Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes in Men With Psoriasis

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05632042

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

complaint of sexual dysfunction and metabolic syndrome are highly reported in men with psoriasis

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Metabolic Syndrome Erectile Dysfunction	Behavioral: lifestyle modification (exercise and control of diet)	N/A

Detailed Description

erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 60) will assigned to study group (group = 30 patients) that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week) or control group (group=30 patients) that will receive no lifestyle changes/modifications.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes/Modifications in Men With Psoriasis

Actual Study Start Date :

Oct 16, 2022

Anticipated Primary Completion Date :

Apr 16, 2023

Anticipated Study Completion Date :

Apr 16, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: lifestyle-modification group erectile dysfunction (ED) psoriatic men with metabolic syndrome (group = 30 patients) will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week)	Behavioral: lifestyle modification (exercise and control of diet) erectile dysfunction (ED) psoriatic men with metabolic syndrome that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week)
No Intervention: control group erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 30) that will receive no lifestyle changes/modifications.

Arm

Intervention/Treatment

Experimental: lifestyle-modification group

erectile dysfunction (ED) psoriatic men with metabolic syndrome (group = 30 patients) will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week)

Behavioral: lifestyle modification (exercise and control of diet)

erectile dysfunction (ED) psoriatic men with metabolic syndrome that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week)

No Intervention: control group

erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 30) that will receive no lifestyle changes/modifications.

Outcome Measures

Primary Outcome Measures

International Index of Erectile Function [It will be measured after 12-week intervention]
Arabic version of this 5-item questionnaire will used to assess erectile function/dysfunction

Secondary Outcome Measures

psoriasis area and severity index [It will be measured after 12-week intervention]
it is a tool used to measure the severity and extent of psoriasis.
body mass index [It will be measured after 12-week intervention]
patients will be assessed with empty bowel and bladder
systolic blood pressure [It will be measured after 12-week intervention]
it will be measured using sphygmomanometer
diastolic blood presure [It will be measured after 12-week intervention]
it will be measured using sphygmomanometer
waist circumference [It will be measured after 12-week intervention]
it will be measured by in elastic tape
blood glucose [It will be measured after 12-week intervention]
it will be measured in fasting status
triglycerides [It will be measured after 12-week intervention]
it will be measured in serum
high density lipoprotein [It will be measured after 12-week intervention]
it will be measured in serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

psoriatic married men with metabolic syndrome and erectile dysfunction

Exclusion Criteria:

patients with heart, respiratory, other autoimmune problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo Unoversity	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ali Ismail, lecturer, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Mohamed Ali ismail, lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University

ClinicalTrials.gov Identifier:

NCT05632042

Other Study ID Numbers: