Effects of a Telerehabilitation Approach in Children With Cystic Fibrosis
The Effect of Telerehabilitation on Quality of Life, Anxiety and Depression Levels in Children With Cystic Fibrosis and Their Caregivers
1 other identifier
interventional
30
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2020
CompletedFirst Posted
Study publicly available on registry
December 24, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedDecember 24, 2020
December 1, 2020
4 months
December 20, 2020
December 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cystic fibrosis quality of life questtionaire
Cystic fibrosis quality of life questtionaire
3 months
Study Arms (2)
Exercise group
EXPERIMENTALPatients in this group will attend telerehabilitation sessions.
Control group
NO INTERVENTIONPatients in this arm will be subject to routine follow up.
Interventions
Patients will attend rehabilitation sessions through online programmes for rehabilitation
Eligibility Criteria
You may qualify if:
- Patients with diagnosed cystic fibrosis
You may not qualify if:
- Current pulmonary exacerbation
- Musculoskeletal problems hinder exercising
- No internet access
- Patients and parents do not consent to intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2020
First Posted
December 24, 2020
Study Start
January 1, 2021
Primary Completion
May 1, 2021
Study Completion
June 1, 2021
Last Updated
December 24, 2020
Record last verified: 2020-12