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

May 17, 2023 updated by: Zahide Akeren, Bayburt University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Erzincan, Turkey, 24800
        • Erzincan Tercan State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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 green walking and intelligence game group
Other: green walking and intelligence gam
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.
Other Names:
  • control
Active Comparator: control 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
Other: green walking and intelligence gam
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.
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Investigation on the Cognitive Skills of Individuals Between the Ages of 50-70 Survived COVID-19 Disease
Time Frame: for a month
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
for a month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayburt University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karadeniz Technical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: ZAHİDE AKEREN, Bayburt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BayburtU
  • Karadeniz Technical University (Other Identifier: Karadeniz Technical University Faculty of Medicine Ethics Approval No: 2021/268.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Study Data/Documents

  1. Informed Consent Form
  2. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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