Constipation - FunctionalconstipationNCT03106857
Effect of Weight Reduction on Constipation
A study testing Group A in people with Constipation - Functional, run by Ahlia University at 2 sites in Egypt.
Trial summary
In total, 125 women aged between 20 and 40 years were recruited in this study. Participants were considered eligible when they met the inclusion criteria of being diagnosed with functional constipation, as defined by the Rome Foundation. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Constipation - Functional
- What is being tested?
- Group A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 2 sitesEgypt
- Study dates
- Dec 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients whose BMI exceeded 30 kg/m2 were included.
- In addition, they fulfilled the ROM criteria of constipation, as follows:
- Suffered from any 2 or more of the following symptoms in the past 12 weeks (not necessarily consecutive), with the onset of symptoms at least 6 months prior to diagnosis:
- straining during at least 25% of defecations,
- lumpy or hard stools in at least 25% of defecations,
- sensation of incomplete evacuation for at least 25% of defecations,
Show all 12Show fewer
- sensation of anorectal obstruction/blockage for at least 25% of defecations,
- requirement of manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor muscles), and
- fewer than 3 defecations per week;
- Loose stools rarely occurred without the use of laxatives;
- Insufficient criteria for irritable bowel syndrome; and
- Women were sedentary (less than 1 hour/week of physical activity), with no evidence of participation in diet control/weight reduction programs within the last 6 months.
Who cannot join
- Patients with metabolic, endocrine, and neurologic constipation;
- current or past smokers;
- those with any orthopedic limitation; and
- those with congenital megacolon, pseudo-obstruction, and anorectal disorders were excluded from the study.
- Patients suffering from constipation due to drugs, disabled patients, and those who had undergone any abdominal surgery during the intervention or those who failed to complete the study protocol were also excluded.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Dr Dalia Kamel
Giza, Giza Governorate
Dr Sayed Tanatwy
Giza, Giza Governorate
About this study
Official title: A Proposed Physical Activity and Diet Control to Manage Constipation in Middle Age Obese Women
In total, 125 women aged between 20 and 40 years were recruited in this study. Participants were considered eligible when they met the inclusion criteria of being diagnosed with functional constipation, as defined by the Rome Foundation. The study was a randomized controlled trial carried out at Cairo University Hospital.Patients whose BMI exceeded 30 kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation.
Read the detailed description
In total, 125 women aged between 20 and 40 years were recruited in this study. Participants were considered eligible when they met the inclusion criteria of being diagnosed with functional constipation, as defined by the Rome Foundation. The study was a randomized controlled trial carried out at Cairo University Hospital.
Patients whose BMI exceeded 30 kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation, as follows: (1) Suffered from any 2 or more of the following symptoms in the past 12 weeks (not necessarily consecutive), with the onset of symptoms at least 6 months prior to diagnosis: a) straining during at least 25% of defecations, b) lumpy or hard stools in at least 25% of defecations, c) sensation of incomplete evacuation for at least 25% of defecations, d) sensation of anorectal obstruction/blockage for at least 25% of defecations, e) requirement of manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor muscles), and f) fewer than 3 defecations per week; (2) Loose stools rarely occurred without the use of laxatives; (3) Insufficient criteria for irritable bowel syndrome; and (4) Women were sedentary (less than 1 hour/week of physical activity), with no evidence of participation in diet control/weight reduction programs within the last 6 months.
Patients with metabolic, endocrine, and neurologic constipation; current or past smokers; those with any orthopedic limitation; and those with congenital megacolon, pseudo-obstruction, and anorectal disorders were excluded from the study. Patients suffering from constipation due to drugs, disabled patients, and those who had undergone any abdominal surgery during the intervention or those who failed to complete the study protocol were also excluded. All participants provided a written informed consent before enrolling in the study.
Study design and intervention:
Participants were randomly divided into 2 groups. Group A included 62 women who were following a suggested protocol of physical activity and a low caloric diet in addition to the routine standard care for constipation. The low caloric diet allowed 1000-1200 kcal/day, divided as follows: 50%-60% carbohydrates, 20% protein, <30% total fat, and 18 g of fiber /1000 Kcal. The diet plans were revised every 2 weeks and the diet was modified while ensuring that it was within the allowed caloric value, in addition to the routine standard care for constipation. Group B included 63 patients who received only the standard medical care for constipation and a low caloric diet as in Group A. Patients in both groups followed their program for 12 weeks.
Exercise intervention for Group (A) Each woman in Group A participated in the exercise training program for 12 weeks, 3 times per week, with each exercise session lasting for 60 minutes. The participants were instructed not to eat for 3 hours before the exercise session.
The exercise training program was in the form of walking on a treadmill without tightly grasping the rails, because this action seemed to reduce the workload during any stage of the exercise. To overcome this issue, the participants were asked to remove their hands from the rails, close their fists, and place only 1 finger on the rails to maintain balance once they were accustomed to walking on the treadmill.
The exercise session was started by a 10-minute warm-up, which involved walking without any resistance or inclination on the walkway of the treadmill, followed by 40 minutes of walking with 15 degrees of inclination and a speed adjusted to reach 20%-40% of the target heart rate (THR) in the first 6 weeks of the study; the speed was increased to reach 40%-60% THR in the next 6 weeks of the study. The session ended by 10 minutes of recovery period, in which the intensity of the exercise was reduced to the level of the warm-up.
The assessment procedures performed before and after 12 weeks of intervention consisted of the following:
- The Patient Assessment of Constipation - Symptom (PAC-SYM) is a reliable and valid 16, 17 tool to measure the patient's perspective of constipation symptoms in terms of the frequency and severity. It is a 12-item self-reported measure, which is divided into 3 manifestation subscales (i.e. abdominal, rectal, and stool). Items are scored on a 4-point Likert scale, with a score of 4 demonstrating the worst symptom severity 18, 19.
- The Patient Assessment of Constipation Quality of Life (PAC-QOL) is a comprehensive measure of the constipation burden on the patient's quality of life (QoL) in terms of functions, activities, and well-being. It is considered a valid and reproducible tool with high internal consistency 20.
- The Short Form-36 (SF-36) is well validated, reliable, does not require more time or effort to be completed, and has been presented in several international studies 21- 23. It is a 36-item questionnaire that measures the QoL across 8 scales (domains), which are based on both physical and emotional aspects. The 8 domains of SF36 are concerned with the following: physical functioning, role limitations owing to physical health or emotional problems, energy/fatigue, emotional wellbeing, social functioning, pain, and general health. In addition, a single item is included to identify any perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. The scores of the SF-36TM physical component summary and SF-36TM mental component summary are calculated by simply calculating the mean score of all of the physically and emotionally relevant items 23- 25.
Descriptive statistics were calculated as the mean and standard deviation. Inferential statistics evaluated the changes in constipation symptoms, QoL questionnaires, and BMI using unpaired t-test between the 2 groups, while paired t-test was used to measure the changes within a group. Pearson correlation coefficient was used to measure the strength and direction of the relationship between BMI and PAC-SYM scores, and between BMI and QoL. All data were analyzed using SPSS version 18.0 (SPSS, Chicago, IL, USA), with statistical significance set at p ≤ 0.05.
- Conditions
- Constipation - Functional
- Being tested
- Group A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Group A Physical activity and low caloric diet for
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Physical activity, a low caloric diet, and the routine standard care for constipation Receives: Other: Group A |
| Group B | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity and constipation relationship
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study startDec 2015
- Primary completionSep 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahlia University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Dr Sayed Tantawy, Ahlia University
- Investigators
- Sayed A Tantawy, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106857
- Sponsor's protocol ID
- P.T. REC/012/001535
- Acronym
- constipation
- Status last verified
- Apr 2017
- First submitted
- 28 Mar 2017
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: publication
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proposed Physical Activity and Diet Control to Manage Constipation in Middle Age Obese Women
- ClinicalTrials.gov ID
- NCT03106857
- Acronym / sponsor ID
- constipation / P.T. REC/012/001535
- Conditions
- Constipation - Functional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Ahlia UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In total, 125 women aged between 20 and 40 years were recruited in this study. Participants were considered eligible when they met the inclusion criteria of being diagnosed with functional constipation, as defined by the Rome Foundation. The study was a randomized controlled trial carried out at Cairo University Hospital.Patients whose BMI exceeded 30 kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation.
Detailed description
In total, 125 women aged between 20 and 40 years were recruited in this study. Participants were considered eligible when they met the inclusion criteria of being diagnosed with functional constipation, as defined by the Rome Foundation. The study was a randomized controlled trial carried out at Cairo University Hospital.
Patients whose BMI exceeded 30 kg/m2 were included. In addition, they fulfilled the ROM criteria of constipation, as follows: (1) Suffered from any 2 or more of the following symptoms in the past 12 weeks (not necessarily consecutive), with the onset of symptoms at least 6 months prior to diagnosis: a) straining during at least 25% of defecations, b) lumpy or hard stools in at least 25% of defecations, c) sensation of incomplete evacuation for at least 25% of defecations, d) sensation of anorectal obstruction/blockage for at least 25% of defecations, e) requirement of manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor muscles), and f) fewer than 3 defecations per week; (2) Loose stools rarely occurred without the use of laxatives; (3) Insufficient criteria for irritable bowel syndrome; and (4) Women were sedentary (less than 1 hour/week of physical activity), with no evidence of participation in diet control/weight reduction programs within the last 6 months.
Patients with metabolic, endocrine, and neurologic constipation; current or past smokers; those with any orthopedic limitation; and those with congenital megacolon, pseudo-obstruction, and anorectal disorders were excluded from the study. Patients suffering from constipation due to drugs, disabled patients, and those who had undergone any abdominal surgery during the intervention or those who failed to complete the study protocol were also excluded. All participants provided a written informed consent before enrolling in the study.
Study design and intervention:
Participants were randomly divided into 2 groups. Group A included 62 women who were following a suggested protocol of physical activity and a low caloric diet in addition to the routine standard care for constipation. The low caloric diet allowed 1000-1200 kcal/day, divided as follows: 50%-60% carbohydrates, 20% protein, <30% total fat, and 18 g of fiber /1000 Kcal. The diet plans were revised every 2 weeks and the diet was modified while ensuring that it was within the allowed caloric value, in addition to the routine standard care for constipation. Group B included 63 patients who received only the standard medical care for constipation and a low caloric diet as in Group A. Patients in both groups followed their program for 12 weeks.
Exercise intervention for Group (A) Each woman in Group A participated in the exercise training program for 12 weeks, 3 times per week, with each exercise session lasting for 60 minutes. The participants were instructed not to eat for 3 hours before the exercise session.
The exercise training program was in the form of walking on a treadmill without tightly grasping the rails, because this action seemed to reduce the workload during any stage of the exercise. To overcome this issue, the participants were asked to remove their hands from the rails, close their fists, and place only 1 finger on the rails to maintain balance once they were accustomed to walking on the treadmill.
The exercise session was started by a 10-minute warm-up, which involved walking without any resistance or inclination on the walkway of the treadmill, followed by 40 minutes of walking with 15 degrees of inclination and a speed adjusted to reach 20%-40% of the target heart rate (THR) in the first 6 weeks of the study; the speed was increased to reach 40%-60% THR in the next 6 weeks of the study. The session ended by 10 minutes of recovery period, in which the intensity of the exercise was reduced to the level of the warm-up.
The assessment procedures performed before and after 12 weeks of intervention consisted of the following:
- The Patient Assessment of Constipation - Symptom (PAC-SYM) is a reliable and valid 16, 17 tool to measure the patient's perspective of constipation symptoms in terms of the frequency and severity. It is a 12-item self-reported measure, which is divided into 3 manifestation subscales (i.e. abdominal, rectal, and stool). Items are scored on a 4-point Likert scale, with a score of 4 demonstrating the worst symptom severity 18, 19.
- The Patient Assessment of Constipation Quality of Life (PAC-QOL) is a comprehensive measure of the constipation burden on the patient's quality of life (QoL) in terms of functions, activities, and well-being. It is considered a valid and reproducible tool with high internal consistency 20.
- The Short Form-36 (SF-36) is well validated, reliable, does not require more time or effort to be completed, and has been presented in several international studies 21- 23. It is a 36-item questionnaire that measures the QoL across 8 scales (domains), which are based on both physical and emotional aspects. The 8 domains of SF36 are concerned with the following: physical functioning, role limitations owing to physical health or emotional problems, energy/fatigue, emotional wellbeing, social functioning, pain, and general health. In addition, a single item is included to identify any perceived change in health, making the SF-36 a useful indicator for change in QoL over time and treatment. The scores of the SF-36TM physical component summary and SF-36TM mental component summary are calculated by simply calculating the mean score of all of the physically and emotionally relevant items 23- 25.
Descriptive statistics were calculated as the mean and standard deviation. Inferential statistics evaluated the changes in constipation symptoms, QoL questionnaires, and BMI using unpaired t-test between the 2 groups, while paired t-test was used to measure the changes within a group. Pearson correlation coefficient was used to measure the strength and direction of the relationship between BMI and PAC-SYM scores, and between BMI and QoL. All data were analyzed using SPSS version 18.0 (SPSS, Chicago, IL, USA), with statistical significance set at p ≤ 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Other: Group APhysical activity, a low caloric diet, and the routine standard care for constipation |
| Group B | No intervention | –No intervention |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients whose BMI exceeded 30 kg/m2 were included.
- Suffered from any 2 or more of the following symptoms in the past 12 weeks (not necessarily consecutive), with the onset of symptoms at least 6 months prior to diagnosis:
- Loose stools rarely occurred without the use of laxatives;
- Insufficient criteria for irritable bowel syndrome; and
- Women were sedentary (less than 1 hour/week of physical activity), with no evidence of participation in diet control/weight reduction programs within the last 6 months.
Key exclusion criteria (5 listed)
- Patients with metabolic, endocrine, and neurologic constipation;
- current or past smokers;
- those with any orthopedic limitation; and
- those with congenital megacolon, pseudo-obstruction, and anorectal disorders were excluded from the study.
- Patients suffering from constipation due to drugs, disabled patients, and those who had undergone any abdominal surgery during the intervention or those who failed to complete the study protocol were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AGroup A Physical activity and low caloric diet for | Other | Group A |
Primary outcome
Physical activity and constipation relationship
Time frame: 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Individual participant dataSharing planned: Yes. publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sayed A Tantawy, PhD study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A in people with Constipation - Functional, run by Ahlia University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity and constipation relationship (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.