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

NCT05481190 | Completed DMC

• 1 other identifier: Tele-Exercise
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Conditions

Cystic Fibrosis; Exercise Addiction; Nursing Caries; Quality of Life; Exercise Adherence

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• changing the quality of life "Cystic Fibrosis Quality of Life Questionnaire"

  Up to Six Weeks

• affects the symptoms during the tele-exercise

  Up to Six Weeks

Study Arms (2)

Tele-exercise program to Child with Cystic Fibrosis

EXPERIMENTAL

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; Behavioral: Just observation

Without exercise Child with Cystic Fibrosis

EXPERIMENTAL

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; Behavioral: Just observation

Interventions

Tele-Exercise Program BEHAVIORAL

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.

Tele-exercise program to Child with Cystic Fibrosis; Without exercise Child with Cystic Fibrosis

Just observation BEHAVIORAL

Standard care was given to the children in the control group.

Tele-exercise program to Child with Cystic Fibrosis; Without exercise Child with Cystic Fibrosis

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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".

You may not qualify if:

• 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".

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30324099 BACKGROUND

• 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.

  PMID: 25425703 BACKGROUND

• 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.

  PMID: 16236893 RESULT

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study is a randomized controlled experimental study.

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: April 1, 2021
• Primary Completion: September 15, 2021
• Study Completion: February 15, 2022
• Last Updated: December 20, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)