Document Date: 01/18/2020. Human Subjects protection review board approval date: 07/15/2018 - EFFECT OF PREOPERATIVE GRADUATED ABDOMINAL ...
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Official Title of Study: -
EFFECT OF PREOPERATIVE GRADUATED
ABDOMINAL EXERCISES AND RUSSIAN
STIMULATION ON MUSCLE STRENGTH
AFTER VENTRAL HERNIOPLASTY
Document Date: - 01/18/2020.
Human Subjects protection review board approval
date: - 07/15/2018
1INTRODUCTION
Herniation refers to protrusion of an organ or tissue through an opening
that may be natural or caused by a tear in the abdominal wall. Ventral abdominal
hernia is a commonly acquired condition caused by the migration of viscera
through a tear in the abdominal wall. The tear may be dorsal or ventral in the
flank, along the costal arch or between the last few ribs. Ventral hernias commonly
result from traumas caused by horn thrust, kick or violent contact with blunt
objects or by an abdominal distension due to pregnancy or violent straining during
parturition (Karanja et al., 2014).
Primary ventral hernias and ventral incisional hernias have been a challenge
for surgeons throughout the ages. In the current era, incisional hernias have
increased in prevalence due to the very high number of laparotomies performed in
the 20th century. Even though minimally invasive surgery and hernia repair have
evolved rapidly, general surgeons have yet to develop the ideal, standardized
method that adequately decreases common postoperative complications, such as
wound failure, hernia recurrence and pain. While the incidence of incisional
ventral hernias has increased as abdominal surgery has become more prevalent
(Vorst et al., 2015).
Ventral hernias include all hernias in the anterior and lateral abdominal wall.
Midline defects include umbilical, paraumbilical, epigastric, and hypogastric
hernias. Umbilical hernias are by far the most common type of ventral hernia; they
are usually small and are particularly common in women. Paraumbilical hernias
are large abdominal defects through the linea Alba in the region of the umbilicus
and are usually related to diastasis of the rectus abdominis muscles. Epigastric
hernias and hypo gastric hernias occur in the linea Alba above and below the
umbilicus, respectively (Aguirre et al., 2005).
2Hernias are very common conditions that most surgeons diagnose and treat
in daily practice. Umbilical hernias account for 5-7%of all hernias; however, there
is data suggesting a substantially higher rate, up to14%. Most umbilical hernias are
acquired; the associated major risk factors are: increased intra-abdominal pressure
as noted in obese patients, pregnancy, the presence of an intra-abdominal mass,
and ascites caused by cirrhosis, or peritoneal carcinomatosis the correlation
between the presence of an umbilical/Para umbilical hernia and an intra-abdominal
malignancy is solely based on prior case reports (Barczynski et al., 2014).
Umbilical hernia is a rather common surgical problem. Approximately 10%
of all primary hernias comprise umbilical and epigastric hernias. Recurrence may
develop even in cases where a prosthetic mesh is used. Recurrent umbilical hernias
often tend to enlarge faster than primary ones and may behave as incisional
hernias. It has a tendency to be associated with high morbidity and mortality in
comparison with inguinal hernia because of the higher risk of incarceration and
strangulation that require an emergency repair (Kulacoglu et al., 2015).
Ventral hernias continue to be one of the most prevalent complications after
abdominal surgery, with an incidence of 15%. Primary suture repair has met with
dismal outcomes, with recurrence rates 50%.Different techniques of herniorrhaphy
have been developed, but the use of synthetic mesh has been a major contributor to
decreased recurrence rates, ranging from 10% to 23%. In addition to the advent of
synthetic mesh, the adaptation of laparoscopy to ventral hernia repairs has led to
shortened hospital stays, decreased pain¸ faster recovery times, decreased wound
morbidity, and lower recurrence rates (Bhanot et al., 2013).
The abdominal muscles have a role to play in all movement. This makes
perfect sense considering the higher number of nerve innervations into these
3muscles. To train the abdominal muscles effectively it requires far more than
merely performing hundreds or even thousands of flexion movements, in the
pursuit of attaining the most optimal results one must realize and understand that
abdominal training should be of a holistic approach (George, 2012).
Use of exercise prior to an acute stress or surgery has emerged as a viable
perioperative risk reduction strategy. This concept, known as prehabilitation, was
first used in sports medicine to reduce the impact of an injury prior to its
occurrence. It has been explored as a method of preoperative optimization in
patients undergoing elective intra-abdominal surgery (Knight et al., 2017).
The Russian current is used for enhancing muscle; the muscular fiber by the
electric stimulation is used in Type II as Type I oppositely with the voluntary
contraction. According to Hudlicka et al, the property of muscular contraction
changes by long-term electric stimulation with low frequency in Type IIb, and
these changes are related to the stimulus duration, so if the long-term low-
frequency current is applied for more than two weeks in minimum, it will change
physiologically into I type fiber (Jung et al., 2014).
Statement of the Problem: -
- Are the preoperative graduated abdominal strengthening exercises able to
improve abdominal muscle strength after ventral hernioplasty?
- Is the Russian stimulation for abdominal muscles able to improve
abdominal muscle strength after ventral hernioplasty?
- Is the combination between preoperative graduated abdominal
strengthening exercises able to improve abdominal muscle strength after
ventral hernioplasty?
4Purpose of the study:
The purpose of the study will be focused on investigation of the effect of
preoperative graduated abdominal strengthening exercises and Russian stimulation
on the abdominal muscles strength after ventral hernioplasty.
Significance of the study:
The need of this study will be designed from the lack of the primary related
researches about the role of preoperative graduated abdominal strengthening
exercises and Russian stimulation on abdominal muscle strength after ventral
hernioplasty.
The recurrence rate after standard repair of ventral hernias may be as high
as 12-52%, and the wide surgical dissection required often results in wound
complications (Park et al., 2003).
Umbilical hernia has gained little attention in comparison with other types
of hernias (inguinal, postoperative); however, the primary suture for umbilical
hernia is associated with a recurrence rate of 19-54% (Kiudelis et al., 2008).
Physical conditioning including overall fitness and obesity is associated
with ventral hernias. Obese patients are at increased risk of hernia formation,
hernia incarceration. As well as all adverse events following ventral hernia repair
including wound complications, surgical site infections, and hernia recurrence.
While preoperative physical conditioning and weight loss programs have been
shown to be effective in achieving weight loss, studies have demonstrated variable
results on the impact on outcomes. In addition, these studies have largely been
performed in bariatric surgery, cardiac surgery, and orthopedic surgery and no
studies have evaluated this in patients with ventral hernias. It is unclear if the
5effectiveness of these programs to improve weight loss and physical conditioning
can be translated to ventral hernia repair (Holihan et al., 2016).
Delimitations:
The study will be delimited to the following respects:
Subjects:
Sixty patients with ventral hernia, their age ranged from 20 to 45 years will be
selected from South Valley University Hospital.
The patients will classify into four groups:
Group A (study group): will receive graduated abdominal strengthening
exercises for 30 min., 3 times per week for 6 weeks preoperatively.
Group B (study group): will receive Russian stimulation on abdominal
muscles for 30 min., 3 times per week for 6 weeks preoperatively.
Group C (study group): will receive combination between graduated
abdominal strengthening exercises and Russian stimulation on abdominal
muscles for 30 min., 3 times per week for 6 weeks preoperatively.
Group D (control group): will be instructed to presume in normal activities
of daily living preoperatively, without abdominal exercises or Russian
stimulation.
Equipment Used:
The main equipment that will be used in the study will be delimited as
following:
Measurement Equipment:
- Biodex 3, Isokinetic Dynamometer System (with the back/abdominal unit).
- Ultrasonography System.
Therapeutic Equipment and Tools:
The equipment that will be used for treatment protocol includes:
6- Swiss ball and elastic thera band.
- Mat, wedges, and wall bar.
Basic Assumption:
It will be assumed that:
- All subjects will continue in the study.
- All patients will follow the instructions during the treatment.
- All patients will exert maximum effort during the test and treatment period.
- Environmental factors such as cold, noise, etc will be controlled during
evaluation and treatment sessions.
- The clinical methods of measurement will be valid and reliable.
Hypothesis of the study:
It will be hypothesized that:
- The preoperative graduated abdominal strengthening exercises have a
positive effect on abdominal muscle strength after ventral
hernioplasty.
- The Russian stimulation has a positive effect on abdominal muscle
strength after ventral hernioplasty.
Definitions of terms:
The following terms will be defined for the clear understanding of the
terminology that will be used in the present study:
Abdominal Wall:
It is a complex composite structure composed of various layers which vary
depending on specific anatomical location (e.g., medial/lateral, above/below the
arcuate line) (Deeken et al., 2017).
Intra-abdominal Pressure (IAP):
7It is the steady-state pressure concealed within the abdominal cavity, IAP
should be expressed in mmHg and measured at the end of exhalation in the supine
position after ensuring that abdominal muscle contractions are absent and with the
transducer zeroed at the level where the midaxillary line crosses the iliac crest
(Malbrain et al., 2016).
Isokinetic Testing Dynamometer:
It is testing performed with dynamometer that maintains the lever arm at a
constant angular velocity, this type of strength evaluation account for velocity of
movement that is controlled with free weights and machines, dynamometers resist
generated forces proportionally to that which is applied (Kraemer et al., 2006).
Ventral Hernia:
It describes any protrusion of abdominal viscera, most often a piece of
intestine, through the anterior abdominal wall, eventration of the anterior
abdominal wall is a bulging that occurs from either paralysis of a portion of the
abdominal musculature or congenital absence (Bathla et al., 2012).
Strength training (strengthening exercise):
It is a systematic procedure of a muscle or muscle group lifting, lowering, or
controlling heavy loads (resistance) for a relatively low number of repetitions or
over a short period of time (Kisner et al., 2012).
Russian stimulation:
It is alternating currents with a frequency of 2.5 kHz that are burst
modulated at a frequency of 50 Hz with a 50% duty cycle. It is applied for a 10‐sec.
“on” period followed by a 50‐sec. “off” period for 10 min. (Ganesh et al., 2018).
Ultrasonography:
A reliable method of measuring the cross-sectional area and volume of the
muscles and is applied to analyze skeletal muscle adaptation to muscle
strengthening programs. It used to measure and analyze the structural
8characteristics of the muscles as muscle function and thickness, pennation angle,
and fascicle length (Yu et al., 2015).
SUBJECTS, MATERIALS AND METHODS
In this part of the study, the materials and methods will be presented under
the following headings: subjects, equipments, procedures of the study and the
statistical procedures.
1. Subjects:
Sixty patients with ventral hernia, preoperatively, their age ranged from 20
to 45 years will be selected from South Valley University Hospital and randomly
distributed into four equal groups.
1.1 Design of the study:
In this study the patients will be randomly assigned into four equal groups (15
patients for each group):
1.1(a).Group A (Study group):
This group includes 15 patients with ventral hernia who will receive
graduated abdominal strengthening exercises for 30 min., 3 times per week for 6
weeks preoperatively.
1.1(b).Group B (Study group):
This group includes 15 patients with ventral hernia who will receive
Russian stimulation on abdominal muscles for 30 min., 3 times per week for 6
weeks preoperatively.
1.1(c). Group C (Study group):
This group includes 15 patients with ventral hernia who will receive combination
between graduated abdominal strengthening exercises and Russian stimulation on
abdominal muscles for 30 min., 3 times per week for 6 weeks preoperatively.
1.1(d). Group D (Control group):
9This group includes 15 patients with ventral hernia who will instruct to presume in
normal activities of daily living preoperatively, without abdominal exercises or
Russian stimulation.
1.2 Criteria for the patient selection:
1.2. (a).Inclusion Criteria:
The subject’s selection will be according to the following criteria:
- Age range between 20-45 years.
- All patients desire an elective surgical repair.
- All patients were diagnosed with ventral hernia (Grade II & III) based on
surgeon assessment.
- All patients will participate in the study.
- All patients enrolled to the study will have their informed consent.
- All patients are able to act in abdominal training program.
- All patients are able to follow orders during testing and training times.
1.2. (b).Exclusion Criteria:
The participants will be excluded if they meet one of the following criteria:
- A strangulated hernia.
- History of surgical interference (abdominal surgery) less than one year.
- Liver cirrhosis with or without ascites.
- Hip or spine deformities or contractures.
- Bowel obstruction, peritonitis, or perforation.
- Local or systemic infection.
- Patient is pregnant or intended to become pregnant during this period.
- Patient has indication for urgent surgery determinate by surgeon.
102. Equipments:
2.1. Measurement equipment:
2.1. (a). Biodex 3, isokinetic Dynamometer System (with back/abdominal unit):
The Biodex® dynamometer studies muscle strength during isokinetic
movement, which is a movement with a constant angular velocity within a certain
range against a changing resistance (Den Hartog et al., 2010).
Isokinetic dynamometers may be used as scientific devices for testing,
comparing, and confirming injured or treated body parts. Indeed, the constant
technological advances over the past 15 yr facilitated the development of highly
effective dynamometers usable for the assessment and rehabilitation of most joints
in the upper and lower limbs. These devices are regularly used in osteoarticular
disorders or in the framework of sports training programs. Most of the isokinetic
machines used in pathology are rotating dynamometers. Results of an isokinetic
assessment are generally expressed as the peak torque value developed by the
tested muscle group. It is also possible to evaluate the work provided by the same
muscle group and the power developed at the joint (Jee et al., 2015).
2.1. (b). Ultrasound imaging (USI):
A real-time ultrasound B-scanner with a linear array transducer was used to
obtain images of the abdominal muscles. The penetration depth was 5.39 cm at a
sampling frequency of 7.5 MHz. The transducer placed on the anterolateral wall of
the abdomen between the iliac crest and the costal margin, perpendicular to the
longitudinal axis of the body, at rest, the fascial borders of the 3 muscles; the
oblique external (OE), oblique internal (OI), and transversus abdominis (TrA)
appeared parallel on the screen (Linek et al., 2017).
11Ultrasound is a reliable tool that is used to evaluate abdominal muscles in
both adult and adolescents. It can be used to asses both muscle size and
contraction. In other words, gives detailed information regarding isometric muscle
contractions and muscle activation, even low levels, though difference between
moderate and strong contractions can go unobserved. In their study, Hodges et al
suggested US as a low cost non- invasive modality that can be used in examining
deep abdominal muscles (Hodges et al., 2003).
To have a reliable measure, 3 thickness measurements taken at the end of
expiration on both body sides should be done for transversus abdominis, internal
oblique and external oblique in the supine, sitting, and standing positions. A
recommended position for the assessment is the crock lying position to allow for
relaxation of the anterior and posterior musculo-fascial trains (Linek et al., 2014).
2.2. Therapeutic equipment:
2.2. (a). Graduated Abdominal Exercises:
The following equipments will be used to achieve treatment approaches:
1. Exercise mat and inflatable Swiss ball 55 cm & 65 cm diameter.
2. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from
light to very heavy (yellow, red, blue, green, and gray colors).
2.2. (b). Russian Stimulation:
Russian current became popular to a large Extent as a result of the activities
of Kots, who claimed force gains of up to 40% in elite athletes as a result of what
was then a new form of stimulation. Kots’ argument for the use of electrical
stimulation combined with voluntary exercise was that the commonly used
exercise programs build muscle bulk and force (Ward et al., 2002).
12The Russian current is used for enhancing muscle; the muscular fiber by the
electric stimulation is used in Type II as Type I oppositely with the voluntary
contraction. According to Hudlicka et al, the property of muscular contraction
changes by long-term electric stimulation with low frequency in Type IIb type
fiber, and these changes are related to the stimulus duration, so if the long-term
low-frequency current is applied for more than two weeks in minimum, it will
change physiologically into I type fiber (Jung et al., 2014).
3. Procedures of the study:
3.1. Measurement procedures:
3.1. (a). Isokinetic measurement:
The evaluation procedures will be performed at faculty of physical therapy,
south valley university, Laboratory of Isokinetic.
Every patient will be instructed about the procedures of the evaluation and
training.
The environment of evaluation and training will be constant.
The patients in all groups will be assessed 4 times, the first assessment will
done 6 weeks preoperatively or before beginning treatment program, and the
second assessment will done one week preoperatively, third assessment will
done 2 months postoperatively, while fourth assessment will done 4 months
postoperatively.
The optimal position is the subject lay supine on a movable bench in a bent
knee position. The lever arm of the isokinetic dynamometer was set at 180
degrees (horizontal with the ground) and the padded extension was placed
just below the nipple line on the lower third of the sternum. The height of
the bench was adjusted for each subject so that the extension arm remained
at 180 degrees. Each subject was given several practice trials to make sure
13the position of the lever arm was comfortable on their chest. Subjects then
performed five isometric contractions, with approximately 30 seconds
between each repetition. The average torque for the highest two repetitions
was used in the analysis (Foster et al., 2005).
3.1. (b). Ultrasound imaging:
Every patient will be instructed about the procedures of the evaluation and
training.
The environment of evaluation and training will be constant.
The patients in all groups will be assessed 4 times, the first assessment will
done 6 weeks preoperatively or before beginning treatment program, and the
second assessment will done one week preoperatively, third assessment will
done 2 months postoperatively, while fourth assessment will done 4 months
postoperatively.
A real-time ultrasound B-scanner with a linear array transducer was used to
obtain images of the abdominal muscles. The penetration depth was 5.39 cm
at a sampling frequency of 7.5 MHz. The transducer was always placed on
the anterolateral wall of the abdomen between the iliac crest and the costal
margin, perpendicular to the longitudinal axis of the body, at rest, the fascial
borders of the 3 muscles; the oblique external, oblique internal, and
transversus abdominis appeared parallel on the screen. Measurements of the
thickness of the 3 muscles at rest were made in the supine rest position. In
this position, the knees of the examined individuals were extended and the
upper limbs placed along the sides of the trunk. The thickness of the muscles
was stored at the end of normal expiration. All images were saved on an
external drive in jpg format (Linek et al., 2017).
143.2. Therapeutic procedures:
3.2.(a). Procedures of Graduated Abdominal Exercises:
All patients will be instructed to keep glottis open and to exert activity on
exhalation as much as possible.
Activation of Rectus Abdominis:
Starting Position: Supine with back and lower limbs supported on a wedge
with restraining belts attached to the patients.
Procedure: Patients will be instructed to curl up trunk and raise lower
limbs in low intensity isometric contraction for 10 sec., the resistance
applied by the belts attached around patients.
Exercise Repetitions: 20 repetitions (Hold for 10 sec. and rest for 10 sec.).
Graduation of Exercise: The repetitions will be increased by one repetition
each week and hold time will be increased by 2 sec. each week.
Posterior Pelvic Tilt:
Starting Position: Crock lying with hands placed over ASIS on each side.
Procedure: The patient will ask to draw the pubic symphysis towards the
umbilicus with emphasis on anterior musculature contracting.
Exercise Repetitions: 20 repetitions (Hold for 10 sec. and rest for 10 sec.).
Graduation of Exercise: The repetitions will be increased by one repetition
each week and hold time will be increased by 2 sec. each week.
Rotational Planks:
Starting Position: Prone with body held suspended on flexed elbow and
feet.
15 Procedure: The patient should be keep elbows tucked in within alignment
of trunk to limit latissimus dorsi contraction.
- The patient asked to hold lumbar spine in neutral position.
- Hold position for 20 sec. in prone position then ask patient to rotate to
left and hold lumbar spine in neutral position for 20 sec. then rotate to
right and hold lumbar spine in neutral position for 20 sec. then return to
prone position and hold for 20 sec.
Exercise Repetitions: 10 repetitions (Hold for 20 sec. for each position).
Graduation of Exercise: The repetitions will be increased by one repetition
each week and hold time will be increased by 2 sec. each week.
Abdominal Crunch on Swiss Ball with Elastic Resistance:
Starting Position: Patient site on Swiss ball then walk feet away while
going lying down to allow ball stop under lumbar spine area. The feet
placed 2 feet apart while knees bent at 90 degrees. Hands placed at
shoulder level grasping the elastic resistance handles.
Procedure: Ask patient to curl the head, neck and shoulders up and
towards the pelvic region (concentric phase). Then patient return slowly to
starting position (eccentric phase).
- Several elastic tubing (Thera-band) with resistance ranges from light to
very heavy (yellow, red, blue, green, and gray colors) will be used
according to results of a 10 repetition maximum test to detect which
elastic tube to start with it.
Exercise Repetitions: 40 repetitions (4 sets of 10 repetitions). With 1 min.
rest after each set.
Graduation of Exercise: The repetitions will be increased in each set by 1-
2 repetitions each session.
- The Elastic tube resistance should be tested every week.
16Graduation of Exercises performance during rehabilitation period was modified
from (Ellsworth et al., 2014, Sundstrup et al., 2012, Marchetti et al., 2011, and
Kachingwe et al., 2008).
3.2.(b). Procedures of Russian Stimulation:
Device: ASTAR Etius ver. 3.0.
Patient position: Semi-recumbent.
Electrode positions : Place one of the electrodes over the center of the muscle belly
and the other electrode distal on the muscle belly.
Carrier frequency: 2,500 Hz.
Burst modulated: The bursts are delivered at 50 bursts per second with burst
duration of 10 msec and an interburst interval of 10 msec.
Duration: phase duration 200 μsec & cycle duration 400 μsec.
Duty cycle: 50%.
Protocol: 10/50/10 (10-second contraction time, 50-second off-time, 10
repetitions).
Frequency of treatment: three times weekly.
4. Statistical procedures:
4.1. Descriptive statistics:
In this study, the descriptive statistics (the mean and the standard deviation)
will be calculated for all subjects in all groups of the study to determine the
homogeneity of the groups.
4.2. Analytical statistics:
In this study, t-test will performed for comparison of the mean age,
between the groups.
17 T test will performed for comparison of pre and post operative mean values
of abdominal muscles peak torque between control and study groups.
T test will performed for comparison of pre and post operative mean values
of abdominal muscles thickness between control and study groups.
Paired t test will performed for comparison between pre and post treatment
mean values of abdominal muscles peak torque in each group.
Paired t test will performed for comparison between pre and post treatment
mean values of abdominal muscles thickness in each group.
ANOVA with repeated measures will be performed for comparison
between pre-operative, post-exercise and post-operative mean values of
abdominal muscles peak torque.
ANOVA with repeated measures will be performed for comparison
between pre-operative, post-exercise and post-operative mean values of
abdominal muscles thickness.
The level of significance for all statistical tests will be set at p > 0.05.
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