Irritable Bowel SyndromeNCT06783894
Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome
A study testing exercise (elliptical training) in people with Irritable Bowel Syndrome and Erectile Dysfunction, run by Cairo University at 1 site in Egypt.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 30 to 50 years, men only
- Conditions the study is for
- Irritable Bowel Syndrome, Erectile Dysfunction
- What is being tested?
- exercise (elliptical training)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jan 2025to 2 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- men with irritable bowel syndrome
- men with erectile dysfunction
- married men
Who cannot join
- obese men
- chest/renal disease men
- cardiac/metabolic disease men
- systemic disease men
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
faculty of physical therapy Cairo university
Dokki, Giza Governorate
Ali Ismail, lecturer, +201005154209, ali.mohamed@pt.cu.edu.eg
Ali MA Ismail, Lecturer
About this study
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
Read the 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.
- Conditions
- Irritable Bowel Syndrome, Erectile Dysfunction
- Being tested
- exercise (elliptical training)
- Medical subject headings
- Irritable Bowel Syndrome, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise (elliptical training)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| group I | Experimental | 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. Receives: Behavioral: exercise (elliptical training) |
| Group II | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
international index of erectile fucntion
it is questionnaire that contains five questions assessing erectile functions
Measured: it will be assessed after 12 weeks
Secondary outcomes (4)
Irritable Bowel Syndrome Severity Scoring System
it is a questionnaire that assesses the severity symptoms related to irritable bowel syndrome
Measured: it will be assessed after 12 weeks
Irritable Bowel Syndrome Quality of Life Questionnaire
it is a questionnaire that assesses the quality of life in patients irritable bowel syndrome
Measured: it will be assessed after 12 weeks
State Anxiety Inventory
it is a questionnaire that assesses the long standing anxiety
Measured: it will be assessed after 12 weeks
Beck depression inventory
it is a questionnaire that assesses depression symptoms
Measured: it will be assessed after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start12 Jan 2025
- Primary completion30 May 2025 (estimated)
- Study completion2 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783894
- Sponsor's protocol ID
- IRB00014233-20
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elliptical Physical Activity and Sexual Dysfunction in Males With Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT06783894
- Acronym / sponsor ID
- IRB00014233-20
- Conditions
- Irritable Bowel Syndrome, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 2 Jun 2025 (estimated)
- First posted
- 20 Jan 2025 (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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group I | Experimental | Behavioral: exercise (elliptical training)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. |
| Group II | No intervention | –twenty irritable bowel syndrome men with sexual dysfunction (weak erection of penis or erectile dysfunction) will perform no type of activity (wait list group). |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- men with irritable bowel syndrome
- men with erectile dysfunction
- married men
Key exclusion criteria (4 listed)
- obese men
- chest/renal disease men
- cardiac/metabolic disease men
- systemic disease men
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 |
|---|---|---|
| exercise (elliptical training)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. | Behavioural | group I |
Primary outcome
international index of erectile fucntion
Time frame: it will be assessed after 12 weeks
it is questionnaire that contains five questions assessing erectile functions
4 secondary outcomes
Irritable Bowel Syndrome Severity Scoring System
Time frame: it will be assessed after 12 weeks
Irritable Bowel Syndrome Quality of Life Questionnaire
Time frame: it will be assessed after 12 weeks
State Anxiety Inventory
Time frame: it will be assessed after 12 weeks
Beck depression inventory
Time frame: it will be assessed after 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
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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.
Ali MA Ismail principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise (elliptical training) in people with Irritable Bowel Syndrome and Erectile Dysfunction, run by Cairo University at 1 site 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Isamil, Lecturer (0201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
international index of erectile fucntion (time frame: it will be assessed after 12 weeks). 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 20 Jan 2025.