Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00906971 |
| Other study ID # |
posca-832 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
May 19, 2009 |
| Last updated |
November 6, 2012 |
| Start date |
March 2009 |
| Est. completion date |
April 2010 |
Study information
| Verified date |
November 2012 |
| Source |
Universidade Federal de Pernambuco |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Brazil: National Committee of Ethics in Research |
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to determine whether physiotherapy is effective in the
treatment of the chronic functional constipation in children.
Description:
1) INTRODUCTION
Chronic functional constipation (CFC) is a common problem in the pediatric population,
affecting approximately 25% of those seeking specialized medical care. The complaint is
multifactorial, involving environmental, psychological and physiological factors, which
interact with the brain-gut axis, but the retention of stools secondary to the
pain-restraint cycle, associated to the fear and anxiety of the resulting bowel movement, is
important in the development and management of CFC.
Difficulties involved in the management of CFC are common. Conventional treatment includes
educational measures, disimpaction, laxatives and an increased fiber intake. However, these
measures have not necessarily been beneficial for all cases, with a cure ratio of between 50
and 60%, and around one third of all patients become long-term sufferers of constipation.
The muscles of the intestine contribute to atonic constipation - sluggish or flaccid muscles
in the bowel or rectum, or spasticity - increased muscle tone due to emotional stress. These
two factors are both present in patients with CFC. Bowel movement depends on the interlinked
functions of abdominal muscles, the pelvic floor and diaphragmatic breathing: contraction of
the diaphragm, abdominal distention resulting from the voluntary relaxation of the abdominal
wall and the pelvic floor lead to increased intra-abdominal and peristaltic pressure and
relaxation of the external anal sphincter (EAS), thus culminating in bowel movement. Added
to which, activity of the parasympathetic autonomic nervous system causes an increase in
gastrointestinal motility and relaxation of the sphincters. The superficial and deep
abdominal muscles, in addition to the diaphragm and muscles of the pelvic floor, form a
single muscle unit that assists regular bowel movement, and should all be worked together in
order to stimulate peristalsis. Therefore, a combination of exercises that stimulate and
relax the abdominal muscles, indirectly acting on the pelvic floor, coordinated with
diaphragmatic breathing, may trigger contraction of the intestinal and rectal muscles,
therefore bringing relief to patients with CFC.
Multidisciplinary treatment can complement the conventional treatment of CFC. Physiotherapy
exercises for the abdominal muscles and diaphragm plus abdominal massage may reverse any
changes brought on by CFC. Retraining the intestinal functions is brought about due to two
main effects:
1. mechanical - stimulating colonic movements, improving coordination of the muscles
involved in bowel movement, thus encouraging fecal propulsion and increasing abdominal
muscle tone;
2. neurological - parasympathetic stimulation increases muscle motility, while sympathetic
stimulation reduces anxiety, promoting relaxation and increasing endogenous serotonin,
thus reducing discomfort and increasing a sense of well-being. However, little evidence
of physiotherapy exercises applied to patients with CFC is available in the literature,
and randomized, controlled clinical trials are needed.
The aim of the present study is to assess the effect of muscular training, abdominal massage
and diaphragmatic breathing in patients with CFC. The hypothesis is that exercises for
training abdominal muscles, a diaphragmatic breathing pattern and abdominal massage increase
the frequency of bowel movements and reduce episodes of fecal incontinence in patients with
CFC.
2) METHODS
Design overview
A randomized, controlled trial was conducted with two parallel groups. In the physiotherapy
group, physiotherapy exercises will be employed (isometric training of the abdominal
muscles, diaphragmatic breathing exercises and abdominal massage) together with conventional
treatment (disimpaction, when necessary, a high-fiber diet, laxatives and toilet training).
Patients in the medication group will be only submitted to conventional treatment.
Disimpaction will be conducted with phosphate saline solution (once a day, from one to five
days, according to patient needs). During toilet training, the patient will be instructed to
sit on the toilet for at least five minutes, with support for the feet, after the three main
meals of the day.
Setting and participants
The trial will carried out in the Pediatric Unit at Hospital das Clínicas at Federal
University of Pernambuco (UFPE), which provides patients with tertiary health care. Children
and adolescents aged between 4 and 18 years take part in the study.
For inclusion in the study, patients will be considered with CFC presented two or more of
the following parameters in the basal period, at least once a week, during the previous
two-month period, according to Rome III criteria: two or less bowel movements per week, at
least one episode of fecal incontinence per week, reports of retentive behavior, episodes of
hard stools or pain during bowel movements, presence of a large quantity of stool in the
rectum and large diameter stools, which could obstruct the toilet. Exclusion criteria will
be patients who take medication that caused constipation, patients with organic causes and
children with cognitive problems to perform the protocol. Children aged four to six years
were assessed for their ability to complete the physiotherapy exercises. This assessment
will consist of a few repetitions of the protocol conducted shorter after completing the
forms, where difficulty in completing protocol exercises will considered non-inclusion
criteria, so as not to interfere with the results.
Parents or guardians will sign the terms of informed consent after receiving information on
the aims and procedures of the study. A specially structured form will apply regarding signs
and symptoms of CFC. The study was approved by the Ethics Committee for Research involving
human beings at the Centro Integrado de Saúde Amaury de Medeiros (Registration 085/08).
Randomization and interventions
A table of random numbers will be created in the computer by someone not involved in the
study, from which will determined the random distribution sequence of the patients. This
information will remain the exclusive knowledge of one research assistant, who will use
these numbers to allocate patients by order of study entry, immediately after giving their
consent to take part. This will only made known to the researchers after statistical
analysis.
- Physiotherapy + medication group (Intervention) Physiotherapy exercises will be
conducted by one single generalist physiotherapist, specially trained to perform the
exercises during the three months prior to the study. Twelve individual sessions will
be held twice a week, each lasting forty minutes, and adherence will be confirmed only
if patients attended all twelve sessions. A one-minute rest period will be observed
between each series of exercises.
- Isometric training of the abdominal muscles The aim of the training will be to
increase intra-abdominal pressure (which compresses the intestines) and the
colonic propulsive force during voluntary effort. Considering that there is
indirect synergic activation between the pelvic floor muscle and the lower
abdominal muscle, the operation of the voluntary isometric contraction of the
upper abdomen and the simultaneous relaxation of the lower abdomen improves muscle
coordination, relaxation of the pelvic floor and relaxation of the external anal
sphincter, thus optimizing bowel movement. This consist of a contraction of the
upper abdomen muscle and diaphragm and the simultaneous relaxation of the lower
abdomen, under the supervision of the physiotherapist. Training will be carried
out in two manners: with the patient lying in a left lateral decubitus position
with the hip and knee flexed at 90º and sitting. In the lying method, training
began with two series of eight contractions and relaxations, into the third week,
and then will increase to two series of twelve contractions and relaxations, and
will remain so until the sixth week. In the sitting method, training will begin
with one series of three contractions and relaxations lasting ten seconds,
increasing to five repetitions in the third week, and remaining so until the sixth
week. The exercise will considered successfully carried out when a protrusion of
the lower abdomen was visible, indicating the simultaneous relaxation of the lower
abdomen and the pelvic floor, from which point the series was initiated.
- Breathing exercises The aim was to achieve a regular pattern of abdominal
breathing and strengthen the abdominal muscle, improving coordination between
breathing, the abdominal and anal muscles and colonic propulsion. Standard
diaphragmatic breathing will achieve with a modified exercise, under the
supervision of the physiotherapist, with the patient in a seated position, with
one hand placed on the abdomen and the other on the thorax, and will be instructed
to breath in slowly, deeply and progressively for 6 to 8 seconds, retain the air
for 10 seconds and exhale slowly for 6 to 8 seconds. Two series will be completed,
with ten repetitions, and the exercise was considered successfully performed when
greater mobility of the hand placed on the abdomen achieves, compared to minimal
or no mobility of the hand on the thorax, from which point the series was
initiated.
- Abdominal massage The aim will be perform propulsive abdominal massage to promote
colonic and rectal motility, and train the intestinal function and bowel movement.
The physiotherapist will perform slow circular clockwise movements, along the line
of the colon, applying constant moderate pressure to the abdomen with a regular
tennis ball, remaining on each point for one minute, beginning with the ascending
colon moving in the direction of the sigmoid colon.
- Medication and guidance Patients will use a laxative (magnesium hydroxide), for
which the dosage will vary according to individual needs (a minimum of 2 ml/kg),
and will receive guidance regarding fiber-rich foods, water and toilet training.
Patients will attend weekly consultations with a pediatric gastroenterologist, who
will be unaware of which patients belonged to which treatment group, since
patients were only receiving clinical follow-up.
- Medication Group (Control) Patients in this group will be monitored on a weekly basis
by a pediatric gastroenterologist, who will be unaware of which patients belonged to
which treatment group, since patients were only receiving clinical follow-up. All
patients will be prescribed a laxative (magnesium hydroxide), for which the dosage
varied according to individual needs (a minimum of 2 ml/kg), and will receive guidance
regarding fiber-rich foods, water and toilet training, under the same conditions as
patients in the intervention group.
Sample size Since there are no other similar studies, the sample was calculated from a study
that instructed children to achieve bowel movements sitting on the toilet. A reduction was
encountered of 80% in fecal incontinence in the intervention group and 55% in the control
group. The effect on the reduction of fecal incontinence (< one/week) was estimated at 25%
in favor of the intervention. Epi-Info 6.04 was employed, using p=5% power=80%, which
resulted in 72 participants.
Outcomes and follow-up The frequency of bowel movement and retentive fecal incontinence will
be the primary outcome measures. Pain and increased effort for bowel movement, consistency
of stools and retentive behavior will be secondary outcome measures.
During follow-up, parents or guardians will keep a diary describing the intestinal habits of
the children. These data will be checked and handed in weekly to the research assistant.
Statistical analysis Statistical analysis to compare the two groups at the end of the
follow-up period with regard to the primary and secondary outcome measures will be blind, by
intention-to-treat, considering loss of follow-up as treatment failure. In such cases, at
the end of the follow-up period, the frequency of bowel movement and fecal incontinence will
be recorded, as well as the response to other variables, reported at the beginning of the
study. The chi-squared test will be used for proportions and the Student t-test for
numerical variations with normal distribution (the Bartlett test was used to verify the
homogeneity of the variance). The Mann-Whitney test will be used for numerical variables
with non-normal distribution. Statistical significance will set at p<0,05. All analysis will
be performed using the Epi-Info™, version 6.04d (CDC - Center of Disease Control and
Prevention, Atlanta, USA and WHO World Health Organization, Geneva, swirtzerland).
An intragroup treatment additional exploratory analysis will be also conducted to assess the
function of retentive behaviour and fear of bowel movement in the frequency of bowel
movement at the end of treatment.
