Physiotherapeutic Intervention in Children With Chronic Functional Constipation
This study has been completed.
Sponsor:
Universidade Federal de Pernambuco
Information provided by (Responsible Party):
Carlos Andre Gomes Silva, Universidade Federal de Pernambuco
ClinicalTrials.gov Identifier:
NCT00906971
First received: May 19, 2009
Last updated: November 6, 2012
Last verified: November 2012
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Purpose
The purpose of this study is to determine whether physiotherapy is effective in the treatment of the chronic functional constipation in children.
| Condition | Intervention |
|---|---|
|
Chronic Constipation |
Other: diaphragmatic breathing, isometric training of the abdominal muscles and abdominal massage |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Physiotherapeutic Intervention in Children With Chronic Functional Constipation |
Resource links provided by NLM:
Further study details as provided by Universidade Federal de Pernambuco:
Primary Outcome Measures:
- Frequency of Defecation. [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]The patients (or their parents) received a bowel diary and they fulfilled about frequency of defecation weekly.
- Retentive Fecal Incontinence. [ Time Frame: six weeks ] [ Designated as safety issue: Yes ]
Retentive fecal incontinence is the lose of fecal while the patient tries to avoid the bowel movement.
The patients (or their parents) received a bowel diary and they fulfilled about frequency of episodes of retentive fecal incontinence weekly.
| Enrollment: | 72 |
| Study Start Date: | March 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Laxatives
Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
|
Other: diaphragmatic breathing, isometric training of the abdominal muscles and abdominal massage
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Less than 2 per week defecation
- Fecal incontinence
- Retentive behavior
- Pain at defecation and
- Hard stools
Exclusion Criteria:
- Medication use (calcium, antacid, diuretic and hematinic)
- Organic causes (spina bifid, hypothyroidism, hirschusprung disease, developmental delay neuropsychomotor, kidney disease and metabolic diseases)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Carlos Andre Gomes Silva, Master, Universidade Federal de Pernambuco |
| ClinicalTrials.gov Identifier: | NCT00906971 History of Changes |
| Other Study ID Numbers: | posca-832 |
| Study First Received: | May 19, 2009 |
| Results First Received: | September 14, 2012 |
| Last Updated: | November 6, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Universidade Federal de Pernambuco:
|
Physical Therapy Chronic Functional Constipation Children |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 21, 2013