Investigating the effect of non-pharmacological treatment including diet adjustment and increased physical activity in the treatment of functional constipation
Investigating the effect of non-pharmacological treatment (diet adjustment and increased physical activity) in the treatment of functional constipation
Design
Clinical trial without control group (single group), phase 2 on 64 patients.
Settings and conduct
The present study is a clinical trial that will be conducted in Isfahan. Patients' demographic information is first collected by a questionnaire. The severity of constipation in patients at the beginning of the study is measured by a questionnaire based on the Rome III criteria. Patients will then be scheduled to adjust their diet and increase physical activity for 12 weeks.
Again, the constipation questionnaires for all patients will be filled in weeks 2, 4, 8, and 12 after the intervention begins, and scoring will be done.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having functional constipation based on Rome III criteria;
Providing informed written consent to participate in the study.
Non-inclusion criteria:
Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract;
Any serious physical illness or illnesses such as inflammation or malignancy;
Any physical problem that prevents from doing physical activity;
Addiction to the drug or sleeping pills;
History of chronic diseases such as diabetes.
Intervention groups
Patients will be scheduled to adjust their diet and increase physical activity for 12 weeks. Diet adjustment is done by designing a diet containing 3 to 6 grams of fiber and 2 glasses of water or other liquids other than tea on a daily basis and by a nutritionist, as well as according to the daily needs of each person. Activity levels are defined as half an hour of brisk walking daily, which increases heart rate by 50%.
Main outcome variables
Constipation severity score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200601047621N2
Registration date:2020-06-23, 1399/04/03
Registration timing:prospective
Last update:2020-06-23, 1399/04/03
Update count:0
Registration date
2020-06-23, 1399/04/03
Registrant information
Name
Maryam Soheilipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3729 4502
Email address
maryamsoheilip@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-25, 1399/06/04
Expected recruitment end date
2020-10-24, 1399/08/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of non-pharmacological treatment including diet adjustment and increased physical activity in the treatment of functional constipation
Public title
Non-pharmacological treatment of constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having functional constipation based on Rome III criteria
Free and informed written consent to participate in the study
Exclusion criteria:
Any history of chronic inflammatory disease or structural disease of the gastrointestinal tract
Any serious physical problems or illness such as inflammation or malignancy
Any physical problem that prevents from doing physical activity
Drug or sleeping pills addiction
History of chronic diseases such as diabetes
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
6719674255
Approval date
2020-05-23, 1399/03/03
Ethics committee reference number
IR.MUI.MED.REC.1399.106
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
Functional constipation
Timepoint
Weeks 2, 4, 8 and 12 after the intervention begins
Method of measurement
Questionnaire for constipation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The severity of constipation in patients at the beginning of the study is measured by a questionnaire based on Rome III criteria, then patients will be scheduled to adjust their diet and increase physical activity for 12 weeks. Diet adjustment is done by designing a diet containing 3 to 6 grams of fiber and 2 glasses of water or other liquids other than tea on a daily basis and by a nutritionist, as well as according to the daily needs of each person. The rate of activity is defined as half an hour of brisk walking daily, which increases the heart rate by 50%. Again, constipation severity questionnaire will be filled out for all patients at weeks 2, 4, 8, and 12 after the intervention begins.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid Hospital
Full name of responsible person
Maryam Soheilipour
Street address
Khorshid hospital, Ostandari Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
6719674255
Phone
+98 31 3729 4225
Email
maryamsoheilip@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
6719674255
Phone
+98 31 3729 4079
Email
haghjoo.sh@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Soheilipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
6719674255
Phone
+98 31 3729 4225
Email
maryamsoheilip@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Soheilipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
6719674255
Phone
+98 31 3729 4225
Email
maryamsoheilip@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Soheilipour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No. 8, Hezar Jarib Ave., Daneshgh Blvd., Isfahan
City
Isfahan
Province
Isfehan
Postal code
6719674255
Phone
+98 31 3729 4225
Email
maryamsoheilip@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information of this research will be available after deleting the names and details of the patients, through the research deputy of Isfahan University of Medical Sciences. These data include age, sex, duration of illness, and treatment information.
When the data will become available and for how long
Late 2020
To whom data/document is available
Health researchers
Under which criteria data/document could be used
In order to use the information in future research and under the permission of the Vice Chancellor for Research
From where data/document is obtainable
Information will be available through the Research Vice Chancellor of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Apply online through the university website and issue a license within about 2 weeks and apply for data access