Dry Eye Response to Interval Exercise and Mediterranean Diet

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05248698
• Other study ID #: P.T.REC/012/003553
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Habit
• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Physical Inactivity

Intervention

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

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

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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