Clinical trial NCT06872554: Effects of a Multicomponent Training Program on Health Outcomes in Patients with Abdominal Wall Hernia
Official title: Effects of a Pre Surgery Multicomponent Training Program on Strength, Pain, and Quality of Life in Patients with Abdominal Wall Hernias
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Wall Hernia
Prevention
Exercise
Physical Activity
Keywords: hernia
abdominal wall
exercise intervention
quality of life
pain
incisional hernial
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: University Hospital Virgen del Rocio, Sevilla
First posted: 2025-03-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The following study is a randomized clinical trial consisting of three parallel arms. Stratified randomization will be performed to allocate subjects into the three groups (supervised intervention, unsupervised intervention, and control group). Subjects with 12 weeks or less until surgery will be randomized between the supervised intervention group and the control group. Subjects with more than 12 weeks until surgery will be included in the unsupervised intervention group.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

In conclusion, this study proposes that a multicomponent prehabilitation program could not only improve functional capacity and reduce preoperative pain in patients with abdominal wall hernias but also optimize postoperative outcomes and overall recovery. This approach is based on accumulated evidence in other clinical and surgical fields, reinforcing the need to explore its applicability and effectiveness in this specific context.

Study Objectives:

Evaluate the effects of a multicomponent training program on strength levels, quality of life, and pain in patients with abdominal wall hernias.

Assess the effects of the multicomponent training program on the aforementioned variables post-abdominal wall surgery.

Determine how the intervention affects hospital stay duration and postoperative complications.

Analyze differences between supervised and unsupervised training programs.

Compare postoperative functional recovery between the intervention and control groups.

Methodology:

An experimental, prospective, and longitudinal study will be conducted, implementing a multicomponent training program over 12 weeks. Patients will be recruited from the Abdominal Wall Surgery Unit of Virgen del Rocío Hospital.

Inclusión Criteria:

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

Exclusión Criteria:

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

Study Phases:

1. Patient Recruitment: Eligible patients will be randomized into three groups: supervised intervention, online intervention, and control.
2. Data Collection: Muscle strength, pain, quality of life, perceived exertion, and body composition will be evaluated pre-intervention, post-intervention, and three months post-surgery.
3. Statistical Analysis: Descriptive and multivariate statistical models will be applied to determine associations between intervention and study variables.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Abdominal Muscles Wall Strength
timeFrame: Pre (0 week), Post (12 week), Post Surgery (3 month)
measure: Health Releated Quality of Life
timeFrame: Pre (0 week), Post (12 week), Post Surgery (1 month), Post Surgery (3 month)
measure: Pain
timeFrame: Pre (0 week), Post (12 week), Post Surgery (1 month), Post Surgery (3 month)
Secondary outcomes:
measure: Physical Activity Level
timeFrame: Pre (0 week)
measure: Sedentary Behaviour
timeFrame: Pre (0 week)
measure: Physical Performance
timeFrame: Pre (0 week), Post (12 week), Post Surgery (3 month)
measure: Body Composition
timeFrame: Pre (0 week), Post (12 week), Post Surgery (3 month)
Other outcomes:
Locations:
Study officials:
affiliation: University of Seville
name: Borja Sañudo Corrales, Phd
role: STUDY_DIRECTOR
References: