Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis

Sponsor

Marmara University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04683809

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Other: Telerehabilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

May 1, 2021

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Cystic fibrosis quality of life questtionaire [3 months]
Cystic fibrosis quality of life questtionaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 13 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marmara University

ClinicalTrials.gov Identifier:

NCT04683809

Other Study ID Numbers:

1442

First Posted:

Dec 24, 2020

Last Update Posted:

Dec 24, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marmara University

Additional relevant MeSH terms:

Cystic Fibrosis

Fibrosis

Study Results

No Results Posted as of Dec 24, 2020