Dry Eye Response to Interval Exercise and Mediterranean Diet

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05248698

Collaborator

(none)

Enrollment

Location

Arms

11.8

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Diet Habit Physical Inactivity	Behavioral: lifestyle change Other: exercise	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 5, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Schirmer's test [6 months]
tear-production speed test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo Unoversity	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Ali Ismail, lecturer, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ali Mohamed Ali ismail, principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT05248698

Other Study ID Numbers:

P.T.REC/012/003553

First Posted:

Feb 21, 2022

Last Update Posted:

Feb 21, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Study Results

No Results Posted as of Feb 21, 2022