Covid19NCT04958681
Changes in Physical Activity Status: Comparison of Older Adults With Versus Without a History of Covid-19 Infection
An observational study of Covid19, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The negative impact of the Covid-19 pandemic on the physical activity behavior of overall adults has been reported. But much less is known in older adults. Alterations in physical activity among Covid-19 survivors have not been investigated so far. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- exercise
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Jul 2021to 11 Sep 2021
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: The patients were matched with a control group of 76 community-dwelling older individuals without a Covid-19 diagnosis in the same period.
Who may be able to join
- 65 years non-dementia community dwelling older adults
Who cannot join
- The exclusion criteria were: (1) intensive care unit admission due to Covid-19 infection, (2) neurodegenerative or psychotic disease, (3) delirium, (4) terminal illness (malignancy, advanced organ failure), and (5) hearing impairment that disrupts conducting the telephone survey
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gulhane training and research hospital
Ankara, 06670
Bilal Katipoglu, MD, +905543330380, drbilal07@gmail.com
Mehmet I Naharcı, Prof
About this study
The negative impact of the Covid-19 pandemic on the physical activity behavior of overall adults has been reported. But much less is known in older adults. Alterations in physical activity among Covid-19 survivors have not been investigated so far. The present study aimed to evaluate the physical activity status of older adults in terms of a history of Covid-19 infection.
- Conditions
- Covid19
- Being tested
- exercise
- Keywords
- physical activity
- Medical subject headings
- COVID-19, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseOther
The participants were subsequently asked whether the pandemic had altered their physical activity status and rate the severity of reduction in mobility level compared to the period before the Covid-19 with the following options: none, 0; mild, 1; moderate, 2; severe, 3. Then, the participants were also asked whether they perform a physical exercise in a home setting. We recorded regular outdoor physical activity and home-based exercises (only after the pandemic) as a dichotomous variable (yes or no). The number of physical activity days per week was also obtained.
| Study group | Role | What they receive |
|---|---|---|
| Covid-19 history positive | Not described Receives: Other: exercise | |
| Covid-19 history negative | Not described Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
telephone based questionare related to frequency and duration of phyiscal activity
Measured: 1 year fellow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start21 Jul 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion11 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bilal Katipoglu, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958681
- Sponsor's protocol ID
- 2020-305
- Status last verified
- Jul 2021
- First submitted
- 7 Jul 2021
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Physical Activity Status: Comparison of Older Adults With Versus Without a History of Covid-19 Infection
- ClinicalTrials.gov ID
- NCT04958681
- Acronym / sponsor ID
- 2020-305
- Conditions
- Covid19
- Keywords
- physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 21 Jul 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 11 Sep 2021 (estimated)
- First posted
- 12 Jul 2021 (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.
The negative impact of the Covid-19 pandemic on the physical activity behavior of overall adults has been reported. But much less is known in older adults. Alterations in physical activity among Covid-19 survivors have not been investigated so far. The present study aimed to evaluate the physical activity status of older adults in terms of a history of Covid-19 infection.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 history positive | – | Other: exercise |
| Covid-19 history negative | – | Other: exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The patients were matched with a control group of 76 community-dwelling older individuals without a Covid-19 diagnosis in the same period.
Key inclusion criteria (1 listed)
- 65 years non-dementia community dwelling older adults
Key exclusion criteria (1 listed)
- The exclusion criteria were: (1) intensive care unit admission due to Covid-19 infection, (2) neurodegenerative or psychotic disease, (3) delirium, (4) terminal illness (malignancy, advanced organ failure), and (5) hearing impairment that disrupts conducting the telephone survey
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 |
|---|---|---|
| exerciseThe participants were subsequently asked whether the pandemic had altered their physical activity status and rate the severity of reduction in mobility level compared to the period before the Covid-19 with the following options: none, 0; mild, 1; moderate, 2; severe, 3. Then, the participants were also asked whether they perform a physical exercise in a home setting. We recorded regular outdoor physical activity and home-based exercises (only after the pandemic) as a dichotomous variable (yes or no). The number of physical activity days per week was also obtained. | Other | Covid-19 history negative, Covid-19 history positive |
Primary outcome
physical activity
Time frame: 1 year fellow-up
telephone based questionare related to frequency and duration of phyiscal activity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Gulhane Training and Research Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bilal Katipoglu, MD (+905543330380, drbilal07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical activity (time frame: 1 year fellow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2021.