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Completed

NCT Number: NCT05481190

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Exercise Addiction Exercise Adherence Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Nursing Caries Pancreatic Diseases Quality of Life Respiratory Tract Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ondokuz Mayıs University

Samsun, Atakum, 55139, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

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.

just observation

Behavioral

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

Primary outcomes

  1. changing the quality of life

    Time frame: Up to Six Weeks

    changing the quality of life of children with cystic fibrosis after tele-exercise program

  2. affects the symptoms

    Time frame: Up to Six Weeks

    affects the symptoms experienced by the children in the tele-exercise group during exercise.

Secondary outcomes

  1. changing the quality of life "Cystic Fibrosis Quality of Life Questionnaire"

    Time frame: Up to Six Weeks

    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.

  2. affects the symptoms during the tele-exercise

    Time frame: Up to Six Weeks

    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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 1, 2022
Registry last updated
Dec 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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