Clinical trial NCT05484141: The Effect of Blood Flow Restriction Method in Patellar Instability
Official title: The Effect of Blood Flow Restriction Applied to the Extensor Muscles on Muscle Architecture and Strength, Knee Pain, and Functions in Minor Patellar Instability
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patellar Abnormality
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The blood flow restriction method, the effects of which have been frequently investigated in the literature in recent years, can produce muscle hypertrophy with low-intensity load and can be easily tolerated through to low mechanical stress, seems to be an exercise approach that can be used in the recovery of strength in cases with minor patellar instability and can contribute to the recovery of functional capacity without delay.

Detailed description: Patellar instability is defined as disruption of normal movement of the patella in the trochlear groove, symptomatic, medial-lateral displacement. Patients with patellar instability may not be able to tolerate high-intensity quadriceps exercises in the early period of strengthening programs due to pain symptoms, and therefore strength recovery may be delayed. However, it is important to restore muscle strength, especially vastus medialis obliquus strength, as early as possible in patellar instability. The blood flow restriction method, the effects of which have been frequently investigated in the literature in recent years, can produce muscle hypertrophy with low-intensity load and can be easily tolerated through to low mechanical stress, seems to be an exercise approach that can be used in the recovery of strength in cases with minor patellar instability and can contribute to the recovery of functional capacity without delay.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-40 years,
* Volunteering to participate in the study,
* Having a complaint of anterior knee pain for at least 3 months,
* Having been diagnosed with unilateral minor patellar instability,
* Absence of any other ongoing clinical problems that interfere with exercise (will be questioned by the Physical Activity Readiness Questionnaire for All).

Exclusion Criteria:

* History of one or more traumatic-atraumatic patella dislocations,
* Evidence of osteoarthritis on radiological imaging (≥ Kellgren-Lawrence Stage 2)
* Having at least one of the contraindications preventing the application of blood flow restrictive exercises (Smoking, previous venous thromboembolism, risk of peripheral vascular disease (ankle-brachial index \<0.9), coronary heart disease, hypertension, hemophilia, etc.),
* Previously diagnosed cardiovascular disease limiting effort capacity (Myocardial infarction, angina, exercise intolerance, etc.),
* Previously diagnosed neurological disorder or cognitive dysfunction (stroke, dementia, schizophrenia, etc.),
* Orthopedic lower extremity surgery in the last 1 year,
* Body mass index ≥ 30 kg/m2.

Primary outcomes:
measure: Assessment of Muscle Architecture and Hypertrophy
timeFrame: 8 weeks
Secondary outcomes:
measure: Assessment of Muscle Strength
timeFrame: 8 weeks
measure: Assessment of Pain
timeFrame: 8 weeks
measure: Evaluation of Functions
timeFrame: 8 weeks
measure: Evaluation of Satisfaction and Change
timeFrame: 8th week
Other outcomes:
Locations:
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Ayşe Zengin Alpözgen, PhD
role: STUDY_DIRECTOR
References: