PsoriasisNCT06893913
Effect of Addition of Pyramidal Exercise to Intermittent Fasting on Dryness of Eye in Pre-diabetic Psoriasis Patients
A study testing pyramidal training plus intermittent fasting and intermittent fasting in people with Psoriasis and PreDiabetes, run by Cairo University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Psoriasis, PreDiabetes, Obesity
- What is being tested?
- pyramidal training plus intermittent fasting and intermittent fasting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic plaque psoriasis
- obesity class I
- prediabetic persons
- dryness of both eyes
Who cannot join
- cardiac insults
- respiratory insults
- diabetics hypertensives or renal, hepatic insults
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza, Dokki
ali ismail, lecturer, 02 01005154209, ali.mohamed@pt.cu.edu.eg
About this study
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
- Conditions
- Psoriasis, PreDiabetes, Obesity, Dry Eye
- Being tested
- pyramidal training plus intermittent fasting, intermittent fasting
- Medical subject headings
- Psoriasis, Prediabetic State, Obesity, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyramidal training plus intermittent fastingBehavioural
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
intermittent fastingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| exercised group | Experimental | 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 Receives: Behavioral: pyramidal training plus intermittent fasting |
| non-exercised group | Active comparator | 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. Receives: Behavioral: intermittent fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
schrimer test
it is a test for eye dryness
Measured: it will be assessed after 12 weeks
Secondary outcomes (8)
Tear film break-up timing
it is a test for eye dryness
Measured: it will be assessed after 12 weeks
System of Dry eye scoring
it is a questionnaire for eye dryness assessment
Measured: it will be assessed after 12 weeks
Ocular surface disability index
it is a questionnaire for eye dryness assessment
Measured: it will be assessed after 12 weeks
Dermatology life quality index
it is a questionnaire for psoriasis-associated life quality assessment
Measured: 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).
Measured: it will be assessed after 12 weeks
Fasting serum blood glucose
it will measure of blood fasting glucose
Measured: it will be assessed after 12 weeks
Waist circumference
it will be assessed via tape
Measured: it will be assessed after 12 weeks
Body mass index
it will be assessed on empty stomach
Measured: it will be assessed after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali MA Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893913
- Sponsor's protocol ID
- P.T.REC/012/004789
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Addition of Pyramidal Exercise to Intermittent Fasting on Dryness of Eye in Pre-diabetic Psoriasis Patients
- ClinicalTrials.gov ID
- NCT06893913
- Acronym / sponsor ID
- P.T.REC/012/004789
- Conditions
- Psoriasis, PreDiabetes, Obesity, Dry Eye
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercised group | Experimental | Behavioral: pyramidal training plus intermittent fastingtwenty 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 | Active comparator | Behavioral: intermittent fastingtwenty 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. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- chronic plaque psoriasis
- obesity class I
- prediabetic persons
- dryness of both eyes
Key exclusion criteria (3 listed)
- cardiac insults
- respiratory insults
- diabetics hypertensives or renal, hepatic insults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pyramidal training plus intermittent fastingtwenty 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 | Behavioural | exercised group |
| intermittent fastingtwenty 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. | Behavioural | non-exercised group |
Primary outcome
schrimer test
Time frame: it will be assessed after 12 weeks
it is a test for eye dryness
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali MA Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pyramidal training plus intermittent fasting and intermittent fasting in people with Psoriasis and PreDiabetes, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali MA Isamil, Lecturer (0201005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
schrimer test (time frame: it will be assessed after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.