NCT06783894

Brief 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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 20, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2025

Completed
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

5 months

First QC Date

January 15, 2025

Last Update Submit

January 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • international index of erectile fucntion

    it is questionnaire that contains five questions assessing erectile functions

    it will be assessed after 12 weeks

Secondary Outcomes (4)

  • Irritable Bowel Syndrome Severity Scoring System

    it will be assessed after 12 weeks

  • Irritable Bowel Syndrome Quality of Life Questionnaire

    it will be assessed after 12 weeks

  • State Anxiety Inventory

    it will be assessed after 12 weeks

  • Beck depression inventory

    it will be assessed after 12 weeks

Study Arms (2)

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.

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).

Interventions

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 I

Eligibility Criteria

Age30 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • men with irritable bowel syndrome
  • men with erectile dysfunction
  • married men

You may not qualify if:

  • obese men
  • chest/renal disease men
  • cardiac/metabolic disease men
  • systemic disease men

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Dokki, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Irritable Bowel SyndromeErectile Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali MA Ismail

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali MA Isamil, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy

Study Record Dates

First Submitted

January 15, 2025

First Posted

January 20, 2025

Study Start

January 12, 2025

Primary Completion

May 30, 2025

Study Completion

June 2, 2025

Last Updated

January 20, 2025

Record last verified: 2025-01

Locations