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Набор скоро начнётся NCT07361848

Long-Hold Yielding Isometric Exercise for Patellar Tendinopathy in Weightlifting Athletes

Без фазы С лечением Patellar Tendinopathy / Jumpers Knee

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Long-Hold Yielding Isometric Exercise Program, Usual-Care Training Condition.
Кому может быть актуально
Состояния в реестре: Patellar Tendinopathy / Jumpers Knee. Базовые параметры: 18 лет — 45 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Испания
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Randomized Controlled Trial Evaluating the Effects of Long-Hold Yielding Isometric Exercise on Pain, Function, Vascularity, and Mechanical Properties of the Patellar Tendon in Competitive Weightlifting Athletes

Обзор

The goal of this clinical trial is to evaluate whether a long-hold yielding isometric exercise program improves pain, tendon vascularity, mechanical properties, and functional performance in weightlifting athletes with patellar tendinopathy. The study will also explore the safety and feasibility of this exercise strategy. Researchers will compare the long-hold isometric intervention with routine training recommendations to determine its effects on symptoms and tendon function. Participants will perform the supervised isometric protocol and complete pain ratings, functional tests, and ultrasound evaluations of the patellar tendon.

Подробное описание

This randomized controlled trial is part of the QuantFlow research program, a multidisciplinary initiative designed to advance the understanding of patellar tendon pathology through the integration of quantitative ultrasound imaging, Doppler-based intratendinous vascularity assessment, shear-wave elastography, biomechanical performance testing, and clinical evaluation. Within this framework, the present trial evaluates the therapeutic, mechanobiological, and functional effects of a long-hold yielding isometric exercise protocol in competitive weightlifting athletes with vascularized patellar tendinopathy.

Patellar tendinopathy is a common overload-related condition in Olympic weightlifting due to the repetitive exposure to high mechanical loads during movements such as deep squats, cleans, jerks, and ballistic pulling actions. These demands can result in localized tendon pain, reduced load tolerance, and impaired athletic performance. Ultrasound imaging in symptomatic athletes frequently reveals increased tendon thickness, hypoechoic regions, altered fibrillar organization, and varying degrees of Doppler-detected intratendinous vascularity. Although the clinical relevance of vascularity remains debated, its presence may be associated with pain modulation and tissue remodeling. Understanding how targeted tendon-loading strategies influence vascularity, stiffness, structure, and symptoms is therefore central to this trial.

Long-hold yielding isometric loading is a specific exercise strategy characterized by sustained tendon loading for extended durations, typically lasting 30 to 60 seconds per repetition. Compared with short-duration isometric contractions, prolonged loading is thought to stimulate mechanotransductive pathways more effectively, potentially promoting collagen reorganization, modulation of tendon stiffness, and improvements in neuromuscular efficiency. Prolonged isometric loading may also induce short-term analgesic effects and influence intratendinous vascular responses. However, evidence supporting these mechanisms in high-performance weightlifting athletes is limited, and randomized controlled trials in this population are scarce.

The study follows a two-arm, parallel-group randomized controlled design with four assessment time points: baseline, post-intervention at 8 weeks, and follow-up assessments at 12 and 24 weeks. Participants are competitive weightlifting athletes aged 18 to 45 years who train at least three times per week and present with symptomatic patellar tendinopathy of at least six weeks' duration and a baseline VISA-P score below 80. Ultrasound confirmation of structural tendon changes or Doppler-detected vascularity is required. Key exclusion criteria include previous patellar tendon surgery, tendon rupture, recent injection therapies, systemic conditions affecting tendon health, significant concomitant knee pathology, pregnancy, or inability to comply with the study protocol.

Baseline assessments include pain evaluation during tendon-loading activities using the Numeric Pain Rating Scale, functional disability assessed with the VISA-P questionnaire, high-resolution B-mode ultrasound for tendon morphology, Doppler ultrasound for vascularity assessment, and shear-wave elastography for quantification of tendon stiffness. Neuromechanical performance is evaluated using force plate-based countermovement and reactive jump testing, providing measures such as jump height, force-time characteristics, impulse, and rate of force development. Maximal isometric force is assessed using standardized isometric testing procedures. All assessments follow standardized acquisition protocols to ensure reproducibility and inter-session reliability.

Participants are randomly allocated to either the intervention group or a usual-care control group using a computer-generated randomization schedule with allocation concealment. Outcome assessors for imaging and biomechanical testing are blinded to group assignment. The intervention group completes a long-hold yielding isometric exercise program consisting of three to five sets of three to five repetitions, each held for 30 to 60 seconds at a target discomfort level of 3 to 4 out of 10. Exercises are performed three times per week for eight weeks. The control group continues their usual training under standard tendinopathy management recommendations without exposure to long-duration isometric loading.

In addition to the primary and secondary outcome analyses, pre-specified exploratory subgroup analyses will be conducted stratified by biological sex (men and women) to examine whether sex modifies the response to the intervention. These analyses will be performed separately for key clinical, imaging, and biomechanical outcomes, including pain, functional status, tendon vascularity, tendon stiffness, and selected performance measures. The purpose of these analyses is exploratory and hypothesis-generating, and they are not intended to define additional independent outcome measures.

All primary and secondary outcome measures are reassessed at the post-intervention time point, with follow-up evaluations conducted at 12 and 24 weeks to determine the persistence of clinical, structural, and functional adaptations. Data quality is ensured through standardized operating procedures, routine quality-control checks, and secure data management practices. The study is conducted in accordance with international ethical standards for human research, including the principles of the Declaration of Helsinki and Good Clinical Practice.

Вмешательства

  • Поведенческое Long-Hold Yielding Isometric Exercise Program
    The intervention consists of a structured long-hold yielding isometric (LH-YI) loading program targeting the patellar tendon. Participants perform 3-5 sets of 3-5 repetitions, each held for 30-60 seconds at an intensity corresponding to 3-4/10 discomfort. Exercises are executed in a controlled knee-flexion position, either as a yielding squat or machine-assisted isometric hold. Training takes place three times per week for 8 weeks, with one supervised session weekly to ensure correct load, techn
  • Другое Usual-Care Training Condition
    Participants maintain their regular weightlifting training following standard recommendations for patellar tendinopathy management. This includes load monitoring, symptom-guided progression, avoidance of high-irritability movements, and general strengthening. No long-duration isometric exercises or targeted LH-YI loading are permitted. This condition serves as an active comparator reflecting real-world practice to isolate the specific therapeutic and mechanobiological effects of the long-hold yi

Первичные конечные точки

  • Functional Disability (Victorian Institute of Sport Assessment Scale for Tendinopathy, VISA-P Score) [Срок оценки: Baseline, 8 weeks (post-intervention), 12 weeks follow-up, 24 weeks follow up]
  • Pain During Tendon-Loading Activities (Numeric Pain Rating Scale) [Срок оценки: Baseline, 8 weeks (post-intervention), 12 weeks follow-up, and 24 weeks follow-up]
  • Patellar Tendon Vascularity (Surface Area Quantification) [Срок оценки: Baseline and 8 weeks (post-intervention)]
  • Patellar Tendon Vascularity (Öhberg Score) [Срок оценки: Baseline and 8 weeks (post-intervention)]
  • Patellar Tendon Vascularity (Modified Öhberg Score) [Срок оценки: Baseline and 8 weeks (post-intervention)]
  • Tendon echostructure: Patellar Tendon Cross-Sectional Area (CSA) [Срок оценки: Baseline, 8 weeks (post-intervention)]
  • Tendon echostructure: Patellar Tendon Thickness [Срок оценки: Baseline, 8 weeks (post-intervention)]
Вторичные конечные точки (11)
  • Tendon Stiffness (Shear-Wave Elastography in kPa) [Срок оценки: Baseline, 8 weeks (post-intervention)]
  • Tendon Stiffness (Shear-Wave Velocity) [Срок оценки: Baseline and 8 weeks (post-intervention)]
  • Tendon Mechanical Properties: Stiffness (iPulley and Ultrasound) [Срок оценки: Baseline, 8 weeks (post-intervention)]
  • Maximal Isometric Force (IMTP or iPulley) [Срок оценки: Baseline, 8 weeks (post-intervention)]
  • Tendon Echointensity (B-mode Ultrasound, Echotexture) [Срок оценки: Baseline, 8 weeks (post-intervention)]
  • Tendon Echovariation (B-mode Ultrasound, Echotexture) [Срок оценки: Baseline and 8 weeks (post-intervention)]
  • Plyometric Performance Metrics: Reactive Strength Index (Force Plate Assessment) [Срок оценки: Baseline and 8 weeks (post-intervention)]
  • Plyometric Performance Metrics: Jump Height (Force Plate Assessment) [Срок оценки: Baseline, 8 weeks (post-intervention)]
  • Plyometric Performance Metrics: Ground Contact Time (Force Plate Assessment) [Срок оценки: Baseline and 8 weeks (post-intervention)]
  • Plyometric Performance Metrics: Flight time (Force Plate Assessment) [Срок оценки: Baseline and 8 weeks (post-intervention)]
  • Tendon Mechanical Properties: Strain (iPulley and Ultrasound) [Срок оценки: Baseline, 8 weeks (post-intervention)]

Критерии участия

Критерии включения

  • Competitive weightlifting athletes (Olympic weightlifting or CrossFit) training ≥3 times per week.
  • Age 18-45 years.
  • Symptom duration of at least 6 weeks.
  • Presence of vascularized patellar tendinopathy, defined as Doppler-detectable intratendinous neovascularization using standardized settings.
  • VISA-P score < 80 at baseline.
  • Ability to perform loaded lower-limb exercises safely.
  • Willingness to refrain from other structured isometric interventions focused on the patellar tendon during the study period.
  • Ability to provide informed consent.
  • Sex/Gender requirement: both men and women eligible; the study includes sex-stratified analysis to examine potential sex-based differences in tendon response.

Критерии исключения

  • Previous knee surgery within the past 12 months.
  • Partial or complete patellar tendon rupture (confirmed clinically or by ultrasound).
  • Coexisting knee conditions (e.g., meniscal tear, ACL/PCL injury, patellofemoral joint instability) that significantly affect load tolerance.
  • Systemic diseases affecting tendon health (e.g., diabetes, rheumatoid arthritis, connective tissue disorders).
  • Corticosteroid injection in the patellar tendon within the last 6 months.
  • Participation in other clinical trials involving exercise or tendon-loading interventions.
  • Neuromuscular or medical conditions limiting safe performance of isometric or plyometric exercise.
  • Pregnancy.
  • Inability to commit to follow-up assessments at 8, 12, and 24 weeks.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Испания · 1 центр
  • Universidad Complutense de Madrid, Faculty of Nursing, Physiotherapy and Podiatry, Departm — Madrid

Публикации

  • Pringels L, Van Acker G, Wezenbeek E, Burssens A, Vanden Bossche L. Novel Insights Into the Intratendinous Pressure Behavior of the Achilles Tendon in Athletes. Sports Health. 2025 Mar;17(2):374-382. doi: 10.1177/19417381241245357. Epub 2024 Apr 12. PMID 38610105
  • Scattone Silva R, Song KE, Hullfish TJ, Sprague A, Silbernagel KG, Baxter JR. Patellar Tendon Load Progression during Rehabilitation Exercises: Implications for the Treatment of Patellar Tendon Injuries. Med Sci Sports Exerc. 2024 Mar 1;56(3):545-552. doi: 10.1249/MSS.0000000000003323. Epub 2023 Oct 16. PMID 37847102
  • Merkel, M. F. R., Hellsten, Y., Magnusson, S. P., and Kjaer, M. 2021. Tendon blood flow, angiogenesis, and tendinopathy pathogenesis. Transl Sports Med 4:756-771. https://doi.org/10.1002/TSM2.280.

Идентификаторы

NCT: NCT07361848 · UCM-JAP-QUANTFLOW-26

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗