Determining The effect of vigorous physical activity on the ophthalmic symptoms of people with dry eye disease
Design
This study is an intervention and clinical trial and will be performed without blinding. Participants are grouped into blocks. The number of samples, including the drop, is predicted to be 60 people (30 people in the intervention group and 30 people in the control group). The work process is explained to them. People who score less than or equal to 10 according to the Shermer test criteria will be identified as patients with dry eye and will be included in the study. The intervention includes strenuous physical activity in the form of: modified cognitive exercise, jumping up and down and running for 12 weeks in the university gym. Exercises will be performed under the supervision of a sports expert. Data analysis is also performed using SPSS software version 21.
Settings and conduct
Shahid Mofteh Clinic in Yasuj
Participants/Inclusion and exclusion criteria
People referring to Shahid Mofteh Clinic in Yasuj with dry eyes who want to cooperate
Intervention groups
A group of 30 people with inclusion criteria.
Main outcome variables
Dry eyes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201209049654N1
Registration date:2020-12-12, 1399/09/22
Registration timing:registered_while_recruiting
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
farkhonde bakhshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3222 5141
Email address
fereshte.bakhshi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-09, 1399/09/19
Expected recruitment end date
2021-02-07, 1399/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of vigorous physical activity on the ophthalmic symptoms of people with dry eye disease
Public title
The effect of vigorous physical activity on the ophthalmic symptoms of people with dry eye disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having dry eye that has been approved by an ophthalmologist and obtaining a score less than or equal to 10 in the Shermer test and obtaining a score related to moderate and severe dry eye according to the relevant table in OSDI.2- Ability to exercise 3- Willingness to participate in research 4 - No heart disease 5- No cerebrovascular disease 6- No other eye diseases such as glaucoma and eye trauma 7- No contact lenses 8- No regular and continuous exercise during the last three months
Exclusion criteria:
- Temporary blockage of lacrimal ducts by inserting silicone rods 2- Using silicone materials to temporarily or permanently block the lacrimal duct cavity to preserve tears 3- Unwillingness to continue cooperation
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned to block between two groups. In the block method, the researcher creates 4 blocks by considering the number of groups, which are 2 groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Yasouj University of Medical Sciences
Street address
Yasuj-Shahid Jalil St.-School of Nursing
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591937770
Approval date
2020-07-21, 1399/04/31
Ethics committee reference number
IR.YUMS.REC.1399.100
Health conditions studied
1
Description of health condition studied
dry eye
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dry eyes
Timepoint
Trimester
Method of measurement
OSDI questionnaire and Shermer test
Secondary outcomes
empty
Intervention groups
1
Description
A group of 30 people are eligible to enter the study who perform the intervention, ie intense sports activity (Swedish swimming, jumping and running) during a three-month period in the gym under the supervision of a sports coach. Variable changes before and after the intervention It is measured using a questionnaire and a Shermer test.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mofteh Clinic in Yasuj
Full name of responsible person
Masoud Nikbakht
Street address
Yasuj, Imam Hossein Square, next to the Faculty of Health, Shahid Mofteh Clinic
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591937770
Phone
+98 74 3222 4541
Email
mdnibakht6293@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
حسین ماری اوریاد
Street address
Shahid Motahari Boulevard
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3334 6078
Email
oryad.hossein@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
mohammad latif rastian
Position
professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Ghorban Ali Jalil St., School of Nursing and Midwifery
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3222 4541
Email
m.rastian@yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
mohammad latif rastian
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahid Ghorban Ali Jalil St., School of Nursing and Midwifery
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3222 4541
Email
m.rastian@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
farkhonde bakhshi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Jalil St., School of Nursing and Midwifery
City
yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3222 4541
Email
fereshte.bakhshi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main implications of the data, including the impact of strenuous physical activity on reducing dry eye, will be shared
When the data will become available and for how long
The data will be available after the end of the study .
To whom data/document is available
The data will be available to researchers working in universities and research institutes.
Under which criteria data/document could be used
The data is provided with the permission of the University of Medical Sciences and only the results are used for further research
From where data/document is obtainable
Mohammad Latif Rastian. Email: m.rastian@yums.ac.ir
What processes are involved for a request to access data/document
The applicant must send a written request to the author of the article by e-mail and the author, after obtaining permission from Yasouj University of Medical Sciences, will provide the information to the applicant by e-mail for a maximum of 7 days.