Covid19NCT04745923
Physical Activity Level in Patients with Chronic Kidney Disease During COVID-19 Pandemic
An observational study of Covid19 and Chronic Kidney Diseases, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In the literature, there are no studies evaluating fear of COVID-19, anxiety, depression, physical activity, fear of movement and quality of life in patients with chronic kidney disease during COVID-19 pandemic. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19, Chronic Kidney Diseases
- How many people
- 190 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2021to 30 Sep 2022
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and healthy individuals between 18-65 years old, who are diagnosed with chronic kidney disease, and whose local language is Turkish will be included in the study.
Who may be able to join
- Having been diagnosed with chronic kidney disease
- Being clinically stable
- Volunteering to participate in the research
Who cannot join
- Having a cognitive problem
- Not being literate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University, Faculty of Physical Therapy and Rehabilitation
Ankara
About this study
Official title: Fear of COVID-19 and Physical Activity Level in Patients with Chronic Kidney Disease During COVID-19 Pandemic
In the literature, there are no studies evaluating fear of COVID-19, anxiety, depression, physical activity, fear of movement and quality of life in patients with chronic kidney disease during COVID-19 pandemic. The investigators will evaluate these parameters in patients with chronic kidney disease and compare the findings of healthy individuals during COVID-19 pandemic
- Conditions
- Covid19, Chronic Kidney Diseases
- Keywords
- Fear, Quality of life, Anxiety, Depression
- Medical subject headings
- COVID-19, Renal Insufficiency, Chronic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic kidney disease | Having been diagnosed with chronic kidney disease | |
| Healthy individuals | Healthy individuals without chronic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of COVID-19
COVID-19 phobia will be evaluated using Fear of COVID-19 Scale.
Measured: 5 minutes
Physical activity
Physical activity level will be evaluated using International Physical Activity Questionnaire - Short Form (IPAQ-SF).
Measured: 5 minutes
Secondary outcomes (3)
Qol
Quality of life will be evaluated using SF-36
Measured: 10 minutes
Anxiety and depression
Anxiety and depression will be evaluated using Hospital Anxiety and Depression scale (HADS).
Measured: 5 minutes
Fear of movement
Fear of movement will be evaluated using the Tampa Scale for Kinesiophobia
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start20 Jan 2021
- Primary completion28 Feb 2021
- Study completion30 Sep 2022
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.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Firat, Hacettepe University
- Investigators
- Merve Firat, MSc, Principal investigator, Hacettepe UniversityNaciye Vardar-Yagli, PhD, Study director, Hacettepe UniversityTolga Yildirim, MD, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745923
- Sponsor's protocol ID
- GO 21/127
- Status last verified
- Jan 2021
- First submitted
- 6 Feb 2021
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of COVID-19 and Physical Activity Level in Patients with Chronic Kidney Disease During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04745923
- Acronym / sponsor ID
- GO 21/127
- Conditions
- Covid19, Chronic Kidney Diseases
- Keywords
- Fear, Quality of life, Anxiety, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 9 Feb 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.
In the literature, there are no studies evaluating fear of COVID-19, anxiety, depression, physical activity, fear of movement and quality of life in patients with chronic kidney disease during COVID-19 pandemic. The investigators will evaluate these parameters in patients with chronic kidney disease and compare the findings of healthy individuals during COVID-19 pandemic
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic kidney disease | – | –Having been diagnosed with chronic kidney disease |
| Healthy individuals | – | –Healthy individuals without chronic disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and healthy individuals between 18-65 years old, who are diagnosed with chronic kidney disease, and whose local language is Turkish will be included in the study.
Key inclusion criteria (3 listed)
- Having been diagnosed with chronic kidney disease
- Being clinically stable
- Volunteering to participate in the research
Key exclusion criteria (2 listed)
- Having a cognitive problem
- Not being literate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fear of COVID-19
Time frame: 5 minutes
COVID-19 phobia will be evaluated using Fear of COVID-19 Scale.
Physical activity
Time frame: 5 minutes
Physical activity level will be evaluated using International Physical Activity Questionnaire - Short Form (IPAQ-SF).
3 secondary outcomes
Qol
Time frame: 10 minutes
Anxiety and depression
Time frame: 5 minutes
Fear of movement
Time frame: 10 minutes
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 7 Nov 2024.
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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.
Merve Firat, MSc principal investigator
Hacettepe University
Naciye Vardar-Yagli, PhD study director
Hacettepe University
Tolga Yildirim, MD study chair
Hacettepe University
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 and Chronic Kidney Diseases, run by Hacettepe 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 3 inclusion and 2 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 7 Nov 2024. 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?
Fear of COVID-19 (time frame: 5 minutes). The study lists 2 primary outcomes in all. 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 7 Nov 2024.