Evaluating the effects of aerobic exercise with treadmill on severity of symptoms and quality of life in female with irritable bowel syndrome with mild and moderate severity of symptoms and to compare it with female with daily usual activities
It is a randomized controlled trial study that evaluate the effects of aerobic exercise with treadmill on severity of symptoms and quality of life of female with irritable bowel syndrome with mild and moderate severity of symptoms. 20 females with irritable bowel syndrome in 18-65 years old with mild and moderate severity of symptoms will enter to study. These patients will assigned to treadmill and control group. Before starting the study both of groups will fill the quality of life and severity of symptoms questionnaires. Treadmill group will exercise on treadmill 3 times a week for 6 weeks for 30 minutes. Control group will continue to same usual daily activities. At the end, the severity of symptoms and quality of life of both groups will be assessed with severity of symptoms and quality of life questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031927287N2
Registration date:2017-04-12, 1396/01/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
Javid Mostamand
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3089
Email address
mostamand@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2017-03-20, 1395/12/30
Expected recruitment end date
2017-06-22, 1396/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of aerobic exercise with treadmill on severity of symptoms and quality of life in female with irritable bowel syndrome with mild and moderate severity of symptoms and to compare it with female with daily usual activities
Public title
evaluating the effects of aerobic exercise on severity of symptoms and quality of life on female with irritable bowel syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. female with irritable bowel syndrome with mild and moderate severity of symptoms; 2. stable baseline blood pressure; 3. patients that are able to increase physical activity; 4. patients in 18-65 years old; 5. without cardiovascular problems.
Exclusion criteria: 1. female with regular exercise program; 2. history of rheumatological diseases in lower extremity; 3. use of external device for walking; 4. history of metabolic disease, neuorologic disorders, cardiovascular problems, respiratory and renal pulmonary problems that is obstructive in participation for aerobic exercise; 5. history of knee injury or surgery of knee in past recent year; 6. history of arthroplasty in joints of lower extremity; 7. history of lower extremity fracture in past 6 months; 8. evidence of clinical osteoarthritis in hip, knee, ankle and foot; 9. major vision disorders; 10. musculo skeletal, hereditary or acquired disorders in lower extremity; 11. usage of drugs that affect on metabolism or balance; 12. pregnancy; 13. organic gastrointestinal disorders.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Postal code
8174673461
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MUI.REC.1395.3.528
Health conditions studied
1
Description of health condition studied
Irritable bowel syndrome
ICD-10 code
K58
ICD-10 code description
Irritable bowel syndrome
Primary outcomes
1
Description
Severity of symptoms
Timepoint
Before and 6 weeks after intervention
Method of measurement
irritable bowel syndrome severity scoring system Questionnaire
2
Description
Irritable bowel syndrome quality of life
Timepoint
Before and 6 weeks after intervention
Method of measurement
irritable bowel syndrome quality of life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Treadmill group: walking on tredmill with controlled speed in oreder to achieving goal heart rate for 30 minutes 3 times aweek for 6 weeks
Category
Rehabilitation
2
Description
Control group: continue to same previous usual daily activities and not doing exercise activities.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculo-skeletal Disorders Researche Center
Full name of responsible person
Mozhgan Fani
Street address
Isfahan University of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chacellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Zahra Sadat Rezaeian
Street address
Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chacellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mozhgan Fani
Position
Bachelors degree
Other areas of specialty/work
Street address
Musculo skeletal Disorders Research Center, Isfahan University of Medical Sciences