Comparison of Clinical Parameters in Individuals With Different Physical Activity Levels During the COVID-19 Pandemic Period

August 10, 2024 updated by: Elif Cansu Özkılıçaslan, Hacettepe University

Comparison of Balance, Exercise Capacity, Sleep Quality and Coronavirus Phobia in Individuals With Different Physical Activity Levels During the COVID-19 Pandemic Period

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.

Study Overview

Status

Completed

Conditions

Physical Activity

Detailed Description

In our study, the investigators aimed to compare balance, exercise capacity, sleep quality and coronavirus phobia levels and investigate the relationship between exercise capacity and balance in individuals with different physical activity levels during the COVID-19 pandemic period.

Materials and Methods of the Research:

The place of study: Cardiopulmonary Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation.

Time of the study: It is planned to collect data and write the study between February 2021 and February 2022.

Research Population, Sample, Research Group:

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).

Study Design:

Individuals meeting the inclusion criteria will be included in the study. The study will be conducted with people between the ages of 18-65 and whose local language is Turkish. A total of 64 participants, 32 inactive and 32 minimally/heavily active, will be included in the study.

Evaluations will be made using tele-assessment methods, not face-to-face due to the COVID-19 pandemic. Verbal informed consent will be obtained from all subjects by video interview method that they voluntarily participated in the study. Written informed consent will be obtained from the cases whose verbal consent has been obtained.

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Type

Observational

Enrollment (Actual)

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

Turkey
- - Ankara, Turkey, 06230
    - Hacettepe University

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
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise Capacity Time Frame: March,2021- August,2021	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 Time Frame: March,2021- August,2021	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 Time Frame: March,2021- August,2021	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 Time Frame: March,2021- August,2021	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 Time Frame: March,2021- August,2021	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 Time Frame: March,2021- August,2021	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 Time Frame: March,2021- August,2021	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

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)

March 27, 2021

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 10, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)