跳至主要内容
临床试验/NCT07361848
NCT07361848尚未招募不适用

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

Universidad Complutense de Madrid1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2027年2月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Functional Disability (Victorian Institute of Sport Assessment Scale for Tendinopathy, VISA-P Score)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Only the outcomes assessors are masked to group allocation. Ultrasound technicians, elastography operators, and biomechanical evaluators remain blinded throughout all assessment time points (T0, T1, T2, T3). Due to the nature of the exercise-based intervention, neither participants nor care providers can be blinded. Investigators responsible for data analysis will work with anonymized, coded datasets to maintain allocation concealment during statistical procedures.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.
  • Inability to commit to follow-up assessments at 8, 12, and 24 weeks.

研究组 & 干预措施

Long-Hold Yielding Isometrics

Experimental

This arm receives a structured long-hold yielding isometric (LH-YI) exercise program targeting the patellar tendon. Participants perform 3-5 sets of 3-5 repetitions, each consisting of a 30-60 second sustained isometric contraction at a discomfort level of 3-4/10. Exercises are performed three times per week for 8 weeks, using a yielding squat or mid-range knee-flexion isometric position. Load is individualized based on tolerance. One supervised session per week ensures correct technique and monitoring. The protocol aims to improve pain, tendon vascularity, stiffness, and neuromechanical performance through prolonged tendon loading.

干预措施: Long-Hold Yielding Isometric Exercise Program (Behavioral)

Usual-Care Training Condition

Active Comparator

This arm follows standard training recommendations for patellar tendinopathy without exposure to long-duration isometric loading. Participants maintain their regular weightlifting training with guidance on load management, symptom monitoring, and progressive strengthening. No sustained isometric exercises are permitted. This condition serves as a real-world comparable control to evaluate the specific effects of long-hold yielding isometrics on pain, function, tendon vascularity, stiffness, and neuromechanical performance.

干预措施: Usual-Care Training Condition (Other)

结局指标

主要结局

Functional Disability (Victorian Institute of Sport Assessment Scale for Tendinopathy, VISA-P Score)

时间窗: Baseline, 8 weeks (post-intervention), 12 weeks follow-up, 24 weeks follow up

Patellar tendon-related functional impairment assessed using the Victorian Institute of Sport Assessment for Patellar Tendinopathy (VISA-P) questionnaire (0-100). Higher scores indicate better function. This measure evaluates global clinical improvement and load tolerance in daily living and sports context.

Pain During Tendon-Loading Activities (Numeric Pain Rating Scale)

时间窗: Baseline, 8 weeks (post-intervention), 12 weeks follow-up, and 24 weeks follow-up

Pain intensity during tendon-loading activities, such as squatting or jumping, assessed using the Numeric Pain Rating Scale (NPRS, 0-10), where 0 represents no pain and 10 represents the worst pain imaginable. Higher scores indicate greater pain. This outcome reflects symptom severity and clinical response to the intervention.

Patellar Tendon Vascularity (Surface Area Quantification)

时间窗: Baseline and 8 weeks (post-intervention)

Quantitative assessment of intratendinous vascularity using Surface Area Quantification (SAQ) derived from power Doppler ultrasound images. Doppler images are processed using image segmentation in Fiji/ImageJ software to isolate Doppler-positive pixels within a predefined tendon region of interest. Vascularity is expressed as the percentage of Doppler-positive pixel area relative to the total tendon area analyzed, with higher percentages indicating greater intratendinous vascularization.

Patellar Tendon Vascularity (Öhberg Score)

时间窗: Baseline and 8 weeks (post-intervention)

Intratendinous neovascularization assessed using the Öhberg grading scale based on power Doppler ultrasound imaging. The scale ranges from 0 to 4, where 0 indicates absence of Doppler-detected vessels and higher scores indicate increasing degrees of intratendinous neovascularization. Higher scores represent greater vascularity.

Patellar Tendon Vascularity (Modified Öhberg Score)

时间窗: Baseline and 8 weeks (post-intervention)

Intratendinous neovascularization assessed using the Modified Öhberg grading scale based on power Doppler ultrasound imaging. The scale ranges from 0 to 5, reflecting the proportion and extent of Doppler-detected intratendinous vessels within the region of interest, with higher scores indicating greater vascularity.

Tendon echostructure: Patellar Tendon Cross-Sectional Area (CSA)

时间窗: Baseline, 8 weeks (post-intervention)

Patellar tendon cross-sectional area (CSA, square millimeters \[mm²\]) will be assessed using transverse B-mode ultrasound imaging. CSA will be measured at three standardized locations along the tendon (proximal, mid-portion, and distal), and the mean value across the three regions will be calculated and used for analysis. CSA reflects tendon morphology and structural adaptation to mechanical loading.

Tendon echostructure: Patellar Tendon Thickness

时间窗: Baseline, 8 weeks (post-intervention)

Patellar tendon thickness (millimeters \[mm\]) will be measured using longitudinal B-mode ultrasound imaging at three standardized locations along the tendon (proximal, mid-portion, and distal). The mean thickness across the three regions will be calculated and used for analysis. Tendon thickness represents a structural characteristic associated with tendon adaptation and pathological changes.

次要结局

  • Tendon Stiffness (Shear-Wave Elastography in kPa)(Baseline, 8 weeks (post-intervention))
  • Tendon Stiffness (Shear-Wave Velocity)(Baseline and 8 weeks (post-intervention))
  • Tendon Mechanical Properties: Stiffness (iPulley and Ultrasound)(Baseline, 8 weeks (post-intervention))
  • Maximal Isometric Force (IMTP or iPulley)(Baseline, 8 weeks (post-intervention))
  • Tendon Echointensity (B-mode Ultrasound, Echotexture)(Baseline, 8 weeks (post-intervention))
  • Tendon Echovariation (B-mode Ultrasound, Echotexture)(Baseline and 8 weeks (post-intervention))
  • Plyometric Performance Metrics: Reactive Strength Index (Force Plate Assessment)(Baseline and 8 weeks (post-intervention))
  • Plyometric Performance Metrics: Jump Height (Force Plate Assessment)(Baseline, 8 weeks (post-intervention))
  • Plyometric Performance Metrics: Ground Contact Time (Force Plate Assessment)(Baseline and 8 weeks (post-intervention))
  • Plyometric Performance Metrics: Flight time (Force Plate Assessment)(Baseline and 8 weeks (post-intervention))
  • Tendon Mechanical Properties: Strain (iPulley and Ultrasound)(Baseline, 8 weeks (post-intervention))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Almazán Polo

Assistant Professor of Physiotherapy and Principal Investigator

Universidad Complutense de Madrid

研究点 (1)

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