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

NCT ID: NCT05481190

Last Updated: 2023-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-02-15

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis Exercise Addiction Nursing Caries Quality of Life Exercise Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a randomized controlled experimental study.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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".

Group Type EXPERIMENTAL

Tele-Exercise Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

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".

Group Type EXPERIMENTAL

Tele-Exercise Program

Intervention Type 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

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Just observation

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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".
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ondokuz Mayıs University

OTHER

Sponsor Role lead

Responsible Party

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Merve Koyun

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ondokuz Mayıs University

Samsun, Atakum, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30324099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25425703 (View on PubMed)

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.

Reference Type RESULT
PMID: 16236893 (View on PubMed)

Other Identifiers

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Tele-Exercise

Identifier Type: -

Identifier Source: org_study_id