Is There a Benefit From Addition of Treadmill Walking to Diet Restriction in Psoriasis Women With PCOS?

December 4, 2025 updated by: Ali Mohamed Ali ismail, Cairo University
Women with psoriasis usually develop many complications including polysyctic ovarian syndrome (PCOS). Nowdays, diet restriction combimed with phsyical exercises may improve both problems

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Forty Women with psoriasis with PCOS will be enrolled to be catogrized to Group I or group II. Group I will enroll twenty females with PCOS and Psoriasis who will apply forty minutes walking on treadmill three times per week. Also Group I will follow low calorie diet and daily metformin for 12 weeks. Group II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt
        • Recruiting
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • obese (class I) women
  • chronic plaque psoriasis
  • polyscytic ovarian syndrome

Exclusion Criteria:

  • cardiac dysfucntions
  • liver diseases
  • repsiratory disease
  • vascular diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group number 1
Group I will enroll twenty females with PCOS and Psoriasis who will apply forty minutes walking on treadmill three times per week. Also Group I will follow low calorie diet and daily metformin for 12 weeks.
Behavioral: exercise and diet restriction
Group I will enroll twenty females with PCOS and Psoriasis who will apply forty minutes walking on treadmill three times per week for 12 weeks. Also Group I will follow low calorie diet and daily metformin for 12 weeks.
Active Comparator: group number 2
Group II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks
Behavioral: diet restriction
Group II will will enroll twenty females with PCOS and Psoriasis who will follow low calorie diet and daily metformin for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoariasis area and severity index
Time Frame: it will be measured after 12 weeks
is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area
it will be measured after 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
triglycerides
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
body mass index
Time Frame: It will be measured after 12 weeks
it will be assessed after emptying bladder and bowel
It will be measured after 12 weeks
waist circumference
Time Frame: It will be measured after 12 weeks
it will be measured at level of ambilicus
It will be measured after 12 weeks
waist hip ratio
Time Frame: It will be measured after 12 weeks
it will be assessed after dividing waist circumference on hip circumference
It will be measured after 12 weeks
testesterone
Time Frame: it will be measured after 12 weeks
it will be assessed in serum
it will be measured after 12 weeks
ratio of luteinizing hormone and follicle-stimulating hormone
Time Frame: It will be measured after 12 weeks
it is anindicator on function of sex hormones
It will be measured after 12 weeks
Dehydroepiandrosterone
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
Dermatology life Quality Index
Time Frame: It will be measured after 12 weeks
it assess impact of skin disease on quality of life
It will be measured after 12 weeks
insuiln
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
fasting blood glucose
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
HOMA-IR
Time Frame: It will be measured after 12 weeks
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) is classically considered to be a good insulin resistance (IR) index
It will be measured after 12 weeks
total cholesterol
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
high density lipoprotein
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
low density lipoprotein
Time Frame: It will be measured after 12 weeks
it will be assessed in plasma
It will be measured after 12 weeks
systolic blood pressure
Time Frame: It will be measured after 12 weeks
it will be assessed via manual sphygmmanometer
It will be measured after 12 weeks
diatolic blood pressure
Time Frame: It will be measured after 12 weeks
it will be assessed via manual sphygmmanometer
It will be measured after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Ali MA Ismail, lecturer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2026

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00014233-58

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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