NCT05808348

Brief Summary

The goal of this observational study is to learn about in former COVID-19 patients. The main questions it aims to answer are:

  • are there any association among pain, fear of falling, fall frequency, and physical activity level
  • are there any difference between former COVID-19 elders and non-COVID-19 elderly population

Trial Health

87
On Track

Trial Health Score

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

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 2, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2023

Completed
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

April 7, 2023

Last Update Submit

May 11, 2023

Conditions

Keywords

COVID-19PainFearFallingPhysical ActivityAged

Outcome Measures

Primary Outcomes (1)

  • Fear of Falling

    Falls Efficacy Scale - International (total score between 16-64) (higher values indicate higher fear of falling)

    through study completion, an average of 6 months

Secondary Outcomes (3)

  • Pain Regions and Pain Severity

    through study completion, an average of 6 months

  • Fall Frequency

    through study completion, an average of 6 months

  • Physical Activity Level

    through study completion, an average of 6 months

Study Arms (2)

COVID-19 Group

Demographic and clinical information, Numerical Pain Rating Scale, Falls Efficacy Scale International, Baecke Physical Activity Questionnaire

Other: Scales and questionnaires

Healthy Group

Demographic and clinical information, Numerical Pain Rating Scale, Falls Efficacy Scale International, Baecke Physical Activity Questionnaire

Other: Scales and questionnaires

Interventions

We will ask participants about their age, gender, height, weight, education level, medical history, number of falls in the last 1 year, status and length of COVID-19-related hospitalizations, and whether they have gotten the COVID-19 vaccine. The participants will be interviewed in person as part of the evaluation process. The Modified Baecke Physical Activity Questionnaire, the Fall Efficacy Scale-International, and the Numerical Pain Rating Scale will be used to assess the participants' levels of pain, fear of falling, and physical activity, respectively.

COVID-19 GroupHealthy Group

Eligibility Criteria

Age65 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be carried out with people aged 65 and over living in Kırklareli/Turkey. Individuals will be divided into 2 groups as the COVID-19 group and the control group, according to whether they have had COVID-19 infection in the last 1 year.

You may qualify if:

  • Being 65 years or older
  • Being cooperative

You may not qualify if:

  • Refusing to participate in the study
  • Having significant vision and hearing problems
  • Not completing the study questions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırklareli University

Kırklareli, 39000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainMotor ActivityCOVID-19

Interventions

Weights and MeasuresSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Investigative TechniquesData CollectionEpidemiologic MethodsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 7, 2023

First Posted

April 11, 2023

Study Start

March 2, 2023

Primary Completion

May 11, 2023

Study Completion

May 11, 2023

Last Updated

May 12, 2023

Record last verified: 2023-05

Locations