Dry Eye Response to Interval Exercise and Mediterranean Diet

February 16, 2022 updated by: Ali Mohamed Ali ismail, Cairo University

Dry Eye Response to Interval Exercise (High Intensity Aerobic Activity) and Mediterranean Diet

in the recent times, dry eye was found to be correlated sedentary life style, obesity, hypertension. So, changing the sedentary lifestyle is recommended

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
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
Behavioral: lifestyle change
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
Active Comparator: group 2
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
Other: exercise
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer's test
Time Frame: 6 months
tear-production speed test
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scoring system for dry eye
Time Frame: 6 months
it is a questionnaire will assess dry-eye severity
6 months
Ocular surface disability index
Time Frame: 6 months
it is a questionnaire will assess complaints of patients due to severity of dry-eye
6 months
tear film break up time testing
Time Frame: 6 months
it is a test that will assess tear film stabilization
6 months
Oxford grading system
Time Frame: 6 months
a test will examine ocular epithelial damage
6 months
blood systole
Time Frame: 6 months
it will be measured by sphygmomanometer
6 months
blood diastole
Time Frame: 6 months
it will be measured by sphygmomanometer
6 months
weight
Time Frame: 6 months
it will be expressed in kilograms
6 months
body mass index
Time Frame: 6 months
it will be gained by dividing weight of subject on his or her squared height
6 months
waist circumference
Time Frame: 6 months
it will be evaluated by tape measurements of treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

December 30, 2022

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 21, 2022

Study Record Updates

Last Update Posted (Actual)

February 21, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003553

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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