HypertensionNCT04583345
Physical Activity Levels of Hypertensive and Healthy Individuals Under Social Isolation During the COVID-19 Pandemic
An observational study of Hypertension and Social Isolation, run by Ebru Calik Kutukcu at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Social Isolation, COVID
- What is being tested?
- Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Sep 2021
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension, Social Isolation, COVID
- Being tested
- Questionnaires
- Keywords
- physical activity, hypertensive, anxiety, quality of life
- Medical subject headings
- Hypertension, Social Isolation, Motor Activity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesBehavioural
Questionnaires: Physical therapists ask questions these assess quality of life, anxiety and depression, physical activity level.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive | Diagnosis of hypertension Receives: Behavioral: Questionnaires | |
| Healthy | Healthy blood pressure level and absence of any chronic disease Receives: Behavioral: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity
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.
Measured: 2 months
Secondary outcomes (3)
Quality of Life Assesment
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.
Measured: 2 months
Evaluation of Individuals Healthy Lifestyle Behaviors
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.
Measured: 2 months
Anxiety and Depression Level
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Jun 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ebru Calik Kutukcu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ebru Calik Kutukcu, Hacettepe University
- Investigators
- Ebru Calik Kutukcu, PhD, Principal investigator, Academic Staff
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583345
- Sponsor's protocol ID
- GO 20/610
- Status last verified
- Sep 2021
- First submitted
- 9 Oct 2020
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- 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 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Physical Activity Levels and Disease Attitudes of Hypertensive and Healthy Individuals Under Social Isolation During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04583345
- Acronym / sponsor ID
- GO 20/610
- Conditions
- Hypertension, Social Isolation, COVID
- Keywords
- physical activity, hypertensive, anxiety, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ebru Calik KutukcuUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 12 Oct 2020 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertensive | – | Behavioral: QuestionnairesDiagnosis of hypertension |
| Healthy | – | Behavioral: QuestionnairesHealthy blood pressure level and absence of any chronic disease |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| QuestionnairesQuestionnaires: Physical therapists ask questions these assess quality of life, anxiety and depression, physical activity level. | Behavioural | Healthy, Hypertensive |
Primary outcome
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.
3 secondary outcomes
Quality of Life Assesment
Time frame: 2 months
Evaluation of Individuals Healthy Lifestyle Behaviors
Time frame: 2 months
Anxiety and Depression Level
Time frame: 2 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 23 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Ebru Calik Kutukcu, PhD principal investigator
Academic Staff
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 Hypertension and Social Isolation, run by Ebru Calik Kutukcu 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 4 inclusion and 4 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 23 Sep 2021. 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?
Physical Activity (time frame: 2 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 23 Sep 2021.