跳至主要内容
临床试验/NCT03985254
NCT03985254Unknown不适用

Does Adding Power Exercises to Muscle Force Training Result in Superior Benefits for Patellofemoral Pain People? Randomized and Controlled Clinical Trial

Universidade Federal de Sao Carlos2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2019年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
74
试验地点
2
主要终点
Change from baseline pain Intensity at 12 weeks

研究概览

简要总结

Patellofemoral pain (PFP) is one of the most common forms of knee pain and has a negative impact on the level of physical activity and quality of life of patients. Although strengthening of the hip and knee muscles has good clinical effects in the treatment of PFP, most exercise protocols do not follow the American College of Sports Medicine (ACSM) guidelines and are not clearly described, making it difficult to apply them in practice clinical and research. In addition, recent studies have shown that these patients also have a power deficit of these muscles. However, it is not known whether the addition of power exercises to a muscle strengthening program would result in superior benefits, especially in relation to pain and physical function. Therefore, the objective of this study is to verify if the improvement in pain intensity, physical function, kinesiophobia, self perception of improvement, quality of life and muscle function variables after a training program of strength and muscular power is superior to that observed in an isolated muscle strength training. This study will be randomized and controlled, developed with individuals with DPF, allocated in one of two groups: Strength Training Group (STG) and Strength and Power Training Group (SPTG). The primary outcomes will be intensity of pain and physical function, while the secondary outcomes will be kinesiophobia; self perception of improvement; quality of life; the peak of isometric abductor and hip extensor torque, and knee extensor; and the rate of development of torque of the abductors and extensors of hip, and extensors of knee at 30% and 90% of maximum isometric torque. Participants in both groups will be evaluated before the intervention (pre), after the end of the intervention (post) and three, six and twelve months after the intervention. Data analysis will follow the intention-to-treat principle. To compare the groups at different times (pre, post and after three, six and twelve months of the intervention) will be used two-way analysis of variance (GROUP X MOMENT) with mixed model, with Bonferroni post hoc to identify specific differences. The significance level will be 0.05.

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 (Investigator)

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

  • men and women with bilateral or unilateral patellofemoral pain

排除标准

  • history of knee surgery
  • history of hip or lumbar spine injury or pain
  • patellar instability
  • pain on palpation of the patellar tendon, iliotibial band, Hoffa fat, goose paw tendons or knee joint line
  • signs or symptoms of meniscal or knee ligament injuries
  • presence of Osgood-Schlatter syndrome or Sinding-Larsen-Johansson syndrome
  • any vestibular, neurological or musculoskeletal alterations that interfere or contraindicate the procedures of this study

研究组 & 干预措施

Strength Training Group (STG)

Active Comparator

The strength training program will consist of applying resistance and progressive exercises for strength gain and will be based on the training principles recommended by the American College of Sport Medicine. The exercises were chosen based on a pilot study that successfully applied the protocol to 10 participants with FPD (data to be published) and other strength training studies (MASCALL et al, 2003; DISTEFANO et al, 2009; REIMAN et al, 2012; BALDON et al, 2014; SILVA et al, 2015).

Initially, the goal will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]), and in subsequent weeks the goal will be the development of muscle strength (load> 70% 1RM). In addition, the protocol will initially focus on strengthening the hip and trunk muscles and after four weeks of training, exercises for the knee muscles will be included.

干预措施: Strength Training Group (STG) (Other)

Strength and Power Training Group (SPTG)

Experimental

Participants who are allocated to this group will perform the same exercise program performed by the STG, but with the addition of exercises that emphasize power gain. As in the other group, initially, the objective will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]). However, in subsequent weeks the goal will be to develop strength (load> 70% 1RM) and muscle power (load between 40-60% 1RM).

干预措施: Strength and Power Training Group (SPTG) (Other)

结局指标

主要结局

Change from baseline pain Intensity at 12 weeks

时间窗: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)

Pain intensity will be assessed using a 100-mm Visual Analog Scale (VAS), with 0 indicating no pain and 10 indicating extremely intense pain. Participants will indicate their usual pain and their worst pain during the last week (CROSSLEY et al, 2004). The VAS scores will be computed by measuring the length of the line, in millimeters, from the left end (without pain) until the mark made by the participant.

Change from baseline physical function at 12 weeks

时间窗: Pre (baseline) treatment, post treatment (12 weeks) and after 3,6 and 12 month (follow-up)

The Anterior Knee Pain Scale, a translated and validated Portuguese version (DA CUNHA et al, 2013), will be used to evaluate subjective symptoms, such as anterior knee pain and functional limitations related to PFP. The items assessed in the questionnaire are patellar subluxation, lameness, pain, walking, climbing stairs and remaining seated for prolonged time with knees flexed. It has scores of 0 to 100 points, where 100 means no pain and / or functional limitations and 0 means constant pain and several functional limitations (KUJALA et al, 1993). The Anterior Knee Pain Scale is a reliable and valid instrument to evaluate the function in individuals with PFP (CROSSLEY et al, 2004). The final score will be used for statistical analysis.

次要结局

  • Self-perception of improvement(Pre (baseline) treatment and post treatment (12 weeks))
  • Change Quality of Life(Pre (baseline) treatment and post treatment (12 weeks))
  • Maximal Isometric Torque and Rate of Force Development (RFD)(Pre (baseline) treatment and post treatment (12 weeks))
  • Kinesiophobia(Pre (baseline) treatment and post treatment (12 weeks))

研究者

发起方
Universidade Federal de Sao Carlos
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gabriela Souza de Vasconcelos

Post graduate

Universidade Federal de Sao Carlos

研究点 (2)

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