NCT05248698

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 21, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

February 7, 2022

Last Update Submit

February 16, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Schirmer's test

    tear-production speed test

    6 months

Secondary Outcomes (9)

  • scoring system for dry eye

    6 months

  • Ocular surface disability index

    6 months

  • tear film break up time testing

    6 months

  • Oxford grading system

    6 months

  • blood systole

    6 months

  • +4 more secondary outcomes

Study Arms (2)

group 1

EXPERIMENTAL

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

group 2

ACTIVE COMPARATOR

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

Interventions

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

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, for 6 months

group 2

Eligibility Criteria

Age65 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo Unoversity

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Dry Eye SyndromesFeeding BehaviorSedentary Behavior

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ali Ismail, lecturer

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Ismail, lecturer

CONTACT

Alshymaa Abdel Azeim, Lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 21, 2022

Study Start

January 5, 2022

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

February 21, 2022

Record last verified: 2022-02

Locations