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Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis

NCT ID: NCT04683809

Last Updated: 2020-12-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2021-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Keywords

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anxiety depression cystic fibrosis caregiver telerehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise group

Patients in this group will attend telerehabilitation sessions.

Group Type EXPERIMENTAL

Telerehabilitation

Intervention Type OTHER

Patients will attend rehabilitation sessions through online programmes for rehabilitation

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Telerehabilitation

Patients will attend rehabilitation sessions through online programmes for rehabilitation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Ozge Kenis-Coskun

Role: CONTACT

Email: [email protected]

Other Identifiers

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1442

Identifier Type: -

Identifier Source: org_study_id