search
Back to results

Dry Eye Response to Interval Exercise and Mediterranean Diet

Primary Purpose

Dry Eye, Diet Habit, Physical Inactivity

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lifestyle change
exercise
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elderly patients with dry eye complaints
  • the patients will be obese and hypertensives

Exclusion Criteria:

  • heart or respiration problems
  • other diagnosed eye or systemic diseases

Sites / Locations

  • Cairo UnoversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group 1

group 2

Arm Description

30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet for 6 months

30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, for 6 months

Outcomes

Primary Outcome Measures

Schirmer's test
tear-production speed test

Secondary Outcome Measures

scoring system for dry eye
it is a questionnaire will assess dry-eye severity
Ocular surface disability index
it is a questionnaire will assess complaints of patients due to severity of dry-eye
tear film break up time testing
it is a test that will assess tear film stabilization
Oxford grading system
a test will examine ocular epithelial damage
blood systole
it will be measured by sphygmomanometer
blood diastole
it will be measured by sphygmomanometer
weight
it will be expressed in kilograms
body mass index
it will be gained by dividing weight of subject on his or her squared height
waist circumference
it will be evaluated by tape measurements of treatment

Full Information

First Posted
February 7, 2022
Last Updated
February 16, 2022
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT05248698
Brief Title
Dry Eye Response to Interval Exercise and Mediterranean Diet
Official Title
Dry Eye Response to Interval Exercise (High Intensity Aerobic Activity) and Mediterranean Diet
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
in the recent times, dry eye was found to be correlated sedentary life style, obesity, hypertension. So, changing the sedentary lifestyle is recommended
Detailed Description
older patient who will complain from dry eye will be collected. it is planned to recruit 60 elderly (with obesity and hypertension) to be distributed into group 1 (this group will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet) and group 2 (this group will receive only 3-time interval exercise per the week, applied for 30 min with high intensity). Every group will contain 30 elderly

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye, Diet Habit, Physical Inactivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet for 6 months
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, for 6 months
Intervention Type
Behavioral
Intervention Name(s)
lifestyle change
Intervention Description
30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, plus Mediterranean Diet for 6 months
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
30 older patient who will complain from dry eye will receive 3-time interval exercise per the week, applied for 30 min with high intensity, for 6 months
Primary Outcome Measure Information:
Title
Schirmer's test
Description
tear-production speed test
Time Frame
6 months
Secondary Outcome Measure Information:
Title
scoring system for dry eye
Description
it is a questionnaire will assess dry-eye severity
Time Frame
6 months
Title
Ocular surface disability index
Description
it is a questionnaire will assess complaints of patients due to severity of dry-eye
Time Frame
6 months
Title
tear film break up time testing
Description
it is a test that will assess tear film stabilization
Time Frame
6 months
Title
Oxford grading system
Description
a test will examine ocular epithelial damage
Time Frame
6 months
Title
blood systole
Description
it will be measured by sphygmomanometer
Time Frame
6 months
Title
blood diastole
Description
it will be measured by sphygmomanometer
Time Frame
6 months
Title
weight
Description
it will be expressed in kilograms
Time Frame
6 months
Title
body mass index
Description
it will be gained by dividing weight of subject on his or her squared height
Time Frame
6 months
Title
waist circumference
Description
it will be evaluated by tape measurements of treatment
Time Frame
6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity.
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elderly patients with dry eye complaints the patients will be obese and hypertensives Exclusion Criteria: heart or respiration problems other diagnosed eye or systemic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alshymaa Abdel Azeim, Lecturer
Phone
02 0103377553
Email
shimaashaaban30@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Dry Eye Response to Interval Exercise and Mediterranean Diet

We'll reach out to this number within 24 hrs