Physiotherapeutic Intervention in Children With Chronic Functional Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether physiotherapy is effective in the treatment
      of the chronic functional constipation in children.
    

Detailed 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.
    

Intervention name(s): diaphragmatic breathing, isometric training of the abdominal muscles and abdominal massage
Intervention type(s): Other
Intervention description(s): Exercises will be conducted by one physiotherapist. A one-minute rest period will be observed between each series. Isometric training of the abdominal muscles: This will consist of a contraction of the upper abdomen muscle and diaphragm and the simultaneous relaxation of the lower abdomen. 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. Breathing exercises: 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,. Two series will be completed, with ten repetitions. Abdominal massage: The physiotherapist will perform slow circular clockwise movements, along the line of the colon, 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Physical Therapy; Chronic Functional Constipation; Children