Trial Outcomes & Findings for Physiotherapeutic Intervention in Children With Chronic Functional Constipation (NCT NCT00906971)
NCT ID: NCT00906971
Last Updated: 2012-11-12
Results Overview
The patients (or their parents) received a bowel diary and they fulfilled about frequency of defecation weekly.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
six weeks
Results posted on
2012-11-12
Participant Flow
The trial was carried out in the Pediatric Unit at Hospital das Clínicas at Federal University of Pernambuco (UFPE) between May 2009 and May 2012.
Participant milestones
| Measure |
Medication
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.
|
Physiotherapy + Medication
Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
28
|
33
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
Reasons for withdrawal
| Measure |
Medication
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.
|
Physiotherapy + Medication
Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Physiotherapeutic Intervention in Children With Chronic Functional Constipation
Baseline characteristics by cohort
| Measure |
Medication
n=36 Participants
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.
|
Physiotherapy + Medication
n=36 Participants
Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
4 >= 10 years
|
20 participants
n=5 Participants
|
25 participants
n=7 Participants
|
45 participants
n=5 Participants
|
|
Age, Customized
11 >= 18 years
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Frequency of defecations
|
2.9 days/week
STANDARD_DEVIATION 2.0 • n=5 Participants
|
2.9 days/week
STANDARD_DEVIATION 2.3 • n=7 Participants
|
2.9 days/week
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Retentive fecal incontinence
|
3.5 days/week
STANDARD_DEVIATION 2.6 • n=5 Participants
|
3.6 days/week
STANDARD_DEVIATION 2.8 • n=7 Participants
|
3.5 days/week
STANDARD_DEVIATION 2.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: six weeksThe patients (or their parents) received a bowel diary and they fulfilled about frequency of defecation weekly.
Outcome measures
| Measure |
Medication
n=36 Participants
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.
|
Physiotherapy + Medication
n=36 Participants
Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
|
|---|---|---|
|
Frequency of Defecation.
|
3.9 days/week
Standard Deviation 2.0
|
5.1 days/week
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: six weeksRetentive 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.
Outcome measures
| Measure |
Medication
n=36 Participants
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.
|
Physiotherapy + Medication
n=36 Participants
Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
|
|---|---|---|
|
Retentive Fecal Incontinence.
|
3.0 days/week
Standard Deviation 2.1
|
3.6 days/week
Standard Deviation 1.9
|
Adverse Events
Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physiotherapy + Medication
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carlos André Gomes Silva
Universidade Federal de Pernambuco
Phone: +55 83 9913-4949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place