COVID-19CognitiveNCT05866263
Investigation of the Effect on Cognitive Skills of COVID-19 Survivors
A study testing green walking and intelligence gam in people with COVID-19, run by Bayburt University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- green walking and intelligence gam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Mar 2021to 17 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
- Unwillingness to continue research.
Who cannot join
- 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,
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- 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).
- Do not be hospitalized for any reason,
- Change of residence, emigration, death,
- Having an infection that requires isolation,
- Worsening of the general condition,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Tercan State Hospital
Erzincan, 24800
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- green walking and intelligence gam
- Keywords
- COVID-19, Attention, Nature, Memory, Intelligence, Walking
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
green walking and intelligence gamOther
Also called control
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 group | Role | What they receive |
|---|---|---|
| green walking and intelligence game group | Experimental | 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 Receives: Other: green walking and intelligence gam |
| control group | Active comparator | 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 Receives: Other: green walking and intelligence gam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: for a month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start23 Mar 2021
- Primary completion3 Jan 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayburt University
- Sponsor type
- University, hospital or other
- Collaborators
- Karadeniz Technical University
- Responsible party
- Principal investigator, Zahide Akeren, Bayburt University
- Investigators
- ZAHİDE AKEREN, Principal investigator, Bayburt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866263
- Sponsor's protocol ID
- BayburtU
- Other IDs
- Karadeniz Technical University
- Acronym
- Cognitive
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 23405164
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05866263
- Acronym / sponsor ID
- Cognitive / BayburtU
- Conditions
- COVID-19
- Keywords
- COVID-19, Attention, Nature, Memory, Intelligence, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bayburt UniversityUniversity, hospital or other
- Collaborators
- Karadeniz Technical University
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| green walking and intelligence game group | Experimental | Other: green walking and intelligence gamThe 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 |
| control group | Active comparator | Other: green walking and intelligence gamThe 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 |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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,
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| green walking and intelligence gamAlso: controlThe 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 | control group, green walking and intelligence game group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Results publication: PubMed 23405164Nouchi 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.
- https://pubmed.ncbi.nlm.nih.gov/23405164/Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ZAHİDE AKEREN principal investigator
Bayburt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green walking and intelligence gam in people with COVID-19, run by Bayburt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation on the Cognitive Skills of Individuals Between the Ages of 50-70 Survived COVID-19 Disease (time frame: for a month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.