Protocol summary

Study aim
To determination the effect of a targeted core muscle specific exercise program on decreasing of gastrointestinal symptoms in females with functional abdominal bloating.
Design
Single-blind with two arm parallel group randomized trial. The categorized method of participants into intervention (n=20) and control (n=20) groups is blocking 4 pieces in 1:1 ratio.
Settings and conduct
The study will be conducted in the Gastroenterology Health Center of Isfahan University of Medical Sciences. Each participant will be assessed by a gastroenterologist for confirmation of the presence of functional abdominal bloating and distension. Then they will be randomly divided into intervention (n=20) and control (n=20) groups. All outcomes will be assessed by one examiner before and after 6 weeks. This examiner will be blinded to grouping of the participants.
Participants/Inclusion and exclusion criteria
18-60 years old females living in Isfahan city that functional abdominal bloating and distension of them will be confirmed based on Rome IV. However, females with other functional gastrointestinal disorders will not be included.
Intervention groups
Intervention group will have 3 exercise periods (each will be 2 weeks) of diaphragmatic breathing exercise, bridge with balloon and ball exercise and expiratory apnea respectively. Each period will be done as 3 sessions per week under supervision of therapist. The control group during this time should follow dietary-medication patterns prescribed by the specialist and avoid participation in any regular sport activity.
Main outcome variables
Abdominal girth, bloating severity and abdominal distension severity before and after of standard meal load The strength of muscles of anterior wall of abdomen

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240322061351N1
Registration date: 2024-04-02, 1403/01/14
Registration timing: prospective

Last update: 2024-04-02, 1403/01/14
Update count: 0
Registration date
2024-04-02, 1403/01/14
Registrant information
Name
Tayebeh Roghani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5040
Email address
t.roghani@rehab.mui.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of a Targeted Core Muscle Specific Exercise Program on Gastrointestinal Symptoms in Young and Middle-aged Females with Functional Abdominal Bloating : A Randomized Controlled Trial
Public title
The Effect of a Core Muscle Exercise Program on Gastrointestinal Symptoms in Females with Functional Abdominal Bloating
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index less than 30 kg/m2 The gastroenterologist approves the entry of participants into the exercise program The presence of visible abdominal distension episodes (with the lack of non-functional disorders confirmation) and participant feels well in between these episodes The ability of correct diaphragmatic breathing according to intended instruction without pain
Exclusion criteria:
Functional abdominal bloating without visible abdominal distension Unremitting distension Any kind of gastrointestinal system surgery The history of any kind of surgery of stomach, different region of trunk, pelvis and lower limbs in past year spinal deformities such as scoliosis and hyperkyphotic posture The diagnosis of other functional gastrointestinal disorders (FGIDs) The confirmation of non-functional causes History of current back pain or back pain requiring medical attention in past year Neurological disorders, Pulmonary disorders, rheumatology conditions, cardiovascular diseases, malignancy or chemotherapy The history of the vertebral column or chest fracture Use of medications equal or over 3 moths during prior 12 months that could affect muscle performance Use of various antibiotics, bismuth, probiotic drugs during the last three months current use of Mebeverine, Dimethicone, Dicyclomine, Hyoscine, Belladonna Using special diets, such as ketogenic diet, vegetarianism, Fermentable, Oligosacharides, Disacharides, Monosacharides AND Polyols (FODMAP) Smoking and alcohol consumption Current pregnancy or lactating Allergy to egg consumption Difficulty in understanding of therapist's instruction (having a minimum education level of diploma) Participating in sports activities regularly at least one year before the start of the study (frequency of 3 days of week and at least 30 min in day) Hiatus hernia
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
According to resulting sample size, one random sample (trough blocking 4 pieces) for interventional group (n=20) and one random sample trough the same method for control group (n=20) in 1:1 ratio will be selected. The selection of participants will be performed by one third person who is not involved in the treatment and measurements.
Blinding (investigator's opinion)
Single blinded
Blinding description
It is not possibility of blindness of participants. But examiner (will be same main researcher) will be different from therapist, so our study will be single-blind.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of the "Alzahra Research Centers"
Street address
Research Ethics Committee, Alzahra Research Centers, Sofe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Approval date
2024-03-17, 1402/12/27
Ethics committee reference number
IR.ARI.MUI.REC.1402.350

Health conditions studied

1

Description of health condition studied
Functional abdominal bloating
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The effect of core muscle exercise program on abdominal girth before and after one standard meal load
Timepoint
The effect of core muscle exercise program on abdominal girth (before and after one standard meal load) will be assessed before and after 6 weeks of study
Method of measurement
One mounted tape on one non-elastic belt will be placed on the navel of participant in sitting position and the number of tape will be read in millimeter. This measurement will be performed during 3 consecutive respiratory cycles and mean will be recorded as millimeter

2

Description
The effect of core muscle exercise program on bloating severity before and after one standard meal load
Timepoint
The effect of core muscle exercise program on bloating severity (before and after one standard meal load) will be assessed before and after 6 weeks of study
Method of measurement
Self report of the bloating severity will be recorded using a non-likert scale (0-4: 0:never, 1: mild sensation, 2: clear sensation, 3: unpleasant sensation and 4: unbearable or painful sensation) before and after the meal load. The procedure will be repeated 3 times and the mean of them will be recorded.

3

Description
The effect of core muscle exercise program on bloating severity before and after one standard meal load
Timepoint
The effect of core muscle exercise program on distension severity (before and after one standard meal load) will be assessed before and after 6 weeks of study
Method of measurement
Self report of the distension severity will be recorded using a graphic rating scale (0: no distension - 6: very sever distension) before and after the meal load. The procedure will be repeated 3 times and the mean of them will be recorded.

4

Description
The effect of core muscle exercise program on strength of anterior abdominal wall muscles
Timepoint
The effect of core muscle exercise program on strength of anterior abdominal wall muscles will be assessed before and after 6 weeks of study
Method of measurement
After 5 minutes a warm-up, the participants will be instructed to sit on the stool in neutral upright position back to load cell with the hips and knees flexed to 90 degree, and arms crossed over the chest. Thigh and Anterior Superior iliac Spine (ASIS) restraints will be secured to the legs and back support of the stool respectively. The load cell will be aligned with the scapula and the participants will be connected to the load cell through four inflexible ropes of the vest.. The participants should pull their trunk forward maximally and maintain this maximum force for three-five seconds. Participant should repeat 3 times.The maximum force will be documented as anterior abdominal muscle strength (kg).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: During the 6 weeks of intervention, participants should follow dietary-medication patterns prescribed by the specialist and avoid participation in any regular sport activity. In this group,there will be 3 exercise periods (each will be 2 weeks) of diaphragmatic breathing exercise in hooklying position (first 2 week: 3 sessions of 40 minutes per week under supervision of therapist), bridge with balloon and ball exercise (second 2 week: balloon blowing exercise in the bridge position associated with a ball between knees, this exercise will be performed as 3 sessions of 25 minutes per week under supervision of therapist) and expiratory apnea (third 2 week: in the each positions of hooklying and bridge with balloon and ball, participant should perform apnea 4 seconds following of diaphragmatic breathing exercise. This exercise will be done as 3 sessions of 35 minutes per week under supervision of therapist) respectively. During all 6 weeks, the intervention group should perform diaphragmatic breathing exercise daily and 30 minutes after each meal. The control of this case is done by the therapist with the request to complete a notebook and its control is done on the days of the visit.
Category
Rehabilitation

2

Description
Control group: This group during the 6 weeks should follow dietary-medication patterns prescribed by the specialist and avoid participation in any regular sport activity.These Participants will be monitored weekly by the therapist's phone call to avoid any changes in diet-medicine or regular exercise.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology and Liver Research Center of Isfahan University of Medical Sciences
Full name of responsible person
Tayebeh Roghani
Street address
Gastroenterology and Liver Research, Health Building, Entrance door of Al-Zahra Hospital (S) staff, Sefe Blvd., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3822 2675
Email
t.roghani@rehab.mui.ac.ir

2

Recruitment center
Name of recruitment center
Gastroenterology Clinic of Khorshid Educational Medical Hospital
Full name of responsible person
Tayebeh Roghani
Street address
Gastroenterology Clinic, Khorshid Educational Medical Hospital, Ostandari Ave, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81458-31451
Phone
+98 31 3222 2127
Email
t.roghani@rehab.mui.ac.ir

3

Recruitment center
Name of recruitment center
Private Clinic of DR. Peyman Adibi
Full name of responsible person
Tayebeh Roghani
Street address
Private Clinic of Dr. Peyman Adibi, Across from Shariati Hospital, Shariati Ave, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3627 8361
Email
t.roghani@rehab.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Vice-Chancellery for Research and Technology, Hezar Jerib street, Isfahan, Iran.Bldg No. 4, Isfahan University of Medical Sciences and Health Services,
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@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
Tayebeh Roghani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Rehabilitation Sciences, Isfahan Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5040
Email
t.roghani@rehab.mui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tayebeh Roghani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5040
Email
t.roghani@rehab.mui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tayebeh Roghani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Rehabilitation Sciences, Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5040
Email
t.roghani@rehab.mui.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data of primary outcomes after statistical analysis will be shared as a original article.
When the data will become available and for how long
Start access will be from 2025
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers who are conducting a meta-analysis study.
From where data/document is obtainable
Dr. Tayebeh Roghani 00983137925040 t.roghani@rehab.mui.ac.ir tayebeh.roghaniGmail.com
What processes are involved for a request to access data/document
After receiving the request, depending on the type of request and the type of file in question, the documents will be emailed to them for about a week.
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