Lifestyle Changes in Obese Males With Sexual Dysfunction and Tinnitus
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age35-45
SponsorCairo University
About this trial
obese male usually complain subjective tinnitus that may affect their sexual function.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
cardiac diseased males
respiratory diseased males
hepatic, musculoskeletal, and hepatic diseased males
diabetic males
Trial design
Design model
Parallel
Treatments tested in this trial
aerobic treadmill walking plus low calorie diet
Behavioralthis 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).
low calorie diet
Behavioralthis group (n =20 for the group) will administer low calorie diet for 12 weeks
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: group IExperimental treatment 1 intervention
Group B: Group IIActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
international index of erectile function
Arabic form that contain five question will be used
Time frame
it will be assessed after 12 weeksSecondary outcomes
1
body mass index
it will be assessed at empty stomach and bladder
Time frame
it will be assessed after 12 weeks2
waist circumference
it will be assessed at level of umbilicus
Time frame
it will be assessed after 12 weeks3
visual analogue scale of severity of tinnitus
it will be 10-cm line that will be used to assess tinnitus severity
Time frame
it will be assessed after 12 weeks4
visual analogue scale of discomfort induced by tinnitus
it will be 10-cm line that will be used to assess discomfort induced by tinnitus
Time frame
it will be assessed after 12 weeksSponsors and contacts
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Source ClinicalTrials.gov