NCT06988917

Brief Summary

The purpose of this study is to understand the effect of low-load blood flow restriction training on the rehabilitation effect of patients after lateral patellar compression syndrome surgery, and to observe the differences between low-load blood flow restriction training combined with conventional rehabilitation training and conventional rehabilitation training. The main question it aims to answer is: Can low-load blood flow restriction training improve the rehabilitation effect of patients after surgery for lateral patellar hypertension syndrome? Researchers compared conventional rehabilitation training with conventional rehabilitation training combined with low-load blood-limiting training to explore the effect of blood-limiting training combined with conventional rehabilitation training on the lower extremity function of patients after lateral patellar compression syndrome surgery, providing experimental and theoretical basis for formulating rehabilitation training programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 2, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 25, 2025

Completed
Last Updated

May 25, 2025

Status Verified

March 1, 2024

Enrollment Period

5 months

First QC Date

April 29, 2025

Last Update Submit

May 22, 2025

Conditions

Keywords

Lateral Patellar Compression Syndromepatellofemoral jointLL-BFRT

Outcome Measures

Primary Outcomes (4)

  • Lysholm score

    0-4week

  • VAS score

    0-4week

  • Peak torque of knee extension

    0-4week

  • Quadriceps thickness

    0-4week

Secondary Outcomes (2)

  • Thigh circumference

    0-4week

  • Range of motion of the knee joint

    0-4week

Study Arms (2)

The experimental group (LL-BFRT group)

The experimental group (LL-BFRT group) received exercise intervention treatment for 4 weeks, training three times a week, each time lasting for 1 hour. Compared with the control group (conventional rehabilitation group), the movements and intensities of the two groups remained consistent during the exercise intervention. Only the experimental group wore a flow-limiting pressure band for exercise during the intervention. The blood flow limiting pressure band used in this study mainly consists of a 109\*10cm leg pressure band, a barometric display dial with a pressure range of 0-300mmHg, and a pressure pump. In the experiment, we fixed the blood flow restriction pressure band in the area for measuring the circumference and adjusted the blood flow restriction pressure according to the thigh circumference of the subjects to maintain it within the range of 40%-60% arterial occlusion pressure. The way to limit blood flow is intermittent inflation.

Behavioral: the regular rehabilitation programDevice: The blood flow limiting pressure band

The control group (conventional rehabilitation group)

The control group (conventional rehabilitation group) received exercise intervention treatment for 4 weeks, with training three times a week, each lasting for 1 hour. The specific intervention contents are: Each training session consists of a 10-minute warm-up (including power cycling, full-body stretching, etc.) At the same time, use the foam axis to relax the lateral oblique femoris and iliotibial band to relieve the pressure on the lateral side of the patella), 40 minutes of formal training (including wall squats with a ball, straight leg raising resistance training, terminal resistance knee extension training, bench kick ball clamping training, and balance training), and 10 minutes of relaxation (using a foam roller, foam axis and other combined techniques to relax the muscles Especially for the lower limb muscles such as the lateral femoris, iliotibial band, and tibialis anterior muscle.

Behavioral: the regular rehabilitation program

Interventions

Each training session consists of a 10-minute warm-up (including power cycling, full-body stretching, etc.) At the same time, use the foam axis to relax the lateral oblique femoris and iliotibial band to relieve the pressure on the lateral side of the patella), 40 minutes of formal training (including wall squats with a ball, straight leg raising resistance training, terminal resistance knee extension training, bench kick ball clamping training, and balance training), and 10 minutes of relaxation (using a foam roller, foam axis and other combined techniques to relax the muscles Especially for the lower limb muscles such as the lateral femoris, iliotibial band, and tibialis anterior muscle.

The control group (conventional rehabilitation group)The experimental group (LL-BFRT group)

The experimental group (LL-BFRT group) wore a flow-limiting pressure band for exercise during routine rehabilitation training. The blood flow limiting pressure band used in this study mainly consists of a 109\*10cm leg pressure band, a barometric display dial with a pressure range of 0-300mmHg, and a pressure pump. In the experiment, we fixed the blood flow restriction pressure band in the area for measuring the circumference and adjusted the blood flow restriction pressure according to the thigh circumference of the subjects to maintain it within the range of 40%-60% arterial occlusion pressure. The way to limit blood flow is intermittent inflation, that is, during the intervals of muscle strength training, the cuff deflation operation is carried out simultaneously.

The experimental group (LL-BFRT group)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patient with lateral patellar compression syndrome after lateral retinacular release

You may qualify if:

  • Aged 30-60 years with a Visual Analog Scale (VAS) score ≥3;
  • Diagnosed with lateral patellar compression syndrome confirmed by MRI and clinical evaluation, having undergone arthroscopic lateral retinacular release surgery;
  • Presenting postoperative reduction in thigh circumference on the affected side, accompanied by quadriceps muscle atrophy and decreased muscle strength;
  • Minimum postoperative duration of ≥2 weeks, with signed informed consent and demonstrated ability to comply with the study protocol.

You may not qualify if:

  • Patients with concomitant fractures or other ligament injuries (including those with prior ACL reconstruction);
  • Individuals presenting with severe osteoarthritis or rheumatoid arthritis;
  • Those with medical histories of deep vein thrombosis, coagulation disorders, vascular diseases, or diabetes mellitus;
  • Subjects with active infections, malignancies, current pregnancy, or psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital of Chongli

Chongli, Hebei, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Age, Body Mass Index (BMI), Gender, Site of Injury, and Combined Meniscal Injury

Study Officials

  • Yuping Yang

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2025

First Posted

May 25, 2025

Study Start

March 2, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

May 25, 2025

Record last verified: 2024-03

Locations