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

NCT04673331 | Completed

• 1 other identifier: GO 20/794
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Cognitive Function-Standardized Mini Mental State Examination

  5 minutes

• Quality Of Life-Nottingham Health Profile

  10 minutes

Study Arms (2)

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

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

Interventions

exercise capacity OTHER

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

Cystic fibrosis; Healthy individuals

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Severe comorbidity that limits mobilization or physical activity(orthopedic, cardiac or neurological condition) Pregnancy

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Naciye Vardar Yağlı, PhD

  Hacettepe University

  STUDY DIRECTOR

• Aydan Aslı Aksel

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Ebru Damadoğlu, PhD

  Hacettepe University

  STUDY CHAIR

• Merve Fırat, MSc

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: December 12, 2020
• First Posted: December 17, 2020
• Study Start: January 5, 2021
• Primary Completion: August 5, 2021
• Study Completion: August 5, 2021
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

TU (1)