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Investigation of the Effect on Cognitive Skills of COVID-19 Survivors (Cognitive)

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
green walking and intelligence gam
Sponsored by
Bayburt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for COVID-19 focused on measuring COVID-19, Attention, Nature, Memory, Intelligence, Walking

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Electronic records and contact information (address, telephone) of individuals who were diagnosed with COVID-19 in Erzincan Tercan State Hospital and whose COVID-19 test became negative within one year after being placed in home quarantine with outpatient treatment, Individuals are between the ages of 50-70, A score of 20 or less on the Montreal Cognitive Assessment Scale, To be at least primary school graduate, Being residing in the Tercan district of Erzincan, Being able to perform self-care activities independently, Good general condition, Having a smart phone or having a smart phone in one person in the household, For individuals in the trekking and intelligence game group, for one month It indicates that there is no harm in taking a nature walk for 30 minutes three days a week, having the approval of the physician. Agreeing to participate in the research. Exclusion Criteria for Research Positive COVID-19 (PCR) test result, Being visually and hearing impaired, Having a balance problem Using a cane or walker while walking, Being dependent on a bed or a wheelchair, Parkinson's, dementia, Alzheimer's diagnosis, Getting a diagnosis of cancer, Having a history of central nervous system disease that may cause cognitive dysfunction (stroke, head trauma, tumor, epilepsy, movement disorder diseases), Using antipsychotics, antidepressants, mood stabilizers, antiepileptics, benzodiazepines and medications that may interfere with the evaluation, Having undergone any surgery to prevent walking, Having a condition that prevents walking (musculoskeletal problems, joint problems, fracture, neuropathy, chronic severe pain, loss of limb). Exclusion Criteria Do not be hospitalized for any reason, Change of residence, emigration, death, Having an infection that requires isolation, Worsening of the general condition, Inclusion in another aerobic exercise program, Unwillingness to continue research.

Sites / Locations

  • Erzincan Tercan State Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

green walking and intelligence game group

control group

Arm Description

The randomized controlled study to examine the effects of green walking and intelligence games on the cognitive skills of individuals aged 50-70 years who had COVID-19 on an outpatient basis were completed with 40 individuals, 20 of which were in the green walking and intelligence game group

The randomized controlled study to examine the effects of green walking and intelligence games on the cognitive skills of individuals aged 50-70 years who had COVID-19 on an outpatient basis were completed with 40 individuals, 20 of which were in the 20 were in the control group

Outcomes

Primary Outcome Measures

Investigation on the Cognitive Skills of Individuals Between the Ages of 50-70 Survived COVID-19 Disease
Examine the effects of green walking and intelligence games on the cognitive skills of individuals aged 50-70 years who had COVID-19 on an outpatient basis were completed with individuals

Secondary Outcome Measures

Full Information

First Posted
April 7, 2023
Last Updated
May 17, 2023
Sponsor
Bayburt University
Collaborators
Karadeniz Technical University
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1. Study Identification

Unique Protocol Identification Number
NCT05866263
Brief Title
Investigation of the Effect on Cognitive Skills of COVID-19 Survivors
Acronym
Cognitive
Official Title
Investigation of the Effect Of Green Walking and Intelligence Games on the Cognitive Skills of Individuals Between the Ages of 50-70 Survived COVID-19 Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
January 3, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bayburt University
Collaborators
Karadeniz Technical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigation of the Effect Of Green Walking and Intelligence Games on the Cognitive Skills of Individuals Between the Ages of 50-70 Survived COVID-19 Disease The randomized controlled study to examine the effects of green walking and intelligence games on the cognitive skills of individuals aged 50-70 years who had COVID-19 on an outpatient basis were completed with 40 individuals, 20 of which were in the green walking and intelligence game group and 20 were in the control group.
Detailed Description
The data were collected in Erzincan Tercan State Hospital between January-May 2022, "Patient Information Form," "Montreal Cognitive Assessment Implementation Guideline," "Brain Games (Brain Games-Memory Thinking and Brain Exercise) Information Leaflet," "Hiking Information Brochure," and "Experimental Group Follow-up Form" by the "Montreal Cognitive Assessment Scale" applied as a pre-test. As an initiative, the green walking and intelligence game group was given a 30-minute nature walk three days a week for a month and a 15-minute intelligence game practice every day. Then, the "Montreal Cognitive Assessment Scale" was applied as a post-test.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Attention, Nature, Memory, Intelligence, Walking

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
COVID-19 on an outpatient basis were completed with 40 individuals, 20 of which were in the green walking and intelligence game group and 20 were in the control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
green walking and intelligence game group
Arm Type
Experimental
Arm Description
The randomized controlled study to examine the effects of green walking and intelligence games on the cognitive skills of individuals aged 50-70 years who had COVID-19 on an outpatient basis were completed with 40 individuals, 20 of which were in the green walking and intelligence game group
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The randomized controlled study to examine the effects of green walking and intelligence games on the cognitive skills of individuals aged 50-70 years who had COVID-19 on an outpatient basis were completed with 40 individuals, 20 of which were in the 20 were in the control group
Intervention Type
Other
Intervention Name(s)
green walking and intelligence gam
Other Intervention Name(s)
control
Intervention Description
The randomized controlled study to examine the effects of green walking and intelligence games on the cognitive skills of individuals aged 50-70 years who had COVID-19 on an outpatient basis were completed with 40 individuals, 20 of which were in the green walking and intelligence game group and 20 were in the control group.
Primary Outcome Measure Information:
Title
Investigation on the Cognitive Skills of Individuals Between the Ages of 50-70 Survived COVID-19 Disease
Description
Examine the effects of green walking and intelligence games on the cognitive skills of individuals aged 50-70 years who had COVID-19 on an outpatient basis were completed with individuals
Time Frame
for a month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Electronic records and contact information (address, telephone) of individuals who were diagnosed with COVID-19 in Erzincan Tercan State Hospital and whose COVID-19 test became negative within one year after being placed in home quarantine with outpatient treatment, Individuals are between the ages of 50-70, A score of 20 or less on the Montreal Cognitive Assessment Scale, To be at least primary school graduate, Being residing in the Tercan district of Erzincan, Being able to perform self-care activities independently, Good general condition, Having a smart phone or having a smart phone in one person in the household, For individuals in the trekking and intelligence game group, for one month It indicates that there is no harm in taking a nature walk for 30 minutes three days a week, having the approval of the physician. Agreeing to participate in the research. Exclusion Criteria for Research Positive COVID-19 (PCR) test result, Being visually and hearing impaired, Having a balance problem Using a cane or walker while walking, Being dependent on a bed or a wheelchair, Parkinson's, dementia, Alzheimer's diagnosis, Getting a diagnosis of cancer, Having a history of central nervous system disease that may cause cognitive dysfunction (stroke, head trauma, tumor, epilepsy, movement disorder diseases), Using antipsychotics, antidepressants, mood stabilizers, antiepileptics, benzodiazepines and medications that may interfere with the evaluation, Having undergone any surgery to prevent walking, Having a condition that prevents walking (musculoskeletal problems, joint problems, fracture, neuropathy, chronic severe pain, loss of limb). Exclusion Criteria Do not be hospitalized for any reason, Change of residence, emigration, death, Having an infection that requires isolation, Worsening of the general condition, Inclusion in another aerobic exercise program, Unwillingness to continue research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZAHİDE AKEREN
Organizational Affiliation
Bayburt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erzincan Tercan State Hospital
City
Erzincan
ZIP/Postal Code
24800
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Application of the Experimental Group Follow-up Form The nature of the individuals in the green walking and intelligence game group were recorded by the researcher on the Experiment Group Follow-up Form 12 times, three days a week, on the day of the trek. In addition, the situation of playing the intelligence game of this group of individuals is a test for each individual. In addition, the state of playing intelligence games of this group of individuals was recorded by the researcher in the Experimental Group Follow-up Form by making 30 phone calls, including once a day for a month, for each individual.
IPD Sharing Time Frame
January-May 2022
IPD Sharing Access Criteria
The work has been completed and is not accessible.
Citations:
PubMed Identifier
23405164
Citation
Nouchi R, Taki Y, Takeuchi H, Hashizume H, Nozawa T, Kambara T, Sekiguchi A, Miyauchi CM, Kotozaki Y, Nouchi H, Kawashima R. Brain training game boosts executive functions, working memory and processing speed in the young adults: a randomized controlled trial. PLoS One. 2013;8(2):e55518. doi: 10.1371/journal.pone.0055518. Epub 2013 Feb 6.
Results Reference
result
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/23405164/
Description
https://pubmed.ncbi.nlm.nih.gov/23405164/
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/23405164/
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/23405164/

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Investigation of the Effect on Cognitive Skills of COVID-19 Survivors

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