Abdominal Wall HerniaNCT06872554
Effects of a Multicomponent Training Program on Health Outcomes in Patients with Abdominal Wall Hernia
A study testing Supervised exercise training and Non supervised exercise training in people with Abdominal Wall Hernia and Prevention, run by University of Seville.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wall Hernia, Prevention, Exercise
- What is being tested?
- Supervised exercise training and Non supervised exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years
- Ventral hernia ≥ 4cm (W2-3 per EHS classification)
- Signed informed consent
Who cannot join
- Patients <18 years
- Ventral hernia <4cm (W1 per EHS classification)
- Severe physical/cognitive impairment affecting mobility and daily activities
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of a Pre Surgery Multicomponent Training Program on Strength, Pain, and Quality of Life in Patients with Abdominal Wall Hernias
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.
Read the 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:
- Patient Recruitment: Eligible patients will be randomized into three groups: supervised intervention, online intervention, and control.
- 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.
- 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
- Being tested
- Supervised exercise training, Non supervised exercise training
- Keywords
- hernia, abdominal wall, exercise intervention, quality of life, pain, incisional hernial
- Medical subject headings
- Hernia, Abdominal, Motor Activity, Hernia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise trainingOther
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 trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Intervention | Experimental | Group that will follow the 12-week training program supervised by a professional in physical activity and sports sciences. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: Pre (0 week), Post (12 week), Post Surgery (1 month), Post Surgery (3 month)
Secondary outcomes (4)
Physical Activity Level
The level of physical activity will be assessed using the IPAQ Short Version questionnaire, which assess the physical activity on the las 7 days.
Measured: Pre (0 week)
Sedentary Behaviour
The level of sedentary behavior will be assessed using the Sedentary Behavior Questionnaire (SBQ), which evaluates the time a person spends sitting on weekdays and weekends.
Measured: Pre (0 week)
Physical Performance
To assess physical abilities, three tests from the Senior Fitness Test will be used: handgrip strength, sit-to-stand in 30 seconds, and walking speed over 4 meters.
Measured: Pre (0 week), Post (12 week), Post Surgery (3 month)
Body Composition
Muscle mass, fat mass, weight, and body mass index (BMI) will be evaluated using a digital bioimpedance scale (TANITA BC 545N).
Measured: Pre (0 week), Post (12 week), Post Surgery (3 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Responsible party
- Principal investigator, Borja Sañudo, University of Seville
- Investigators
- Borja Sañudo Corrales, Phd, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872554
- Sponsor's protocol ID
- PID2022-142316OB-I02
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Once processing, quality control, analysis and publication are complete, the data will be made accessible in open access repositories. These data will be anonymized (remove potentially identifying information).
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Pre Surgery Multicomponent Training Program on Strength, Pain, and Quality of Life in Patients with Abdominal Wall Hernias
- ClinicalTrials.gov ID
- NCT06872554
- Acronym / sponsor ID
- PID2022-142316OB-I02
- Conditions
- Abdominal Wall Hernia, Prevention, Exercise, Physical Activity
- Keywords
- hernia, abdominal wall, exercise intervention, quality of life, pain, incisional hernial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Hospitales Universitarios Virgen del Rocío
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 12 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Patient Recruitment: Eligible patients will be randomized into three groups: supervised intervention, online intervention, and control.
- 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.
- Statistical Analysis: Descriptive and multivariate statistical models will be applied to determine associations between intervention and study variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Intervention | Experimental | Other: Supervised exercise trainingGroup that will follow the 12-week training program supervised by a professional in physical activity and sports sciences. |
| Non Supervised Exercise Intervention | Active comparator | Other: Non supervised exercise trainingGroup that will follow the 12-week training program from home, without the supervision of a professional in physical activity and sports sciences. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients ≥ 18 years
- Ventral hernia ≥ 4cm (W2-3 per EHS classification)
- Signed informed consent
Key exclusion criteria (3 listed)
- Patients <18 years
- Ventral hernia <4cm (W1 per EHS classification)
- Severe physical/cognitive impairment affecting mobility and daily activities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised exercise trainingThe 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. | Other | Supervised Exercise Intervention |
| Non supervised exercise trainingThe 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. | Other | Non Supervised Exercise Intervention |
Primary outcome
Abdominal Muscles Wall Strength
Time frame: 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
Time frame: 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
Time frame: 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.
4 secondary outcomes
Physical Activity Level
Time frame: Pre (0 week)
Sedentary Behaviour
Time frame: Pre (0 week)
Physical Performance
Time frame: Pre (0 week), Post (12 week), Post Surgery (3 month)
Body Composition
Time frame: Pre (0 week), Post (12 week), Post Surgery (3 month)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Individual participant dataSharing planned: Undecided. Once processing, quality control, analysis and publication are complete, the data will be made accessible in open access repositories. These data will be anonymized (remove potentially identifying information).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Borja Sañudo Corrales, Phd study director
University of Seville
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise training and Non supervised exercise training in people with Abdominal Wall Hernia and Prevention, run by University of Seville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jose Luis Gil Delgado, Phd (+34654143004, luisdlgd3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Muscles Wall Strength (time frame: Pre (0 week), Post (12 week), Post Surgery (3 month)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.