exercise. This technique may help improve muscle strength while using lighter exercise loads.
The purpose of this study is to investigate whether adding blood flow restriction training to traditional physical therapy and closed kinetic chain exercises provides additional benefits for patients with knee osteoarthritis.
This randomized controlled trial will include 60 male and female participants aged 40 to 60 years with mild to moderate knee osteoarthritis. Participants will be randomly assigned to one of two groups, with 30 participants in each group.
The first group will receive traditional physical therapy exercises combined with closed kinetic chain exercises, such as mini-squats, step-ups, step-downs, partial lunges, and wall slides.
The second group will receive the same exercise program with the addition of blood flow restriction training.
Both groups will participate in supervised treatment sessions twice weekly for eight weeks, for a total of 16 sessions.
The researchers will assess knee pain, knee range of motion, quadriceps muscle strength, knee function, mobility and fall risk, quality of life, and patient satisfaction. Assessments will be conducted before treatment, immediately after the eight-week intervention, and one month after completing treatment.
The study aims to determine whether adding blood flow restriction training to closed kinetic chain exercises can improve rehabilitation outcomes in individuals with knee osteoarthritis.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
Knee osteoarthritis (KOA) is a chronic degenerative joint disorder characterized by progressive cartilage deterioration, pain, stiffness, reduced muscle strength, and functional limitations. Quadriceps muscle weakness is a major contributing factor to impaired knee stability and reduced physical performance in individuals with knee osteoarthritis.
Closed kinetic chain (CKC) exercises are commonly used in knee osteoarthritis rehabilitation because they involve functional weight-bearing movements that promote coordinated muscle activation, joint stability, and neuromuscular control. However, conventional resistance training may be difficult for patients who experience pain or cannot tolerate high mechanical loads.
Blood flow restriction (BFR) training is a rehabilitation approach that involves applying a pneumatic cuff to the proximal thigh during low-load exercise. By partially restricting blood flow, BFR training may stimulate muscular adaptations while reducing the need for high external resistance.
This study will investigate the effectiveness of adding blood flow restriction training to closed kinetic chain exercises in patients with mild to moderate knee osteoarthritis.
Study Design:
This study will be conducted as a randomized controlled trial involving 60 male and female participants diagnosed with mild to moderate knee osteoarthritis (Kellgren-Lawrence grades II-III).
Participants will be aged between 40 and 60 years and have a body mass index ranging from 25 to 29.9 kg/m².
Eligible participants will be recruited from outpatient physical therapy clinics in Cairo, Egypt.
Participants will be randomly allocated into two equal groups using a computer-generated randomization method.
Intervention:
Group A (Control Group):
Thirty participants will receive a traditional therapeutic exercise program combined with closed kinetic chain exercises.
Traditional exercises will include seated knee extensions, hip adduction and abduction exercises, straight leg raises, short-arc knee extensions, ankle pumps, and hamstring curls.
Closed kinetic chain exercises will include mini-squats, step-ups, step-downs, partial lunges, and wall slides.
Group B (Experimental Group):
Thirty participants will receive the same traditional and closed kinetic chain exercise program with the addition of blood flow restriction training.
Blood flow restriction will be applied using a specialized pneumatic cuff positioned around the proximal thigh during low-load resistance and closed kinetic chain exercises.
Both groups will receive 16 supervised treatment sessions over eight weeks, with two sessions per week.
Outcome Assessment:
The effectiveness of the interventions will be evaluated using the following measures:
- Pain intensity using the Numeric Pain Rating Scale (NPRS).
- Knee range of motion using a smartphone-based digital inclinometer.
- Quadriceps muscle strength using a hand-held dynamometer.
- Knee function using the Knee Injury and Osteoarthritis Outcome Score (KOOS).
- Functional mobility and fall risk using the Timed Up and Go (TUG) test.
- Health-related quality of life using the Short Form-36 (SF-36) questionnaire.
- Patient satisfaction using the Patient Satisfaction Questionnaire Short Form (PSQ-18).
Outcome assessments will be performed at baseline, immediately after the eight-week intervention, and at a one-month follow-up.
The study will compare changes in clinical and functional outcomes between the two groups to determine whether adding blood flow restriction training provides additional therapeutic benefits compared with traditional and closed kinetic chain exercises alone.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Rasha A Khattab, MSc
- Puhelinnumero: +201129635873
- Sähköposti: mf1952004@gmail.com
Opiskelupaikat
-
-
Cairo Governorate
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Cairo, Cairo Governorate, Egypti, 11511
- Outpatient Physical Therapy Clinics in Cairo, Egypt
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Ottaa yhteyttä:
- Rasha A Khattab, Master Degree
- Puhelinnumero: +201129635873
- Sähköposti: mf1952004@gmail.com
-
Päätutkija:
- Rasha A Khattab, MSc
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
Participants diagnosed with mild to moderate knee osteoarthritis (Kellgren-Lawrence grades II-III).
Participants aged between 40 and 60 years.
Body mass index (BMI) ranging from 25 to 29.9 kg/m².
Presence of chronic knee pain for at least three months.
Pain intensity of ≥3/10 on the Visual Analog Scale (VAS) or equivalent WOMAC pain score.
Ability to ambulate independently and perform closed kinetic chain exercises.
Participants who are medically fit to participate in low-load resistance exercise with or without blood flow restriction training.
Willingness to participate and provide written informed consent.
Exclusion Criteria:
History of knee surgery within the previous 12 months.
Presence of severe knee osteoarthritis (Kellgren-Lawrence grade IV).
Diagnosis of inflammatory joint diseases, such as rheumatoid arthritis.
Presence of cardiovascular, vascular, or neurological disorders that contraindicate blood flow restriction training.
Participation in any other structured lower limb strengthening or blood flow restriction training program during the study period.
Cognitive impairment or inability to understand and follow exercise instructions.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Traditional Exercise and Closed Kinetic Chain Exercises
Participants in the control group will receive a traditional therapeutic exercise program combined with closed kinetic chain exercises, including seated knee extensions, hip adduction and abduction, straight leg raises, short-arc knee extensions, ankle pumps, hamstring curls, mini-squats, step-ups, step-downs, partial lunges, and wall slides. Treatment will be delivered twice weekly for eight weeks, for a total of 16 supervised sessions. |
A supervised therapeutic exercise program consisting of traditional strengthening exercises and closed kinetic chain exercises, including mini-squats, step-ups, step-downs, partial lunges, and wall slides. The program will be performed twice weekly for eight weeks. |
|
Kokeellinen: Blood Flow Restriction Training Combined with Closed Kinetic Chain Exercises
Participants in the experimental group will receive the same traditional therapeutic exercise and closed kinetic chain exercise program as the control group, with the addition of blood flow restriction training. Blood flow restriction will be applied using a pneumatic cuff positioned around the proximal thigh during low-load resistance or closed kinetic chain exercises. Treatment will be delivered twice weekly for eight weeks, for a total of 16 supervised sessions. |
A supervised therapeutic exercise program consisting of traditional strengthening exercises and closed kinetic chain exercises, including mini-squats, step-ups, step-downs, partial lunges, and wall slides. The program will be performed twice weekly for eight weeks. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Knee Pain Intensity Measured by the Numeric Pain Rating Scale (NPRS)
Aikaikkuna: Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Knee pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Changes from baseline will be assessed after treatment and at follow-up. |
Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
|
Change in Knee Range of Motion Measured by a Smartphone Digital Inclinometer
Aikaikkuna: Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Knee joint range of motion will be measured in degrees using a smartphone-based digital inclinometer application. Knee flexion and extension angles will be assessed to evaluate changes in joint mobility following the intervention. Changes from baseline will be evaluated at week 8 and week 12. |
Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
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Change in Quadriceps Muscle Strength Measured by a Hand-Held Dynamometer
Aikaikkuna: Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Quadriceps muscle strength will be assessed using a hand-held dynamometer to measure isometric muscle force during voluntary contraction. The assessment will be performed using standardized testing procedures. Changes in quadriceps muscle strength from baseline will be evaluated after treatment and at follow-up. |
Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Knee Function Measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Aikaikkuna: Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Knee-related function will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS), a 42-item questionnaire covering five subscales: pain, symptoms, activities of daily living, sport and recreation, and knee-related quality of life. Each subscale is transformed to a score ranging from 0 to 100, with higher scores indicating better knee-related outcomes. |
Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
|
Change in Functional Mobility Measured by the Timed Up and Go (TUG) Test
Aikaikkuna: Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Functional mobility will be assessed using the Timed Up and Go (TUG) test. Participants will be instructed to stand up from a chair, walk three meters, turn around, return to the chair, and sit down. The time required to complete the task will be recorded in seconds. Lower completion times indicate better functional mobility. |
Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
|
Change in Health-Related Quality of Life Measured by the Short Form-36 (SF-36)
Aikaikkuna: Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Health-related quality of life will be assessed using the Short Form-36 (SF-36) questionnaire, which consists of 36 items evaluating physical and mental health domains. Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Changes from baseline will be evaluated following treatment and at follow-up. |
Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
|
Change in Patient Satisfaction Measured by the Patient Satisfaction Questionnaire (PSQ-18)
Aikaikkuna: Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Patient satisfaction with healthcare services will be assessed using the Patient Satisfaction Questionnaire Short Form (PSQ-18). The questionnaire contains 18 items covering seven dimensions: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with the healthcare provider, and accessibility and convenience. Items are rated using a five-point Likert scale. |
Baseline, week 8 (post-treatment), and week 12 (one-month follow-up).
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Rasha A Khattab, MSc, Cairo University, Faculty of Physical Therapy
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Li Y, Fu S, Zhang D, Liu M, Liu H. Effect of low-intensity resistance training at different levels of blood flow restriction on pain, proprioception and muscle strength in patients with knee osteoarthritis: a randomized controlled trial. BMC Musculoskelet Disord. 2025 Aug 8;26(1):769. doi: 10.1186/s12891-025-09051-7.
- Michael HJ, Pham HD, Li LSK, Semciw AI, Scholes MJ, Hannington M, King MG. The Efficacy of Closed Versus Open Kinetic Chain Exercise in Knee Osteoarthritis-A Systematic Review and Meta-Analysis. Physiother Res Int. 2025 Oct;30(4):e70105. doi: 10.1002/pri.70105.
- Lin Q, Yu D, Zhang Y, Chen X, Qin J, Wu F. Impact of low-load blood flow restriction training on knee osteoarthritis pain and muscle strength: a systematic review and meta-analysis of randomized controlled trials. Front Physiol. 2025 Mar 17;16:1524480. doi: 10.3389/fphys.2025.1524480. eCollection 2025.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- BFR training on Osteoarthritis
- P.T.REC/012/006531 (Muu tunniste: Cairo University, Faculty Of Physical Therapy Research Ethical Committee)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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