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临床试验/NCT06872554
NCT06872554尚未招募不适用

Effects of a Pre Surgery Multicomponent Training Program on Strength, Pain, and Quality of Life in Patients with Abdominal Wall Hernias

University of Seville0 个研究点目标入组 75 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
75
主要终点
Abdominal Muscles Wall Strength

研究概览

简要总结

Abdominal wall hernias are among the most prevalent pathologies today, characterized by specific symptoms such as pain, a sensation of tightness in the affected area, and potential gastrointestinal complications. These symptoms negatively impact patients' health and quality of life.

In other clinical conditions, such as osteoarthritis, sarcopenia, and fibromyalgia, participation in multicomponent training programs (which integrate strength, mobility, and stretching exercises) has been documented to significantly improve quality of life, reduce pain, and optimize patients' functional capacity. Likewise, scientific literature highlights that in the context of injuries requiring surgical intervention, such as anterior cruciate ligament or meniscus tears, patients who underwent prehabilitation programs based on multicomponent training experienced fewer losses in functional and structural aspects, such as strength and muscle mass. These programs also contributed to a reduction in postoperative pain perception.

Therefore, the primary objective of this study is to evaluate the effects of a multicomponent training program on health variables (pain, quality of life, perceived exertion, and recurrence) and functional capacity (trunk isometric strength, grip strength, and lower limb dynamic strength) in patients with abdominal wall hernias. As a secondary objective, the impact of this program on the aforementioned variables after abdominal wall repair surgery will be investigated.

详细描述

Background:

Abdominal wall hernias are one of the most prevalent pathologies in contemporary clinical practice, affecting a significant percentage of the global population. These hernias, characterized by the protrusion of organs or tissues through a weakened area in the abdominal musculature, may present symptoms such as pain, tightness, and gastrointestinal complications, impacting both general health and patients' quality of life. The management of these conditions often involves surgical intervention, with variable outcomes in terms of functional recovery and postoperative pain. However, there are still opportunities to improve preoperative and postoperative treatment strategies through comprehensive approaches that include adapted physical training programs.

In recent years, the field of physical rehabilitation has advanced significantly due to the development of multicomponent training programs. These programs, combining strength, mobility, and stretching exercises, have proven effective in improving quality of life and reducing pain in various chronic pathologies. For instance, in patients with osteoarthritis, multicomponent training has been shown not only to mitigate pain but also to improve functional capacity and reduce progressive joint deterioration. In sarcopenia, a common problem in older adults, resistance training has demonstrated significant benefits in maintaining muscle mass and strength, contributing to a better quality of life.

Moreover, participation in prehabilitation programs has been particularly beneficial in the context of surgical procedures. Recent studies have documented that patients undergoing anterior cruciate ligament or meniscal interventions who participated in multicomponent prehabilitation programs experienced less strength and muscle mass loss, as well as a reduced perception of postoperative pain. A recent meta-analysis also shows that prehabilitation programs including strength training and aerobic exercises contributed to improved functional outcomes and shorter hospital stays in patients undergoing major abdominal surgery. This proactive approach, which prepares the body for surgical stress, has proven to be an effective strategy for improving postoperative outcomes and accelerating recovery.

However, despite evidence supporting the use of multicomponent training programs in other clinical and surgical conditions, their application in patients with abdominal wall hernias has been scarcely explored. The current literature lacks studies that comprehensively address the impact of prehabilitation in this patient group, both in the preoperative phase and postoperative recovery. Given that hernia repair surgery is one of the most common surgical interventions, with significant implications for functional capacity and overall well-being, implementing prehabilitation strategies based on multicomponent training could represent an important innovation in managing these conditions.

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)

入排标准

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

入选标准

  • Patients ≥ 18 years
  • Ventral hernia ≥ 4cm (W2-3 per EHS classification)
  • Signed informed consent

排除标准

  • Patients <18 years
  • Ventral hernia <4cm (W1 per EHS classification)
  • Severe physical/cognitive impairment affecting mobility and daily activities

结局指标

主要结局

Abdominal Muscles Wall Strength

时间窗: Pre (0 week), Post (12 week), Post Surgery (3 month)

To assess the strength of the abdominal wall muscles, the isometric trunk flexion test in a seated position will be used, both in the sagittal and transverse planes, utilizing a strain gauge (Chronojump, Barcelona, Spain). The variables collected will be the maximum isometric strength and the rate of force development.

Health Releated Quality of Life

时间窗: Pre (0 week), Post (12 week), Post Surgery (1 month), Post Surgery (3 month)

Quality of life will be assessed using a specific questionnaire for abdominal wall hernias (HerQLes) and a general questionnaire (SF 12)

Pain

时间窗: Pre (0 week), Post (12 week), Post Surgery (1 month), Post Surgery (3 month)

Pain will be assessed using a visual analog scale (VAS), where 0 represents no pain and 10 represents maximum pain.

次要结局

  • Physical Activity Level(Pre (0 week))
  • Sedentary Behaviour(Pre (0 week))
  • Physical Performance(Pre (0 week), Post (12 week), Post Surgery (3 month))
  • Body Composition(Pre (0 week), Post (12 week), Post Surgery (3 month))

研究者

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

Borja Sañudo

Head of the Department of Physical Education and Sport

University of Seville

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