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RecruitingNCT06893913Updated Mar 25, 2025

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

An interventional study of pyramidal training plus intermittent fasting and intermittent fasting in Psoriasis, PreDiabetes and Obesity, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 45 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-03-25.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
45 Years to 55 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Psoriasis
  • PreDiabetes
  • Obesity
  • Dry Eye
03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's planned enrollment of 40 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • cardiac insults
  • respiratory insults
  • diabetics hypertensives or renal, hepatic insults
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • Behavioralpyramidal 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

  • Behavioralintermittent 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.

06

What researchers measure

Primary outcomes

  1. schrimer test

    it is a test for eye dryness

    Time frame: it will be assessed after 12 weeks

Secondary outcomes

  1. Tear film break-up timing

    it is a test for eye dryness

    Time frame: it will be assessed after 12 weeks

  2. System of Dry eye scoring

    it is a questionnaire for eye dryness assessment

    Time frame: it will be assessed after 12 weeks

  3. Ocular surface disability index

    it is a questionnaire for eye dryness assessment

    Time frame: it will be assessed after 12 weeks

  4. Dermatology life quality index

    it is a questionnaire for psoriasis-associated life quality assessment

    Time frame: it will be assessed after 12 weeks

  5. 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).

    Time frame: it will be assessed after 12 weeks

  6. Fasting serum blood glucose

    it will measure of blood fasting glucose

    Time frame: it will be assessed after 12 weeks

  7. Waist circumference

    it will be assessed via tape

    Time frame: it will be assessed after 12 weeks

  8. Body mass index

    it will be assessed on empty stomach

    Time frame: it will be assessed after 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Faculty of physical therapy
    Giza, Dokki, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06893913
Lead sponsor
Cairo University
Responsible party
Ali Mohamed Ali ismail (Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University) — Principal investigator
First posted
Mar 25, 2025
Start date
Mar 1, 2025
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 1, 2025 (estimated)
Last update
Mar 25, 2025

Study contacts

Ali MA Isamil, Lecturer
Contact
ali.mohamed@pt.cu.edu.eg
0201005154209
hatem abdelfatah, Lecturer
Contact
hatemfawzy@med.asu.edu.eg
02 01221594794
Ali MA Ismail, lecturer
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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