Physical Activity, Exercise Capacity and Coronavirus Phobia of Adult Cystic Fibrosis Patients During COVID-19 Pandemic

Comparison of Physical Activity, Exercise Capacity, Quality of Life, Cognitive Function and Coronavirus Phobia Levels of Adult Cystic Fibrosis Patients With Healthy Individuals With Telerehabilitation in the COVID-19 Pandemic

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.

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: exercise capacity

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Hacettepe University

Participation Criteria

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: Non-Probability Sample

Study Population

Patients and healthy individuals between 18-65 years old, who are diagnosed with cystic fibrosis will be included in the study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cystic fibrosis; Inclusion Criteria: Having been diagnosed with cystic fibrosis Being over 18 years old The clinical condition is stable 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	Other: exercise capacity; 3minute step test and 1minute sit to stand test used assessment of exercise capacity.
Healthy individuals; 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	Other: exercise capacity; 3minute step test and 1minute sit to stand test used assessment of exercise capacity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Study Director: Naciye Vardar Yağlı, PhD, Hacettepe University; Principal Investigator: Aydan Aslı Aksel, Hacettepe University; Study Chair: Ebru Damadoğlu, PhD, Hacettepe University; Study Chair: Merve Fırat, MSc, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2020
• Primary Completion (Actual): August 5, 2021
• Study Completion (Actual): August 5, 2021

Study Registration Dates

• First Submitted: December 12, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; COVID-19; Cystic Fibrosis
• Other Study ID Numbers: GO 20/794

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