Menu
Recruiting NCT06893913

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

No phase Interventional Psoriasis PreDiabetes Obesity Dry Eye

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pyramidal training plus intermittent fasting, intermittent fasting.
Who it may be relevant to
Registry conditions: Psoriasis, PreDiabetes, Obesity, Dry Eye. Basic parameters: 45 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Interventions

  • 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
  • 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

Primary outcome measures

  • schrimer test [Time frame: it will be assessed after 12 weeks]
Secondary outcome measures (8)
  • Tear film break-up timing [Time frame: it will be assessed after 12 weeks]
  • System of Dry eye scoring [Time frame: it will be assessed after 12 weeks]
  • Ocular surface disability index [Time frame: it will be assessed after 12 weeks]
  • Dermatology life quality index [Time frame: it will be assessed after 12 weeks]
  • Psoriasis area and severity index [Time frame: it will be assessed after 12 weeks]
  • Fasting serum blood glucose [Time frame: it will be assessed after 12 weeks]
  • Waist circumference [Time frame: it will be assessed after 12 weeks]
  • Body mass index [Time frame: it will be assessed after 12 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of physical therapy — Giza

Identifiers

NCT: NCT06893913 · P.T.REC/012/004789

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗