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Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telerehabilitation
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis focused on measuring anxiety, depression, cystic fibrosis, caregiver, telerehabilitation

Eligibility Criteria

6 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Exercise group

    Control group

    Arm Description

    Patients in this group will attend telerehabilitation sessions.

    Patients in this arm will be subject to routine follow up.

    Outcomes

    Primary Outcome Measures

    Cystic fibrosis quality of life questtionaire
    Cystic fibrosis quality of life questtionaire

    Secondary Outcome Measures

    Full Information

    First Posted
    December 20, 2020
    Last Updated
    December 20, 2020
    Sponsor
    Marmara University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04683809
    Brief Title
    Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis
    Official Title
    The Effect of Telerehabilitation on Quality of Life, Anxiety and Depression Levels in Children With Cystic Fibrosis and Their Caregivers
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    May 2021 (Anticipated)
    Study Completion Date
    June 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cystic Fibrosis
    Keywords
    anxiety, depression, cystic fibrosis, caregiver, telerehabilitation

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise group
    Arm Type
    Experimental
    Arm Description
    Patients in this group will attend telerehabilitation sessions.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients in this arm will be subject to routine follow up.
    Intervention Type
    Other
    Intervention Name(s)
    Telerehabilitation
    Intervention Description
    Patients will attend rehabilitation sessions through online programmes for rehabilitation
    Primary Outcome Measure Information:
    Title
    Cystic fibrosis quality of life questtionaire
    Description
    Cystic fibrosis quality of life questtionaire
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ozge Kenis-Coskun
    Email
    ozgekenis@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis

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