NCT06716125

Brief Summary

obese male usually complain subjective tinnitus that may affect their sexual function.

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 obesity

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable obesity

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

November 6, 2024

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 6, 2025

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

5 months

First QC Date

November 28, 2024

Last Update Submit

November 28, 2024

Conditions

ObesityTinnitus, SubjectiveErectile Dysfunction

Outcome Measures

Primary Outcomes (1)

  • international index of erectile function

    Arabic form that contain five question will be used

    it will be assessed after 12 weeks

Secondary Outcomes (8)

  • body mass index

    it will be assessed after 12 weeks

  • waist circumference

    it will be assessed after 12 weeks

  • visual analogue scale of severity of tinnitus

    it will be assessed after 12 weeks

  • visual analogue scale of discomfort induced by tinnitus

    it will be assessed after 12 weeks

  • tinnitus handicap inventory

    it will be assessed after 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

group I

EXPERIMENTAL

This group (n =20 for the group) will administer low calorie diet for 12 weeks plus additionally administering supervised walking training aerobic training for 45 minutes 3 times per week for 12 weeks.

Behavioral: aerobic treadmill walking plus low calorie diet

Group II

ACTIVE COMPARATOR

this group (n =20 for the group) will administer low calorie diet for 12 weeks

Behavioral: low calorie diet

Interventions

aerobic treadmill walking plus low calorie dietBEHAVIORAL

this group (n =20 for the group) will administer low calorie diet for 12 weeks plus additionally administering supervised walking treadmill aerobic training for 45 minutes 3 times per week for 12 weeks).

group I
low calorie dietBEHAVIORAL

this group (n =20 for the group) will administer low calorie diet for 12 weeks

Group II

Eligibility Criteria

Age35 Years - 45 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsbased on self-representation of gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • obese person
  • body mass index less than 40 kg/m2 and more than 30 kg/m2
  • males with subjective tinnitus (bilateral presentation from at least 24 weeks).
  • males with sexual dysfunction (erectile dysfunction from at least 24 weeks)

You may not qualify if:

  • cardiac diseased males
  • respiratory diseased males
  • hepatic, musculoskeletal, and hepatic diseased males
  • diabetic males

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy Cairo university

Dokki, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

ObesityTinnitusErectile Dysfunction

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsEnergy IntakeDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Isamil, Lecturer

CONTACT

0201005154209ali.mohamed@pt.cu.edu.eg

ahmed elfahl, Lecturer

CONTACT

0201001891218ahmed.elfahl@buc.edu.eg

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

November 28, 2024

First Posted

December 4, 2024

Study Start

November 6, 2024

Primary Completion

April 6, 2025

Study Completion

April 6, 2025

Last Updated

December 4, 2024

Record last verified: 2024-11

Locations

EG(1)