COVID-19 InfectionCOVID-19NCT06528145
Long Covid (Individuals with Ongoing COVID-19 Symptoms) Ongoing Effects
An observational study of COVID-19 Infection, run by Ziya Yildiz at 1 site in Turkey (Türkiye).
Trial summary
Persistent Covid-19 symptoms, known as long Covid, can impact healthcare provision. This study aimed to assess how symptoms persisting six months after Covid-19 affect quality of life and functional capacity. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- COVID-19 Infection
- What is being tested?
- Evalation
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2021to 20 Feb 2023
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who had an infection at Süleyman Demirel University Hospital at least 6 and up to 18 months ago and were re-admitted to the hospital due to symptoms were included.
Who may be able to join
- The study included individuals who had Covid-19 disease at least 6-18 months ago, who agreed to participate, and who were diagnosed with Covid-19 by a health institu-tion during the disease period.
Who cannot join
- Individuals who were not between the ages of 18-65, who had cognitive and commu-nicative impairments, and who had orthopedic and neurological limitations that would prevent them from performing physical activity were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Süleyman Demirel Univesity
Isparta, Isparta, 32000
About this study
Official title: Comparison of Quality of Life and Functional Capacity of Long Covid Patients and Symptom-Free Volunteers: a Randomized Controlled Study
Persistent Covid-19 symptoms, known as long Covid, can impact healthcare provision. This study aimed to assess how symptoms persisting six months after Covid-19 affect quality of life and functional capacity.
- Conditions
- COVID-19 Infection
- Being tested
- Evalation
- Keywords
- Long Covid, Quality of Life, COVID-19
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EvalationOther
Post Covid Functional Scale (PCFS) was used to assess the functional status of the participants; Short Form- 36 (SF-36) questionnaire was used to assess quality of life; 30 s sit-to-stand test (30s-STS) and 6 min walk test (6 MWT) were used to assess functional capacity.
| Study group | Role | What they receive |
|---|---|---|
| S- | Individuals who have not had symptoms for 6-18 months after Covid infection Receives: Other: Evalation | |
| S+ | Individuals with ongoing symptoms 6-18 months after Covid infection Receives: Other: Evalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity, physical function, physical role difficulties, emotional role difficulties, pain and general health
Functional capacity was affected more in the group whose symptoms persisted than in the group whose symptoms did not persist (p<0.05). Some of the SF-36 sub-parameters (physical function, physical role difficulties, emotional role difficulties, pain and general health) were found to be sig-nificantly more affected in participants with persistent symptoms (p<0.05).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start25 Sep 2021
- Primary completion2 Dec 2022
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 InfectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziya Yildiz
- Sponsor type
- University, hospital or other
- Collaborators
- Suleyman Demirel University, Pamukkale University
- Responsible party
- Sponsor-investigator, Ziya Yildiz, Isparta University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06528145
- Sponsor's protocol ID
- SülDemirelUni_YildizA_002
- Acronym
- COVID-19
- Status last verified
- Feb 2025
- First submitted
- 29 Jul 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Quality of Life and Functional Capacity of Long Covid Patients and Symptom-Free Volunteers: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06528145
- Acronym / sponsor ID
- COVID-19 / SülDemirelUni_YildizA_002
- Conditions
- COVID-19 Infection
- Keywords
- Long Covid, Quality of Life, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ziya YildizUniversity, hospital or other
- Collaborators
- Suleyman Demirel University, Pamukkale University
- Study start
- 25 Sep 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 30 Jul 2024 (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.
Persistent Covid-19 symptoms, known as long Covid, can impact healthcare provision. This study aimed to assess how symptoms persisting six months after Covid-19 affect quality of life and functional capacity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S- | – | Other: EvalationIndividuals who have not had symptoms for 6-18 months after Covid infection |
| S+ | – | Other: EvalationIndividuals with ongoing symptoms 6-18 months after Covid infection |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who had an infection at Süleyman Demirel University Hospital at least 6 and up to 18 months ago and were re-admitted to the hospital due to symptoms were included.
Key inclusion criteria (1 listed)
- The study included individuals who had Covid-19 disease at least 6-18 months ago, who agreed to participate, and who were diagnosed with Covid-19 by a health institu-tion during the disease period.
Key exclusion criteria (1 listed)
- Individuals who were not between the ages of 18-65, who had cognitive and commu-nicative impairments, and who had orthopedic and neurological limitations that would prevent them from performing physical activity were excluded from the study.
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 |
|---|---|---|
| EvalationPost Covid Functional Scale (PCFS) was used to assess the functional status of the participants; Short Form- 36 (SF-36) questionnaire was used to assess quality of life; 30 s sit-to-stand test (30s-STS) and 6 min walk test (6 MWT) were used to assess functional capacity. | Other | S+, S- |
Primary outcome
Functional capacity, physical function, physical role difficulties, emotional role difficulties, pain and general health
Time frame: 1 year
Functional capacity was affected more in the group whose symptoms persisted than in the group whose symptoms did not persist (p<0.05). Some of the SF-36 sub-parameters (physical function, physical role difficulties, emotional role difficulties, pain and general health) were found to be sig-nificantly more affected in participants with persistent symptoms (p<0.05).
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 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COVID-19 Infection, run by Ziya Yildiz 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: finished, as of the sponsor's last update on 12 Feb 2025. 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?
Functional capacity, physical function, physical role difficulties, emotional role difficulties, pain and general health (time frame: 1 year). 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 Feb 2025.