Effects of a Multicomponent Training Program on Health Outcomes in Patients with Abdominal Wall Hernia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Seville
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years
Ventral hernia ≥ 4cm (W2-3 per EHS classification)
Signed informed consent
Disqualifiers
Patients <18 years
Ventral hernia <4cm (W1 per EHS classification)
Severe physical/cognitive impairment affecting mobility and daily activities
Trial design
Design model
Parallel
Treatments tested in this trial
Supervised exercise training
Other interventionThe 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 training
Other interventionThe 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.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Supervised Exercise InterventionExperimental treatment 1 intervention
Group B: Non Supervised Exercise InterventionActive comparator 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre (0 week), Post (12 week), Post Surgery (3 month)2
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)
Time frame
Pre (0 week), Post (12 week), Post Surgery (1 month), Post Surgery (3 month)3
Pain
Pain will be assessed using a visual analog scale (VAS), where 0 represents no pain and 10 represents maximum pain.
Time frame
Pre (0 week), Post (12 week), Post Surgery (1 month), Post Surgery (3 month)Secondary outcomes
1
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.
Time frame
Pre (0 week)2
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.
Time frame
Pre (0 week)3
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.
Time frame
Pre (0 week), Post (12 week), Post Surgery (3 month)4
Body Composition
Muscle mass, fat mass, weight, and body mass index (BMI) will be evaluated using a digital bioimpedance scale (TANITA BC 545N).
Time frame
Pre (0 week), Post (12 week), Post Surgery (3 month)Locations
Sponsors and contacts
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University of Seville
Lead sponsor
Hospitales Universitarios Virgen del Rocío
Collaborator
Source ClinicalTrials.gov
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