Clinical trial NCT05481190: The Impact Of A Tele-Exercise Program For Children With Cystic Fibrosis During The Covid-19 Pandemic On Quality Of Life
Official title: The Impact Of A Tele-Exercise Program For Children With Cystic Fibrosis During The Covid-19 Pandemic On Quality Of Life: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Exercise Addiction
Nursing Caries
Quality of Life
Exercise Adherence
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 34
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a randomized controlled experimental study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study was to examine the effect of the tele-exercise program applied to children with cystic fibrosis in the Covid-19 pandemic on the quality of life and the symptoms experienced during exercise

Detailed description: Cystic fibrosis is a chronic, progressive, life-shortening, genetic, complex disease that affects multiple organs and systems. The care and treatment process of cystic fibrosis disease requires a multidisciplinary approach. Regular exercise (as it is an important component of therapeutic treatment) improves respiratory function in children with cystic fibrosis. However, the treatment burden of the disease in the child and the serious respiratory system complications caused by the Covid-19 infection during the pandemic process cause patients with cystic fibrosis to be in the high risk group. Since it is thought that it is difficult for children with cystic fibrosis to exercise during the pandemic process, home exercise programs have gained importance. With the developing technology, patients are consulted remotely, training and consultancy services are provided and they can be followed continuously through phone calls and video conferences. Nurses are an important part of the multidisciplinary team responsible for the protection, development and maintenance of the health of the individual in every period of life. They have assumed the roles of educator, consultant, decision-maker, therapeutic, caregiver and researcher in order to protect the quality of life of children with exercise programs and to ensure that they lead an active life. In order for nurses to make exercise a part of the lives of children with cystic fibrosis, they should determine the knowledge level, awareness and needs of children and their families, and provide adequate and effective counseling so that they can meet their individual needs.

Eligibility criteria: Inclusion Criteria:

* Voluntary to participate in the study
* Getting consent from parents
* Being a child with cystic fibrosis between the ages of 10-18
* Having no psychological health problems
* No physical problems that would prevent the child from exercising"
* Computer/ owning a smart phone and being able to use these devices and having an internet connection at home".

Exclusion Criteria:

* Not participating in the exercise regularly (at least 2 times)",
* Not wanting to continue working out".
* Not being willing to participate in the study
* Not being able to get consent from their parents
* Being under the age of 10, over the age of 18 with a diagnosis of Cystic Fibrosis
* Having a psychological health problem
* Having a physical problem that prevents the child from exercising
* Using a computer/smartphone not having and not being able to use these devices
* Not having an internet connection at home".

Primary outcomes:
measure: changing the quality of life
timeFrame: Up to Six Weeks
measure: affects the symptoms
timeFrame: Up to Six Weeks
Secondary outcomes:
measure: changing the quality of life "Cystic Fibrosis Quality of Life Questionnaire"
timeFrame: Up to Six Weeks
measure: affects the symptoms during the tele-exercise
timeFrame: Up to Six Weeks
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
state: Atakum
Study officials:
References:
citation: Chen JJ, Cooper DM, Haddad F, Sladkey A, Nussbaum E, Radom-Aizik S. Tele-Exercise as a Promising Tool to Promote Exercise in Children With Cystic Fibrosis. Front Public Health. 2018 Sep 28;6:269. doi: 10.3389/fpubh.2018.00269. eCollection 2018.
citation: Cox NS, Alison JA, Button BM, Wilson JW, Holland AE. Feasibility and acceptability of an internet-based program to promote physical activity in adults with cystic fibrosis. Respir Care. 2015 Mar;60(3):422-9. doi: 10.4187/respcare.03165. Epub 2014 Nov 25.
citation: Quittner AL, Buu A, Messer MA, Modi AC, Watrous M. Development and validation of The Cystic Fibrosis Questionnaire in the United States: a health-related quality-of-life measure for cystic fibrosis. Chest. 2005 Oct;128(4):2347-54. doi: 10.1378/chest.128.4.2347.