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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04673331
Other study ID # GO 20/794
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2020
Est. completion date August 5, 2021

Study information

Verified date March 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study was to evaluate physical activity, exercise capacity, quality of life, cognitive status level and coronavirus phobia level of adult cystic fibrosis patients and compare with the findings of healthy subjects with teleconference during COVID-19 pandemic.


Description:

This study will be participated adult with cystic fibrosis and healthy individuals. Demographic information of individuals will be recorded in online video conference. Physical activity, exercise capacity and cognitive function levels will be measured during video conferencing.Then, the physical activity level, coronavirus phobia and quality of life of the participants will be evaluated subjectively with questionnaires through the Google forms.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 5, 2021
Est. primary completion date August 5, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Being over 18 years old Having the ability to access the internet through a device (computer or mobile device) that enables video conferencing Giving consent on a voluntary basis Exclusion Criteria: - Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
exercise capacity
3minute step test and 1minute sit to stand test used assessment of exercise capacity.

Locations

Country Name City State
Turkey Hacettepe University Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical Activity Level-International Physical Activity Questionnaire Physical activity level will be evaluated International Physical Activity Questionnaire- Short Form (IPAQ-SF). IPAQ short version asks spended time during sitting, walking, moderate and vigorous physical activities. The score is obtained by multiplying the minutes, days and metabolic equivalent values. According to these scores, physical activity levels are classified as "inactive", "minimally active" and "very active". 8 minutes
Primary Coronavirus Phobia-Coronavirus-19 Phobia Scale COVID-19 phobia will be evaluated with Coronavirus-19 Phobia Scale (C19P-S) and total score ranges from 20-100. Lower scores mean better outcome. 5 minutes
Primary Exercise Capacity Exercise capacity will be evaluated with 1-minute sit to stand test and 3-minute step test. Maximum heart rate, minimum saturation, count of step are record during the 3 minute step test. Number of sit to stand for 1 minute is recorded end of the 1 minute sit to stand test. 15 minutes
Primary Weekly Average Steps The number of steps in the last week was recorded and averaged using the pedometer applications from the participants own smartphones.
<5000 steps/day sedentary 5000-7499 steps/day low active 7500-9999 steps/day somewhat active
=10 000 steps/day active >12 500 steps/day highly active
2 minutes
Secondary Cognitive Function-Standardized Mini Mental State Examination Cognitive function evaluation will be Standardized Mini Mental State Examination (SMMSE). Scores less than 23 mean cognitive impairment. 5 minutes
Secondary Quality Of Life-Nottingham Health Profile Quality of life will be evaluated with Nottingham Health Profile (NHP). This questionnaire categorizes are energy, pain, emotional reactions, sleep, social isolation, physical mobility, depression and anxiety. Lower scores mean better outcome. 10 minutes
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