Effects of Telerehabilitation-based Exercises in Cystic Fibrosis

NCT ID: NCT05590169

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-20
• Study Completion Date: 2024-06-30

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).

Conditions

Cystic Fibrosis; Exercise; Telerehabilitation; Exercise Capacity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I

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.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: OTHER

Group 1: Group exercises via Zoom application Group 2: Individual exercises via Zoom application Group 3: Routine treatment

Group 2

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.

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: OTHER

Group 1: Group exercises via Zoom application Group 2: Individual exercises via Zoom application Group 3: Routine treatment

Group 3

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exercise training

Group 1: Group exercises via Zoom application Group 2: Individual exercises via Zoom application Group 3: Routine treatment

Intervention Type: OTHER

Other Intervention Names

Telerehabilitation-based exercise

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: collaborator

Istanbul Bilgi University

OTHER

Sponsor Role: lead

Responsible Party

Cigdem Emirza

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Goksen Kuran Aslan, PT, phD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpasa

Istanbul, Istanbul, Turkey (Türkiye)

Istanbul Bilgi University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30324099 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36193006 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33511633 (View on PubMed)

Other Identifiers

05112022/96

Identifier Type: -

Identifier Source: org_study_id