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Effects of Intermittent Versus Continuous Blood Flow Restriction Training on Pain, Functional Ability, Muscle Strength and Exercise Perception Among Female Patients With Grade II Knee Osteoarthritis

20 de julio de 2026 actualizado por: Lahore University of Biological and Applied Sciences
This study holds significant clinical, academic, and practical importance in the field of musculoskeletal rehabilitation. Clinically, it addresses a critical need to identify an effective and tolerable strengthening strategy for females with early-stage knee osteoarthritis. By directly comparing intermittent and continuous BFR protocols, the findings will provide physiotherapists with evidence-based guidance for optimizing exercise prescription while minimizing discomfort and improving adherence.Academically, this research contributes to the limited body of literature comparing different BFR application strategies in knee osteoarthritis. The inclusion of exercise perception outcomes adds valuable insight into patient-centered rehabilitation, which is often underrepresented in clinical trials.From a practical and societal perspective, identifying a more tolerable BFR approach may enhance long-term exercise participation, delay disease progression, and reduce healthcare burden associated with knee osteoarthritis. The findings may also support the integration of low-load BFR training into rehabilitation programs in resource-limited clinical settings.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Knee osteoarthritis (KOA) is a chronic, progressive musculoskeletal disorder characterized by joint degeneration, pain, muscle weakness, and functional limitations, with a higher prevalence among middle-aged women. Quadriceps muscle weakness is a key clinical feature associated with reduced functional capacity and progression of the disease. Although high-load resistance training is considered effective for improving muscle strength, its application is often limited in symptomatic individuals due to increased joint loading and pain, thereby affecting adherence to rehabilitation programs.In recent years, low-load resistance training combined with Blood Flow Restriction (BFR) has gained attention as a viable alternative for enhancing muscle strength while minimizing mechanical stress on the joint. BFR training can be applied using continuous or intermittent protocols. Continuous BFR maintains cuff pressure throughout both exercise and rest periods, whereas intermittent BFR involves periodic deflation during rest intervals. These variations may influence physiological responses, fatigue levels, perceived exertion, and overall exercise tolerance, which are critical factors in clinical rehabilitation.This randomized controlled trial is designed to compare the effects of intermittent and continuous BFR training on pain, functional ability, muscle strength, and exercise perception in females with Grade II knee osteoarthritis. A total of 84 participants will be randomly allocated into two intervention groups and will undergo structured low-load resistance training in conjunction with standard physiotherapy care over a period of 8-12 weeks.Outcome measures will be assessed at baseline, 4 weeks, 8 weeks, and 12 weeks, including pain intensity (Numeric Pain Rating Scale), functional status (WOMAC Index), quadriceps muscle strength, and perceived exertion (Modified Borg Scale). The findings of this study are expected to provide evidence-based insights into the comparative effectiveness and tolerability of BFR application methods, thereby supporting optimized rehabilitation strategies and improving patient-centered outcomes in knee osteoarthritis management.

Tipo de estudio

Intervencionista

Inscripción (Actual)

84

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Punjab Province
      • Lahore, Punjab Province, Pakistán, 05450
        • Social Security Hospital, Lahore

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Female patients aged 40-49 years.
  • Diagnosed with Grade II knee osteoarthritis (radiographically confirmed).
  • Moderate to severe pain (NPRS 4-7).
  • Ability to participate in exercise programs.

Exclusion Criteria:

  • Severe cardiovascular disease.
  • Uncontrolled hypertension.
  • Recent knee surgery or intra-articular injection.
  • Active cancer or metastatic disease

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intermittent blood flow
Participants will perform low-load resistance exercises at 20-30% of one-repetition maximum (1RM) combined with intermittent BFR application. Cuff pressure will be applied during exercise sets and released during rest intervals. Each session will include a 10-minute warm-up , followed by a 30-minute structured exercise program and a 15-minute cool-down. Sessions will be conducted 2-3 times per week for a duration of 8-12 weeks, with progressive overload applied as tolerated.
Hamstrings stretching, 3 repetitions of 30 s, Bridge with isometric contraction of the transversus abdominis-CORE training, 3 repetitions of 30 s, Hip abduction with weights , 3 sets of 10 repetitions, Calm exercises with an elastic band, 3 sets of 10 repetitions, Calf raises with weights , 3 sets of 10 repetitions, Sensori-motor training at mini-trampoline, 3 repetitions of 30 s, Leg press, 0-60°, 4 sets of 10 repetitions, Seated knee extension , 90-0° of knee flexion, 4 sets of 10 repetitions. In the iBFR group, the cuff is deflated during each set's rest period and is quickly reinflated to the target pressure 20-30 s into the rest, ensuring the entire rest period does not exceed 45 s . Intensity: 20- 30% of 1RM with BFR cuffs, Frequency: 3 sessions per week for 12 weeks. Each session comprises a 10-min warm up with static cycling, a 30-min exercise program, and a 15-min cool down. BFR cuff from Hhccteo company will be used. pressure:130-150 mmHg, cuff width 5-7cm
Experimental: Continuous blood flow training
Participants will perform the same low-load resistance exercise protocol (20-30% 1RM) with continuous BFR application. Cuff pressure will be maintained throughout both exercise and rest periods. Exercise selection, session structure (warm-up, training, cool-down), frequency (2-3 sessions/week), and duration (8-12 weeks) will be identical to Group A to ensure comparability between groups
Hamstrings stretching, 3 repetitions of 30 s, Bridge with isometric contraction of the transversus abdominis-CORE training, 3 repetitions of 30 s, Hip abduction with weights (side lying), 3 sets of 10 repetitions, Calm exercises (side lying) with an elastic band, 3 sets of 10 repetitions, Calf raises with weights (standing), 3 sets of 10 repetitions, Sensori motor training (standing) at mini-trampoline, 3 repetitions of 30 s, Leg press (machine), 0-60°, 4 sets of 10 repetitions, Seated knee extension, 90-0° of knee flexion, 4 sets of 10 repetitions. In the cBFR group, the Intensity of excersise will be 20-30% of 1RM with BFR cuffs ,Frequency: 3 sessions per week for 12 weeks. Each session comprises a 10-min warmup with static cycling, a 30-min exercise program, and a 15-min cool down. BFR cuff from Hhccteo company will be used. The parameters will be pressure: 130-150 mmHg, cuff width 5-7 cm. Progressive overload will be applied by gradually increasing repetitions or load as tolerated

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Manual Muscle Testing (MMT)
Periodo de tiempo: baseline, 6 weeks (post intervention), 12 weeks (follow up)
Quadriceps strength will be assessed using standardized isometric testing procedure. It grades muscle strength on a 0-5 scale based on the ability to move a joint against gravity and external resistance. A grade of 0 indicates no visible or palpable muscle contraction, while 1 (Trace) represents a slight contraction without actual movement. Grade 2 (Poor) describes the ability to move the joint through its full range only when gravity is eliminated, whereas Grade 3 (Fair) allows movement through the full range against gravity but without resistance. Grade 4 (Good) indicates movement against moderate resistance, and Grade 5 (Normal) reflects full range of motion against maximal resistance, representing normal muscle strength
baseline, 6 weeks (post intervention), 12 weeks (follow up)
Numeric Pain Rating Scale (NPRS)
Periodo de tiempo: baseline, 6 weeks (post intervention), 12 weeks( followup)
The NPRS is a10-point scale (0-10) used to quantify pain intensity. Pain severity will be interpreted as no pain (0), mild pain (1-3), moderate pain (4-6), and severe pain (7-10).
baseline, 6 weeks (post intervention), 12 weeks( followup)
Modified Borg Scale
Periodo de tiempo: baseline, 6 weeks( post intervention), 12 weeks (follow up)
It is used to assess ratings of exercise-related perceived exertion. The scale ranges from (0 to 10), where 0 means no breathlessness at all and 10 means maximium breathlessness. According to this, 0-2 for Minimal exertion, 3-4 for Moderate (often target for rehab), 5-6 for Hard and 7-10 is for Very hard to maximal
baseline, 6 weeks( post intervention), 12 weeks (follow up)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de mayo de 2026

Finalización primaria (Actual)

10 de julio de 2026

Finalización del estudio (Actual)

20 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

20 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

20 de julio de 2026

Publicado por primera vez (Actual)

23 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • UBAS/ERB/26/04/012

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .