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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Psoriasis; PreDiabetes; Dry Eye
• Intervention / Treatment: Behavioral: pyramidal training plus intermittent fasting; Behavioral: 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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali MA Isamil, Lecturer; Phone Number: 0201005154209; Email: ali.mohamed@pt.cu.edu.eg
• Study Contact Backup: Name: hatem abdelfatah, Lecturer; Phone Number: 02 01221594794; Email: hatemfawzy@med.asu.edu.eg

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt
      • Recruiting
      • Faculty of Physical Therapy
      • Contact: ali ismail, lecturer; Phone Number: 02 01005154209; Email: ali.mohamed@pt.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercised group; twenty obese patients with dryness of eye, obesity, (prediabetes), and psoriasis will receive intermittent fasting consisted of eating ad libitum for 5 days and then will restrict calories ('fasting') for two days weekly, for 12 weeks. On the fasting days, participants will restrict calories to a maximum of 600 kcal/day for females and 650 kcal/day for males. The dietary intervention will be 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. also this group will receive a pyramidal training nearly 60 minutes (nearly two rounds of 21 minutes of running on treadmill will be separated with 10 min of rest between the two rounds. Also, warming (4 min before start of pyrimidal trianing) and cooling (4 minu after pyramidal training) will be done through gentle stretching. the exercise will be applied 3 times weekly for 12 weeks	Behavioral: pyramidal training plus intermittent fasting; twenty obese patients with dryness of eye, obesity, (prediabetes), and psoriasis will receive intermittent fasting consisted of eating ad libitum for 5 days and then will restrict calories ('fasting') for two days weekly, for 12 weeks. On the fasting days, participants will restrict calories to a maximum of 600 kcal/day for females and 650 kcal/day for males. The dietary intervention will be 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. also this group will receive a pyramidal training nearly 60 minutes (nearly two rounds of 21 minutes of running on treadmill will be separated with 10 min of rest between the two rounds. Also, warming (4 min before start of pyrimidal trianing) and cooling (4 minu after pyramidal training) will be done through gentle stretching. the exercise will be applied 3 times weekly for 12 weeks
Active Comparator: non-exercised group; twenty obese patients with dryness of eye, obesity, insulin resistance (prediabetes), and psoriasis (chronic plaque) 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.	Behavioral: intermittent fasting; twenty obese patients with dryness of eye, obesity, (prediabetes), and psoriasis will receive intermittent fasting consisted of eating ad libitum for 5 days and then will restrict calories ('fasting') for two days weekly, for 12 weeks. On the fasting days, participants will restrict calories to a maximum of 600 kcal/day for females and 650 kcal/day for males. The dietary intervention will be 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
schrimer test	it is a test for eye dryness	it will be assessed after 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear film break-up timing	it is a test for eye dryness	it will be assessed after 12 weeks
System of Dry eye scoring	it is a questionnaire for eye dryness assessment	it will be assessed after 12 weeks
Ocular surface disability index	it is a questionnaire for eye dryness assessment	it will be assessed after 12 weeks
Dermatology life quality index	it is a questionnaire for psoriasis-associated life quality assessment	it will be assessed after 12 weeks
Psoriasis area and severity index	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).	it will be assessed after 12 weeks
Fasting serum blood glucose	it will measure of blood fasting glucose	it will be assessed after 12 weeks
Waist circumference	it will be assessed via tape	it will be assessed after 12 weeks
Body mass index	it will be assessed on empty stomach	it will be assessed after 12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Prediabetic State
• Other Study ID Numbers: P.T.REC/012/004789

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No