Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis

December 20, 2020 updated by: Marmara University

The Effect of Telerehabilitation on Quality of Life, Anxiety and Depression Levels in Children With Cystic Fibrosis and Their Caregivers

Patients with cystic fibrosis aged 6-13 will be recruited and randomized into two groups: one will receive telerehabilitation sessions including postural, breathing and high-intensity interval training exercises and one will be subject to routine follow up. Exercise program will be applied three days a week for three months. Children will be assessed by pulmonary function tests, cystic fibrosis quality of life questionnaire, six minute walking test and anxiety and depression scale in children, while caregivers will be assessed by Beck depression scale and situational anxiety inventory.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with diagnosed cystic fibrosis

Exclusion Criteria:

  • Current pulmonary exacerbation
  • Musculoskeletal problems hinder exercising
  • No internet access
  • Patients and parents do not consent to intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise group
Patients in this group will attend telerehabilitation sessions.
Other: Telerehabilitation
Patients will attend rehabilitation sessions through online programmes for rehabilitation
No Intervention: Control group
Patients in this arm will be subject to routine follow up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cystic fibrosis quality of life questtionaire
Time Frame: 3 months
Cystic fibrosis quality of life questtionaire
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

December 20, 2020

First Submitted That Met QC Criteria

December 20, 2020

First Posted (Actual)

December 24, 2020

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 20, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1442

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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