Clinical trial NCT05590169: Effects of Telerehabilitation-based Exercises in Cystic Fibrosis
Official title: Comparison of Effects of Telerehabilitation-based Individual and Group Exercises on Functional Capacity in Patients with Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Exercise
Telerehabilitation
Exercise Capacity
Keywords: physiotherapy
cystic fibrosis
randomized controlled trial
telerehabilitation
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2022-10-21
Enrollment: 45
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pulmonary rehabilitation programs are an important part of lifelong therapy in the treatment of patients with cystic fibrosis. Although the possible benefits of exercise are known, physical activity levels and participation in exercise are low in patients with cystic fibrosis. There are barriers such as lack of time, demoralization, lack of motivation, and transportation problems. Although group exercises are an approach that increases participation and motivation, it is not considered a very suitable method because it increases the risk of cross infection in patients with cystic fibrosis when performed face-to-face. Telerehabilitation programs, which are increasingly used in chronic respiratory diseases, show similar results with clinical rehabilitation programs. Telerehabilitation programs, the effects of which have been examined in different disease groups in recent years, on patients with cystic fibrosis are limited in the literature. Group exercises that can be given with the telerehabilitation method may be a good approach for patients with cystic fibrosis, eliminating possible infection transmission.

The goal of this interventional clinical trial is to compare of effects of telerehabilitation based individual and group exercises on functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic power, quality of life, and adherence in children with cystic fibrosis. The main question it aims to answer are:

• Is there a difference between functional exercise capacity, muscle strength, respiratory functions, balance, anaerobic performance, quality of life and compliance with treatment between telerehabilitation based group exercises and telerehabilitation based individual exercises in patients with cystic fibrosis?

Participants will be randomized into three groups:

Group 1: They will be divided into groups of four and included in the exercise training for eight weeks with telerehabilitation.

Group 2: They will be individually included in exercise training with telerehabilitation for eight weeks.

Group 3 (control group): They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with cystic fibrosis
* Being between the ages of 8-18
* Having a device for video calls (phone, computer, tablet, etc.)

Exclusion Criteria:

* Severe airway obstruction (FEV1 (%, predicted) \<40%)
* Pulmonary exacerbation/hospitalization in the last four weeks
* History of lung transplant
* Orthopedic problems that limit exercise
* Those who had a change in their medical treatment during the study

Primary outcomes:
measure: Functional exercise capacity
timeFrame: 0-8 weeks
measure: Functional exercise capacity
timeFrame: 0-8 weeks
Secondary outcomes:
measure: Muscle strength
timeFrame: 0-8 weeks
measure: Spirometric measurements
timeFrame: 0-8 weeks
measure: Balance
timeFrame: 0-8 weeks
measure: Anaerobic performance
timeFrame: 0-8 weeks
measure: Health-related quality of life by questionnaire
timeFrame: 0-8 weeks
measure: Adherence rate
timeFrame: When the exercise training is over (after eight weeks)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
city: Istanbul
country: Turkey
facility: Istanbul Bilgi University
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Goksen Kuran Aslan, PT, phD
role: STUDY_DIRECTOR
References:
citation: Chen JJ, Cooper DM, Haddad F, Sladkey A, Nussbaum E, Radom-Aizik S. Tele-Exercise as a Promising Tool to Promote Exercise in Children With Cystic Fibrosis. Front Public Health. 2018 Sep 28;6:269. doi: 10.3389/fpubh.2018.00269. eCollection 2018.
citation: Stanford G, Daniels T, Brown C, Ferguson K, Prasad A, Agent P, Gates A, Morrison L. Role of the Physical Therapist in Cystic Fibrosis Care. Phys Ther. 2022 Dec 30;103(1):pzac136. doi: 10.1093/ptj/pzac136.
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.