Effects of a Multicomponent Training Program on Health Outcomes in Patients with Abdominal Wall Hernia

NCT ID: NCT06872554

Last Updated: 2025-03-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-12-15

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.

Conditions

Abdominal Wall Hernia; Prevention; Exercise; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Supervised Exercise Intervention

Group that will follow the 12-week training program supervised by a professional in physical activity and sports sciences.

Group Type: EXPERIMENTAL

Supervised exercise training

Intervention Type: OTHER

The intervention will consist of a 12-week multicomponent training program. This program will include exercises focused on strength training, mobility, stretching, and breathing. Throughout the 12 weeks, there will be a progressive increase in training volume-understood as the number of sets and repetitions performed-and in intensity, defined as the difficulty involved in performing the exercises. After each training session, data will be collected on the perceived effort and the pain in the area affected by the abdominal hernia.

Non Supervised Exercise Intervention

Group that will follow the 12-week training program from home, without the supervision of a professional in physical activity and sports sciences.

Group Type: ACTIVE_COMPARATOR

Non supervised exercise training

Intervention Type: OTHER

The intervention will consist of a 12-week multicomponent training program. This program will include exercises focused on strength training, mobility, stretching, and breathing. Throughout the 12 weeks, there will be a progressive increase in training volume-understood as the number of sets and repetitions performed-and in intensity, defined as the difficulty involved in performing the exercises. After each training session, data will be collected on the perceived effort and the pain in the area affected by the abdominal hernia. This program will be realized for the participants at home, with the use of a specified training App, without the supervision of a sport science professional.

Control Group

Participants randomly assigned to the control group will receive advice on the importance of an active lifestyle for their quality of life.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supervised exercise training

The intervention will consist of a 12-week multicomponent training program. This program will include exercises focused on strength training, mobility, stretching, and breathing. Throughout the 12 weeks, there will be a progressive increase in training volume-understood as the number of sets and repetitions performed-and in intensity, defined as the difficulty involved in performing the exercises. After each training session, data will be collected on the perceived effort and the pain in the area affected by the abdominal hernia.

Intervention Type: OTHER

Non supervised exercise training

The intervention will consist of a 12-week multicomponent training program. This program will include exercises focused on strength training, mobility, stretching, and breathing. Throughout the 12 weeks, there will be a progressive increase in training volume-understood as the number of sets and repetitions performed-and in intensity, defined as the difficulty involved in performing the exercises. After each training session, data will be collected on the perceived effort and the pain in the area affected by the abdominal hernia. This program will be realized for the participants at home, with the use of a specified training App, without the supervision of a sport science professional.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Virgen del Rocio, Sevilla

UNKNOWN

Sponsor Role: collaborator

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Borja Sañudo

Head of the Department of Physical Education and Sport

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Borja Sañudo Corrales, Phd

Role: STUDY_DIRECTOR

University of Seville

Central Contacts

Jose Luis Gil Delgado, Phd

Role: CONTACT

luisdlgd3@gmail.com

+34654143004

Other Identifiers

PID2022-142316OB-I02

Identifier Type: -

Identifier Source: org_study_id