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NCT Number: NCT07384780

Isokinetic Exercise Combined With Blood Flow Restriction: High-Load Vs Low-Load Training

The goal of this clinical trial is to see which type of strengthening exercise with a tight band (blood flow restriction) helps people recover better after ACL reconstruction. The study includes adults after ACL surgery who are doing physiotherapy to rebuild thigh muscle strength and knee function.

The main questions are:

* Does heavy strengthening with blood flow restriction improve thigh strength, knee function, and daily activities more than light strengthening with blood flow restriction after ACL surgery? * Can light strengthening with blood flow restriction give similar benefits to heavy strengthening while putting less strain on the knee?

Researchers will compare a heavy-exercise program plus blood flow restriction to a light-exercise program plus blood flow restriction to see which gives better strength and functional improvements.

Participants will:

* Come for supervised physiotherapy sessions and do knee exercises on a machine, using either heavy or light loads while a cuff on the thigh gently squeezes to reduce blood flow. * Have their leg strength, and knee questionnaires checked several times during the study.

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This clinical trial is testing two different ways of doing strength training with a tight leg cuff (blood flow restriction) during rehabilitation after ACL reconstruction. The aim is to find out which program helps people rebuild thigh muscle strength and knee function more effectively, while still keeping the knee joint safe after surgery.

Study purpose and questions After ACL reconstruction, many people lose muscle size and strength in the front of the thigh, which can slow down recovery and delay return to sport or full activity. Blood flow restriction training allows people to train with lighter weights but still gain strength and muscle, which may be useful when heavy loads are not yet safe.

The main questions are:

  • Does a heavy-load isokinetic exercise program with blood flow restriction improve thigh strength, knee function, and patient-reported outcomes more than a low-load isokinetic program with blood flow restriction?
  • Can low-load isokinetic exercise with blood flow restriction provide similar benefits in strength and function, while placing less stress on the healing knee joint? Who will take part The study will include adults who have had ACL reconstruction and are in the strengthening phase of their rehabilitation. Participants will typically be active people, cleared by their surgeon and physiotherapist to start moderate to high resistance training, with no serious heart, blood vessel, or bleeding problems that would make blood flow restriction unsafe.

What happens in the study Participants will be randomly assigned to one of two groups so that each person has an equal chance of being in either group.

  • One group will do heavy-load isokinetic knee exercises with a blood flow restriction cuff on the thigh.
  • The other group will do low-load isokinetic knee exercises with the same type of cuff and similar exercise schedule.

Both groups will:

  • Attend supervised physiotherapy sessions several times per week for around 3-4 months.
  • Perform knee extension and flexion exercises on an isokinetic machine, where the speed of movement is controlled and resistance adjusts through the range of motion.
  • Wear a wide cuff around the upper thigh, which is inflated to a set pressure to partially reduce blood flow out of the leg during sets, then deflated during rest periods.

The physiotherapist will adjust the load (heavy or light), cuff pressure, and number of sets and repetitions according to a fixed protocol so that each participant trains safely and progressively over time.

Measurements and outcomes

Participants will be tested at the start of the study and at follow-up visits (for example, after several weeks and at the end of the program). The main outcome is peak quadriceps strength measured on an isokinetic dynamometer. Other outcomes may include:

  • Rate of torque development (how quickly the muscle can produce force).
  • Functional tests such as hop tests, walking or stair tests, and timed tasks.
  • Patient questionnaires about knee symptoms, daily activities, sports function, and quality of life.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

For ACLR group:

•Isolated unilateral ACL reconstruction 8-16 weeks post-surgery with medical clearance for moderate to high resistance training.

For control group(healthy population):

  • Healthy adults with no musculoskeletal pathology.

Exclusion criteria

  • History of cardiovascular or metabolic diseases
  • Deep vein thrombosis
  • Coagulopathy
  • Hypertension
  • Skin lesions or infections at the site of BFR cuff administration
  • Neuromuscular disorders
  • Non-clearance from the surgeon or physiotherapist or resistance training.

Treatment and study plan

High Load Isokinetic Training with Blood Flow Restriction

Other

High Load strength training that was administered through the use of an isokinetic device, and not conventional strength training equipment, combined with blood flow restriction.

Other names: High Load strength training, High Load Isokinetic training, Blood Flow Restriction, BFR

Low Load Isokinetic Training with Blood Flow Restriction

Other

Low Load strength training that was administered through the use of an isokinetic device, and not conventional strength training equipment, combined with blood flow restriction.

Other names: Low Load strength training, Low Load Isokinetic training, Blood Flow Restriction, BFR

Primary outcomes

  1. Muscle Strength

    Time frame: Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

    Muscle strength will be measured using Biodex System 4 Pro for concentric quadriceps and hamstring strength at 60°/s and eccentric quadriceps at 60°/s.

    Recorded parameters: peak torque(Nm/kg), total work(J), and average power(W).

  2. Muscle Girth

    Time frame: Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

    Muscle girth will be measured by measuring the mid-thigh circumference using an inch tape at 15cm above the superior border of the patella. The mean of two readings will be recorded

Secondary outcomes

  1. Pain Reduction

    Time frame: Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

    Pain will be evaluated using the Numeric Pain Rating Scale(0-10). This refers to the pain the patient experiences in their operated knee and will observe how it changes with administration of the intervention(s).

    Scale: 0-10 Minimum value: 0 Maximum value: 10 Higher is worse(more pain). Lower is better(less pain)

  2. Blood Flow

    Time frame: Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

    The blood flow to the affected knee will be assessed by using infrared thermography(IRT) using standardized imaging protocols(room temperature 20-24°C, 40-60% humidity).

  3. Tolerability and Perception of the Intervention(s)

    Time frame: Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)

    This will be recorded using a Likert-type questionnaire focusing on comfort, tightness, and willingness to repeat the intervention.

    Minimum value: 0 Maximum value: 10 Higher scores mean a better outcome. Lower scores mean a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Osman Z Khan, Bachelors of Physiotherapy

CONTACT

[email protected]

+971563292389

Sponsors and collaborators

Lead sponsor

Gulf Medical University

Other

Registry information

Official study title

Isokinetic Exercise Combined With Blood Flow Restriction: High-Load Vs Low-Load Training : A Randomized Controlled Trial in Post-ACL Reconstruction Populations

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Feb 5, 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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