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

NCT06872554 | Not Yet Recruiting

• 1 other identifier: PID2022-142316OB-I02
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Abdominal Wall Hernia; Prevention; Exercise; Physical Activity

Keywords

hernia; abdominal wall; exercise intervention; quality of life; pain; incisional hernial

Outcome Measures

Primary Outcomes (3)

• Abdominal Muscles Wall Strength

  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.

  Pre (0 week), Post (12 week), Post Surgery (3 month)

• Health Releated Quality of Life

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

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

• Pain

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

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

Secondary Outcomes (4)

• 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)

Study Arms (3)

Supervised Exercise Intervention

EXPERIMENTAL

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

Other: Supervised exercise training

Non Supervised Exercise Intervention

ACTIVE COMPARATOR

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

Other: Non supervised exercise training

Control Group

NO INTERVENTION

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

Interventions

Supervised exercise training 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.

Supervised Exercise Intervention

Non supervised exercise training 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.

Non Supervised Exercise Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Seville: lead
• University Hospital Virgen del Rocio, Sevilla: collaborator

MeSH Terms

Conditions

Hernia, Abdominal; Motor Activity; Hernia; Pain

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Borja Sañudo Corrales, Phd

  University of Seville

  STUDY DIRECTOR

Central Study Contacts

Jose Luis Gil Delgado, Phd

CONTACT

+34654143004; luisdlgd3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Physical Education and Sport

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: April 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: December 15, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03