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

NCT ID: NCT06893913

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2025-09-01

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

Conditions

Psoriasis; PreDiabetes; Obesity; Dry Eye

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

pyramidal training plus intermittent fasting

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

intermittent fasting

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ali Mohamed Ali ismail

Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali MA Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Faculty of physical therapy

Giza, Dokki, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ali MA Isamil, Lecturer

Role: CONTACT

ali.mohamed@pt.cu.edu.eg

0201005154209

hatem abdelfatah, Lecturer

Role: CONTACT

hatemfawzy@med.asu.edu.eg

02 01221594794

Facility Contacts

ali ismail, lecturer

Role: primary

ali.mohamed@pt.cu.edu.eg

02 01005154209

Other Identifiers

P.T.REC/012/004789

Identifier Type: -

Identifier Source: org_study_id