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临床试验/NCT06893913
NCT06893913招募中不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
schrimer test

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

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

干预措施: pyramidal training plus intermittent fasting (Behavioral)

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.

干预措施: intermittent fasting (Behavioral)

结局指标

主要结局

schrimer test

时间窗: it will be assessed after 12 weeks

it is a test for eye dryness

次要结局

  • Fasting serum blood glucose(it will be assessed after 12 weeks)
  • Waist circumference(it will be assessed after 12 weeks)
  • Body mass index(it will be assessed after 12 weeks)
  • Tear film break-up timing(it will be assessed after 12 weeks)
  • System of Dry eye scoring(it will be assessed after 12 weeks)
  • Ocular surface disability index(it will be assessed after 12 weeks)
  • Dermatology life quality index(it will be assessed after 12 weeks)
  • Psoriasis area and severity index(it will be assessed after 12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ali Mohamed Ali ismail

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

Cairo University

研究点 (1)

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