NCT04988126

Brief Summary

The aim in this study is to evaluate pain, fatigue and quality of life in patients with Covid-19 pneumonia in long-term follow-up and to investigate their relationship with pneumonia severity, age, presence of comorbidity and depression level.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2022

Completed
Last Updated

August 12, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

July 29, 2021

Last Update Submit

August 6, 2021

Conditions

COVID-19 PneumoniaPainFatigueQuality of Life

Keywords

COVID-19 PneumoniaPainFatigueQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    Change from baseline visual analog scale (VAS) myalgia, arthralgia, cervical, thorocic and lumbar pain at 4th and 12th week. Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.

    up to 12th week

Secondary Outcomes (3)

  • Fatigue Severity Scale

    up to 12th week

  • Hospital Anxiety And Depression Scale

    up to 12th week

  • Short form 12 (SF-12)

    up to 12th week

Study Arms (1)

Patient Group

Patient with Covid 19 Pneumonia

Other: Interventions

Interventions

InterventionsOTHER

Observational study, not applicable

Patient Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients over the age of 18 who are hospitalized in the Pandemic Service, and are positive for COVID-19 PCR

You may qualify if:

  • Patient with Covid 19 Pneumonia

You may not qualify if:

  • Uncooperative Patient,
  • Illiterate Patients,
  • Pregnancy,
  • Patients with Chronic Pain or Fatigue in the last 6 months (before COVID-19 disease),
  • Patients who were admitted to the intensive care unit during their hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Cipollaro L, Giordano L, Padulo J, Oliva F, Maffulli N. Musculoskeletal symptoms in SARS-CoV-2 (COVID-19) patients. J Orthop Surg Res. 2020 May 18;15(1):178. doi: 10.1186/s13018-020-01702-w. No abstract available.

    PMID: 32423471BACKGROUND

  • Garrigues E, Janvier P, Kherabi Y, Le Bot A, Hamon A, Gouze H, Doucet L, Berkani S, Oliosi E, Mallart E, Corre F, Zarrouk V, Moyer JD, Galy A, Honsel V, Fantin B, Nguyen Y. Post-discharge persistent symptoms and health-related quality of life after hospitalization for COVID-19. J Infect. 2020 Dec;81(6):e4-e6. doi: 10.1016/j.jinf.2020.08.029. Epub 2020 Aug 25.

    PMID: 32853602BACKGROUND

  • Halpin SJ, McIvor C, Whyatt G, Adams A, Harvey O, McLean L, Walshaw C, Kemp S, Corrado J, Singh R, Collins T, O'Connor RJ, Sivan M. Postdischarge symptoms and rehabilitation needs in survivors of COVID-19 infection: A cross-sectional evaluation. J Med Virol. 2021 Feb;93(2):1013-1022. doi: 10.1002/jmv.26368. Epub 2020 Aug 17.

    PMID: 32729939BACKGROUND

MeSH Terms

Conditions

PainFatigue

Interventions

Methods

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Sevda MD ADAR

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

  • Ali İzzet MD AKÇİN

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali İzzet MD AKÇİN

CONTACT

+905469347374dr.akcin93@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant-MD

Study Record Dates

First Submitted

July 29, 2021

First Posted

August 3, 2021

Study Start

February 1, 2021

Primary Completion

October 1, 2021

Study Completion

February 15, 2022

Last Updated

August 12, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)