NCT06551025

Brief Summary

The COVID-19 pandemic started in China towards the end of 2019 and soon affected the whole world. Restriction and isolation measures have been taken to prevent the spread of this disease caused by a new type of coronavirus, coronavirus-2. These measures have changed people's physical activity levels and have also affected other parameters that physical activity affects. This study aims comparison of clinical parameters in with different physical activity levels during the COVID-19 pandemic period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2021

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 27, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 9, 2024

Last Update Submit

August 10, 2024

Conditions

Keywords

adultexercisesleepCOVID-19

Outcome Measures

Primary Outcomes (7)

  • Exercise Capacity

    The 1 minute sit-to-stand test is one of the tests that evaluates exercise capacity.In this test, the number of sitting and standing repetitions in a chair for 1 minute is recorded. Heart rate, shortness of breath, and fatigue perceptions will be recorded before and after the test.

    March,2021- August,2021

  • Physical Activity

    The International Physical Activity Questionnare (IPAQ)- Short form assesses the level of physical activity.The short form consists of seven questions. It provides information on sitting, walking, moderately vigorous activities, and time spent in vigorous activities.

    March,2021- August,2021

  • Cognitive Function

    The standardized mini mental test is a test that evaluates the suitability of individuals' cognitive functions for tele-assessment. It consists of eleven items gathered under five main headings: orientation, recording memory, attention and calculation, recall and language.

    March,2021- August,2021

  • Coronavirus Phobia

    The Coronavirus 19 Phobia Scale (C19P-S) is a scale that evaluates coronavirus phobia. C19P-S is a five-point Likert-type self-assessment scale developed to measure phobia against coronavirus. The test has psychological, somatic, social and economic sub-dimensions.

    March,2021- August,2021

  • Sleep Quality

    The Pittsburgh Sleep Quality Scale (PSQI) is one of the scales that evaluates sleep quality. PSQI is a self-reported screening and evaluation test that provides information about the type and severity of sleep quality disturbances and sleep structure problems.

    March,2021- August,2021

  • Health Literacy

    Turkish Health Literacy Scale-32 (TSOY-32) is a scale consisting of 32 questions and evaluating health literacy. The scale, based on the conceptual framework developed by the European Health Literacy Research Consortium, was developed by Okyay et al. to assess health literacy among literate people over the age of 15.

    March,2021- August,2021

  • Balance

    Berg Balance Scale is a scale used to evaluate dynamic and static balance skills. It consists of 14 activities that require balance skills in different positions such as standing, sitting, and standing on one leg.

    March,2021- August,2021

Study Arms (2)

Inactive

Individuals with physical activity levels of 0-600 METs according to the results of the International Physical Activity Scale (IPAQ).

Minimally/Heavily active

Individuals with physical activity levels of 600-3000 METs or 3000 METs and above according to the results of the International Physical Activity Scale (IPAQ).

Eligibility Criteria

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

The population of the study is healthy individuals whose physical activity level was determined according to the results of the International Physical Activity Questionnare (IPAQ). The sample of the study is healthy individuals whose physical activity level is inactive and minimally/heavily active according to the results of the International Physical Activity Questionnare (IPAQ).

You may qualify if:

  • Being between the ages of 18-65
  • Being able to cooperate with the tests
  • Not have any known acute or chronic health problems that may prevent them from performing the tests or affect the test performance.
  • Not having any known acute or chronic disease that may affect the balance status.
  • Not having orthopedic, neurological and serious cardiovascular problems that will affect the performance of the sit-stand test for 1 minute
  • Volunteering to participate in the study
  • Having access to a phone or video conferencing platform with a reliable internet connection with their own device
  • To have the ability to operate these devices independently or with the help of another individual
  • Have adequate hearing function and language knowledge
  • Be able to move independently and safely even with walking aid

You may not qualify if:

  • Not cooperating with the tests
  • Known information that may prevent it from performing tests or affect test performance have acute and chronic health problems
  • Known acute and chronic illness that may affect balance
  • Have angina and ischemic heart disease onset at rest or with minimal effort
  • Have a cognitive impairment
  • Risk of falling and having poor balance Not having access to a phone or video conferencing platform with a reliable internet connection with their own device
  • Not having sufficient hearing function and language knowledge
  • Not being able to move independently and safely even with walking aid
  • Not being willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityCOVID-19

Condition Hierarchy (Ancestors)

BehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

March 27, 2021

Primary Completion

August 30, 2021

Study Completion

August 30, 2021

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations