Effects of Telerehabilitation-based Exercises in Cystic Fibrosis

Istanbul Bilgi University

Status: Completed

Conditions: Telerehabilitation; Exercise Capacity; Cystic Fibrosis; Exercise

Treatments: Other: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05590169

05112022/96

Details and patient eligibility

About

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).

Enrollment: 45 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Group I

Experimental group

Description:

They will be included in exercise training as a group (three or four participants) with telerehabilitation (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar Unite Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter.

Treatment:

Other: Exercise training

Group 2

Experimental group

Description:

They will be individually included in exercise training with (via Zoom application) for eight weeks. Exercise program includes: (F) 3 times a week, (I) at 60-70% of the maximum heart rate, (T): breathing, stretching, aerobic, plyometric, balance exercises, (T) 30 minutes each session, a total of 8 week. During the exercise sessions, the heart rate will be monitored via a Polar Unite Fitness Watch, and the oxygen saturations will be monitored with a pulse oximeter.

Treatment:

Other: Exercise training

Group 3

No Intervention group

Description:

They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).