Effect of Addition of Pyramidal Exercise to Intermittent Fasting on Dryness of Eye in Pre-diabetic Psoriasis Patients

Not Applicable

Recruiting

• Conditions: Psoriasis; PreDiabetes; Obesity; Dry Eye

• Registration Number: NCT06893913
• Lead Sponsor: Cairo University

Brief Summary

insulin resistant psoriatic obese patients may complain problems of dryness of eye. Intermittent fasting may improve dryness of eye, obesity, insulin resistance, and psoriasis. Exercise, as applied in pyramidal form, if added to intermittent fasting may improve effect of intermittent fasting.

Detailed Description

forty obese patients with dryness of eye, obesity, insulin resistance (prediabetes), and psoriasis (chronic plaque) will randomly distributed to group I (n =20 patients) or group II (n=20). Both groups will receive The intermittent fasting regimen consisted of eating ad libitum for five days and then will restrict calories ('fasting') for two days per week, for a duration of 12 weeks. On the fasting days, participants will be instructed to restrict their calories to a maximum of 600 kcal/day for females and 650 kcal/day for males.

The intermittent fasting intervention will consist of a dietary intervention based on the 5:2 fasting diet. Subjects will be asked to consume a total of allowed calories in a window of 6 hours or less from 8:00 am till 2:00 pm, twice per week on 2 non-consecutive days.

Group I will receive a pyramidal training will be adopted for nearly 60 minutes (nearly two rounds of 21 minutes of running on electronic treadmill will be separated with 10 minutes of rest between the two rounds. Also, warming (4 minutes before start of pyrimidal trianing) and cooling (4 minutes after pyramidal training) will be done through gentle stretching exercises/activities. the exercise will be applied 3 times weekly for 2 weeks

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• chronic plaque psoriasis
• obesity class I
• prediabetic persons
• dryness of both eyes

Exclusion Criteria

• cardiac insults
• respiratory insults
• diabetics hypertensives or renal, hepatic insults

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
schrimer test	it will be assessed after 12 weeks	it is a test for eye dryness

Secondary Outcome Measures

Name	Time	Method
Tear film break-up timing	it will be assessed after 12 weeks	it is a test for eye dryness
System of Dry eye scoring	it will be assessed after 12 weeks	it is a questionnaire for eye dryness assessment
Ocular surface disability index	it will be assessed after 12 weeks	it is a questionnaire for eye dryness assessment
Dermatology life quality index	it will be assessed after 12 weeks	it is a questionnaire for psoriasis-associated life quality assessment
Psoriasis area and severity index	it will be assessed after 12 weeks	A PASI score is a tool used to measure the severity and extent of psoriasis. PASI is an acronym for Psoriasis Area and Severity Index.The PASI is a widely used instrument in psoriasis trials that assesses and grades the severity of psoriatic lesions. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).
Fasting serum blood glucose	it will be assessed after 12 weeks	it will measure of blood fasting glucose
Waist circumference	it will be assessed after 12 weeks	it will be assessed via tape
Body mass index	it will be assessed after 12 weeks	it will be assessed on empty stomach

Trial Locations

Locations (1)

Faculty of physical therapy; 🇪🇬 Giza, Dokki, Egypt