PainCOVID-19NCT05808348
Effects of COVID-19 on the Elderly
An observational study of Pain and Fear, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Scales and questionnaires
- Type of treatment
- Vaccines
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2023to 11 May 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 65 years and older
- All sexes
- Older adult
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.
Who may be able to join
- Being 65 years or older
- Being cooperative
Who cannot join
- Refusing to participate in the study
- Having significant vision and hearing problems
- Not completing the study questions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of COVID-19 On Pain, Fear of Falling, Fall Frequency, and Physical Activity Level in the Elderly
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
- Being tested
- Scales and questionnaires
- Keywords
- COVID-19, Pain, Fear, Falling, Physical Activity, Aged
- Medical subject headings
- Pain, Motor Activity, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scales and questionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 Group | Demographic and clinical information, Numerical Pain Rating Scale, Falls Efficacy Scale International, Baecke Physical Activity Questionnaire Receives: Other: Scales and questionnaires | |
| Healthy Group | Demographic and clinical information, Numerical Pain Rating Scale, Falls Efficacy Scale International, Baecke Physical Activity Questionnaire Receives: Other: Scales and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Falling
Falls Efficacy Scale - International (total score between 16-64) (higher values indicate higher fear of falling)
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
Pain Regions and Pain Severity
Numerical Pain Rating Scale (total score between 0-10) (higher values indicate higher pain)
Measured: through study completion, an average of 6 months
Fall Frequency
Fall Frequency in 1 year
Measured: through study completion, an average of 6 months
Physical Activity Level
Baecke Physical Activity Questionnaire (total score between 3-15) (higher values indicate higher physical acitivity level)
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start2 Mar 2023
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozan Gür, PT, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808348
- Sponsor's protocol ID
- E-35523585-302.99-75492
- Acronym
- COVID-19
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 12 May 2023
- Results posted
- No
- 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 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of COVID-19 On Pain, Fear of Falling, Fall Frequency, and Physical Activity Level in the Elderly
- ClinicalTrials.gov ID
- NCT05808348
- Acronym / sponsor ID
- COVID-19 / E-35523585-302.99-75492
- Keywords
- COVID-19, Pain, Fear, Falling, Physical Activity, Aged
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 11 Apr 2023 (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.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 Group | – | Other: Scales and questionnairesDemographic and clinical information, Numerical Pain Rating Scale, Falls Efficacy Scale International, Baecke Physical Activity Questionnaire |
| Healthy Group | – | Other: Scales and questionnairesDemographic and clinical information, Numerical Pain Rating Scale, Falls Efficacy Scale International, Baecke Physical Activity Questionnaire |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
- 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.
Key inclusion criteria (2 listed)
- Being 65 years or older
- Being cooperative
Key exclusion criteria (3 listed)
- Refusing to participate in the study
- Having significant vision and hearing problems
- Not completing the study questions
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 |
|---|---|---|
| Scales and questionnairesWe 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. | Other | COVID-19 Group, Healthy Group |
Primary outcome
Fear of Falling
Time frame: through study completion, an average of 6 months
Falls Efficacy Scale - International (total score between 16-64) (higher values indicate higher fear of falling)
3 secondary outcomes
Pain Regions and Pain Severity
Time frame: through study completion, an average of 6 months
Fall Frequency
Time frame: through study completion, an average of 6 months
Physical Activity Level
Time frame: through study completion, an average of 6 months
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 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 Pain and Fear, run by Kırklareli 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 2 inclusion and 3 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 May 2023. 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 Falling (time frame: through study completion, an average of 6 months). 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 May 2023; AzTrials last refreshed its copy on 6 Nov 2026.