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Completed

NCT Number: NCT07722975

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

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.

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Key information

Conditions

Knee Osteoarthristis

Age range

40 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Social Security Hospital, Lahore

Lahore, Punjab Province, 05450, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent blood flow training (iBFR)

Other

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

Continuous blood flow training (cBFR)

Other

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

Primary outcomes

  1. Manual Muscle Testing (MMT)

    Time frame: 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

  2. Numeric Pain Rating Scale (NPRS)

    Time frame: 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).

  3. Modified Borg Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Lahore University of Biological and Applied Sciences

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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