- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04583345
Physical Activity Levels of Hypertensive and Healthy Individuals Under Social Isolation During the COVID-19 Pandemic
September 22, 2021 updated by: Ebru Calik Kutukcu
Comparison of Physical Activity Levels and Disease Attitudes of Hypertensive and Healthy Individuals Under Social Isolation During the COVID-19 Pandemic
COVID-19 is an emergency situation which broke out from China in 2020.
Health commitees and goverment set some rules and limit people's freedom to leave from their houses and it is called as 'social isolation'.Staying at home and disease bring about sedentary lifestyle, anxiety and depression and changed eating habits of all person.
Hypertension is an important cardiovasculary risk factor and physical activity, stress managament are very important for disease control.
In that study we aimed to assess hypertensive and healthy person's anxiety level, physical activity and qualit of life level during COVID-19 social isolation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
COVID-19 is an emergency situation which broke out from China in 2020.
Health commitees and goverment set some rules and limit people's freedom to leave from their houses and it is called as 'social isolation'.
With social isolation people were restricted to go outside from house and with that they had to stay at home.
Staying at home and disease bring about sedentary lifestyle, anxiety and depression and changed eating habits of all person.
It was very dangerous especially chronically ill persons.
Physical activity and exercise are keystones for managing cardiovasculary disease risk factors.
Hypertension is important risk factor all around the world.
Disease control is important to prevent complications.
In that study, we aimed to assess hypertensive and healhty individuals' physical activity, anxiety, healthy lifestyle habits and quality of life with changed life condition during COVID-19 social isolation.
Study Type
Observational
Enrollment (Actual)
80
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
-
-
-
Ankara, Turkey, 06230
- Hacettepe University
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-
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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy population: Being adult and absence of any chronic disease and willing to participate to study
Hypertensive Population: Diagnosed with hypertension, being adult and willing to participate study
Description
Inclusion Criteria:
- Social and occupational restriction because of COVID-19 pandemic
- Not having speech and hearing problems
- To be cooperate
- Not having mental, neurological, orthopedic, cardiovascular or pulmonary problems that prevent physical activity
Exclusion Criteria:
- Presence of medical indications requiring complete restriction of physical activity
- Having symptoms of COVID-19 and suspected disease
- Coronavirus infection in the past month
- Concomitant history of cardiovascular disease
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hypertensive
Diagnosis of hypertension
|
Questionnaires: Physical therapists ask questions these assess quality of life, anxiety and depression, physical activity level.
|
|
Healthy
Healthy blood pressure level and absence of any chronic disease
|
Questionnaires: Physical therapists ask questions these assess quality of life, anxiety and depression, physical activity level.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical Activity
Time Frame: 2 months
|
Physical activity level assessed with International Physical Activity Questionnaire (IPAQ) long version.
IPAQ long version asks work-related, transport, domestic and recreational physical activities.
It categorizes physical activities vigorous, moderate and walking.
It uses frequency and duration of activities.
Every physical activity category has a point and better physical activity level is related with higher IPAQ scores.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life Assesment
Time Frame: 2 months
|
It will assess with Short form 36 questionnaire.
It assesses quality of life and it contains different parameters for example body function, pain, physical and mental health etc.
Each subscale is evaluated between 0-100 points.
A higher score indicates the better health.
|
2 months
|
|
Evaluation of Individuals Healthy Lifestyle Behaviors
Time Frame: 2 months
|
Healthy lifestyle behavior will asssess with Healthy Life Style Behavior Scale.
The reliability and validity of the scale has been studied in Turkey.
The lowest score that can be obtained from these three sub-dimensions is 26 and the highest score that can be obtained is 104.Positivite healthy lifestyles related with higher scores.
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2 months
|
|
Anxiety and Depression Level
Time Frame: 2 months
|
Hospital Anxiety and Depression Scale (HADS) will use.The HADS contains fourteen item.
Seven of the items relate to anxiety and seven relate to depression.
The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ebru Calik Kutukcu, PhD, Academic Staff
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)
June 1, 2020
Primary Completion (Actual)
September 1, 2021
Study Completion (Actual)
September 1, 2021
Study Registration Dates
First Submitted
October 9, 2020
First Submitted That Met QC Criteria
October 9, 2020
First Posted (Actual)
October 12, 2020
Study Record Updates
Last Update Posted (Actual)
September 23, 2021
Last Update Submitted That Met QC Criteria
September 22, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GO 20/610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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