NCT04583345

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

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

June 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

October 9, 2020

Last Update Submit

September 22, 2021

Conditions

Keywords

physical activityhypertensiveanxietyquality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 months

Secondary Outcomes (3)

  • Quality of Life Assesment

    2 months

  • Evaluation of Individuals Healthy Lifestyle Behaviors

    2 months

  • Anxiety and Depression Level

    2 months

Study Arms (2)

Hypertensive

Diagnosis of hypertension

Behavioral: Questionnaires

Healthy

Healthy blood pressure level and absence of any chronic disease

Behavioral: Questionnaires

Interventions

QuestionnairesBEHAVIORAL

Questionnaires: Physical therapists ask questions these assess quality of life, anxiety and depression, physical activity level.

HealthyHypertensive

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06230, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HypertensionSocial IsolationMotor ActivityAnxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSocial BehaviorBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ebru Calik Kutukcu, PhD

    Academic Staff

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 12, 2020

Study Start

June 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations