- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06783894
Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome
January 15, 2025 updated by: Ali Mohamed Ali ismail, Cairo University
psychological disturbances resulting from irritable bowel syndrome causes sexual dysfunction in men such as weak erection of penis.
The different exercise forms are important in improving symptoms of this syndrome and exercise also may improve sexual dysfunction in men
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Forty irritable bowel syndrome men with sexual dysfunction ( weak erection of penis or erectile dysfunction) will divided into Group I or Group II .
The group will contain twenty subjects.
Group I will perform ellpitical physical activity (40 minutes on elliptical trainer three times weekly.
the duration of physical activity will be 12 weeks.
Group II will not perform any physical activity.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ali MA Isamil, Lecturer
- Phone Number: 0201005154209
- Email: ali.mohamed@pt.cu.edu.eg
Study Locations
-
-
Giza
-
Dokki, Giza, Egypt
- Recruiting
- Faculty of Physical Therapy Cairo University
-
Contact:
- Ali Ismail, lecturer
- Phone Number: +201005154209
- Email: ali.mohamed@pt.cu.edu.eg
-
Principal Investigator:
- Ali MA Ismail, Lecturer
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- men with irritable bowel syndrome
- men with erectile dysfunction
- married men
Exclusion Criteria:
- obese men
- chest/renal disease men
- cardiac/metabolic disease men
- systemic disease men
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: group I
twenty irritable bowel syndrome men with sexual dysfunction ( weak erection of penis or erectile dysfunction) will perform ellpitical physical activity (40 minutes on elliptical trainer three times weekly.
the duration of physical activity will be 12 weeks.
|
twenty irritable bowel syndrome men with sexual dysfunction ( weak erection of penis or erectile dysfunction) will perform ellpitical physical activity (40 minutes on elliptical trainer three times weekly.
the duration of physical activity will be 12 weeks.
|
|
No Intervention: Group II
twenty irritable bowel syndrome men with sexual dysfunction (weak erection of penis or erectile dysfunction) will perform no type of activity (wait list group).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
international index of erectile fucntion
Time Frame: it will be assessed after 12 weeks
|
it is questionnaire that contains five questions assessing erectile functions
|
it will be assessed after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Irritable Bowel Syndrome Severity Scoring System
Time Frame: it will be assessed after 12 weeks
|
it is a questionnaire that assesses the severity symptoms related to irritable bowel syndrome
|
it will be assessed after 12 weeks
|
|
Irritable Bowel Syndrome Quality of Life Questionnaire
Time Frame: it will be assessed after 12 weeks
|
it is a questionnaire that assesses the quality of life in patients irritable bowel syndrome
|
it will be assessed after 12 weeks
|
|
State Anxiety Inventory
Time Frame: it will be assessed after 12 weeks
|
it is a questionnaire that assesses the long standing anxiety
|
it will be assessed after 12 weeks
|
|
Beck depression inventory
Time Frame: it will be assessed after 12 weeks
|
it is a questionnaire that assesses depression symptoms
|
it will be assessed after 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali MA Ismail, Cairo university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2025
Primary Completion (Estimated)
May 30, 2025
Study Completion (Estimated)
June 2, 2025
Study Registration Dates
First Submitted
January 15, 2025
First Submitted That Met QC Criteria
January 15, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 15, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Pathologic Processes
- Genital Diseases, Male
- Male Urogenital Diseases
- Intestinal Diseases
- Disease
- Digestive System Diseases
- Gastrointestinal Diseases
- Colonic Diseases
- Colonic Diseases, Functional
- Sexual Dysfunction, Physiological
- Sexual Dysfunctions, Psychological
- Irritable Bowel Syndrome
- Syndrome
- Erectile Dysfunction
Other Study ID Numbers
- IRB00014233-20
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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