- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06528145
Long Covid (Individuals with Ongoing COVID-19 Symptoms) Ongoing Effects (COVID-19)
February 10, 2025 updated by: Ziya Yildiz
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
70
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
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Isparta, Turkey, 32000
- Süleyman Demirel Univesity
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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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
S-
Individuals who have not had symptoms for 6-18 months after Covid infection
|
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.
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|
S+
Individuals with ongoing symptoms 6-18 months after Covid infection
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional capacity, physical function, physical role difficulties, emotional role difficulties, pain and general health
Time Frame: 1 year
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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).
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 25, 2021
Primary Completion (Actual)
December 2, 2022
Study Completion (Actual)
February 20, 2023
Study Registration Dates
First Submitted
July 29, 2024
First Submitted That Met QC Criteria
July 29, 2024
First Posted (Actual)
July 30, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 10, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Post-Infectious Disorders
- Pathologic Processes
- Chronic Disease
- Disease Attributes
- Respiratory Tract Infections
- Infections
- RNA Virus Infections
- Virus Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia, Viral
- Pneumonia
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- COVID-19
- Post-Acute COVID-19 Syndrome
Other Study ID Numbers
- SülDemirelUni_YildizA_002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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