The Impact Of A Tele-Exercise Program For Children With Cystic Fibrosis During The Covid-19 Pandemic On Quality Of Life

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cystic Fibrosis; Exercise Addiction; Nursing Caries; Exercise Adherence
• Intervention / Treatment: Behavioral: Tele-Exercise Program; Behavioral: Just observation

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Atakum
    • Samsun, Atakum, Turkey, 55139
      • Ondokuz Mayıs University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-exercise program to Child with Cystic Fibrosis; Inclusion criteria were "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" and "Computer/ owning a smart phone and being able to use these devices", "Having an internet connection at home". The exclusion criteria were "Not volunteering to participate in the study", "Not being able to get consent from their parents", "Being under the age of 10 or 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" and "Not having a computer/smart phone and not being able to use these devices" and "Not having an internet connection at home". Exclusion criteria are "Not participating in the exercise regularly (at least 2 times)", "Not wanting to continue working out".	Behavioral: Tele-Exercise Program; Data collection tools were applied to the tele-exercise group and control group at the beginning of the study. For the tele-exercise group, by the researcher, Exp. A 6-week exercise program was created under the consultancy of a physiotherapist. Children who met the research criteria were asked to do these exercises for 20 minutes, 3 times a week for 6 weeks. The exercises were performed online with the researcher at the scheduled time one day a week, and by the children twice a week. On the days they exercised, diaries consisting of semi-structured questions were sent to the children's addresses by cargo and they were allowed to keep a diary. Phone calls were made once a week to provide motivation and increase compliance with exercise. A smart watch was sent to the children by cargo to increase motivation. The children were asked to fill in the follow-up form, which was sent via weekly google forms.; Behavioral: Just observation; Standard care was given to the children in the control group.
Experimental: Without exercise Child with Cystic Fibrosis; Inclusion criteria were "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" and "Computer/ owning a smart phone and being able to use these devices", "Having an internet connection at home". The exclusion criteria were "Not volunteering to participate in the study", "Not being able to get consent from their parents", "Being under the age of 10 or 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" and "Not having a computer/smart phone and not being able to use these devices" and "Not having an internet connection at home". Exclusion criteria are "Not participating in the exercise regularly (at least 2 times)", "Not wanting to continue working out".	Behavioral: Tele-Exercise Program; Data collection tools were applied to the tele-exercise group and control group at the beginning of the study. For the tele-exercise group, by the researcher, Exp. A 6-week exercise program was created under the consultancy of a physiotherapist. Children who met the research criteria were asked to do these exercises for 20 minutes, 3 times a week for 6 weeks. The exercises were performed online with the researcher at the scheduled time one day a week, and by the children twice a week. On the days they exercised, diaries consisting of semi-structured questions were sent to the children's addresses by cargo and they were allowed to keep a diary. Phone calls were made once a week to provide motivation and increase compliance with exercise. A smart watch was sent to the children by cargo to increase motivation. The children were asked to fill in the follow-up form, which was sent via weekly google forms.; Behavioral: Just observation; Standard care was given to the children in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changing the quality of life	changing the quality of life of children with cystic fibrosis after tele-exercise program	Up to Six Weeks
affects the symptoms	affects the symptoms experienced by the children in the tele-exercise group during exercise.	Up to Six Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changing the quality of life "Cystic Fibrosis Quality of Life Questionnaire"	The questionnaire prepared in a four-point likert type is scored according to frequency and difficulty level or whether the answers are correct or incorrect. It is thought that the higher the total score obtained from the questionnaire, the higher the health-related quality of life.	Up to Six Weeks
affects the symptoms during the tele-exercise	The children were asked to record their symptom findings daily and they were asked to share the recording documents with the researcher. In addition, the researcher questioned the symptom findings of the participants once a week by phone call and once a week via google form. The symptoms questioned through diary keeping, phone call and google form were recorded as symptom present/absent.	Up to Six Weeks

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): February 15, 2022

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 29, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

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: Tele-Exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: other researhers may view the study once it is published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No