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

NCT05632042 | Unknown

• 1 other identifier: P.T.REC/012/004117
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis; Metabolic Syndrome; Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• International Index of Erectile Function

  Arabic version of this 5-item questionnaire will used to assess erectile function/dysfunction

  It will be measured after 12-week intervention

Secondary Outcomes (8)

• psoriasis area and severity index

  It will be measured after 12-week intervention

• body mass index

  It will be measured after 12-week intervention

• systolic blood pressure

  It will be measured after 12-week intervention

• diastolic blood presure

  It will be measured after 12-week intervention

• waist circumference

  It will be measured after 12-week intervention

Study Arms (2)

lifestyle-modification group

EXPERIMENTAL

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)

control group

NO INTERVENTION

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

Interventions

lifestyle modification (exercise and control of diet) BEHAVIORAL

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)

lifestyle-modification group

Eligibility Criteria

• Age: 35 Years - 45 Years
• Gender Eligibility Details: based on self-representation of gender identity
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• psoriatic married men with metabolic syndrome and erectile dysfunction

You may not qualify if:

• patients with heart, respiratory, other autoimmune problems

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Psoriasis; Metabolic Syndrome; Erectile Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ali Ismail, lecturer

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

02 01005154209; ali.mohamed@pt.cu.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: lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: October 16, 2022
• Primary Completion: April 16, 2023
• Study Completion: April 16, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

EG (1)