Clinical trial NCT06893913: Effect of Addition of Pyramidal Exercise to Intermittent Fasting on Dryness of Eye in Pre-diabetic Psoriasis Patients
Official title: Effect of Addition of Pyramidal Exercise to Intermittent Fasting on Dryness of Eye in Pre-diabetic Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis
PreDiabetes
Obesity
Dry Eye
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: schrimer test
timeFrame: it will be assessed after 12 weeks
Secondary outcomes:
measure: Tear film break-up timing
timeFrame: it will be assessed after 12 weeks
measure: System of Dry eye scoring
timeFrame: it will be assessed after 12 weeks
measure: Ocular surface disability index
timeFrame: it will be assessed after 12 weeks
measure: Dermatology life quality index
timeFrame: it will be assessed after 12 weeks
measure: Psoriasis area and severity index
timeFrame: it will be assessed after 12 weeks
measure: Fasting serum blood glucose
timeFrame: it will be assessed after 12 weeks
measure: Waist circumference
timeFrame: it will be assessed after 12 weeks
measure: Body mass index
timeFrame: it will be assessed after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali MA Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: