Effects of Telerehabilitation-based Exercises in Cystic Fibrosis

NCT05590169 | Completed

• 1 other identifier: 05112022/96
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

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

Keywords

physiotherapy; cystic fibrosis; randomized controlled trial; telerehabilitation

Outcome Measures

Primary Outcomes (2)

• Functional exercise capacity

  Six-minute walking test: Before the test, oxygen saturation, heart rate, blood pressure, dyspnea and fatigue measurements are recorded. The patient walks for six minutes as fast as they can walk on the ground for at least 30 meters. The walking distance is recorded in meters. If the patient stops during the test, the total time he stopped, the number of times he stopped is recorded. After the test, the evaluations made before the test are repeated.

  0-8 weeks

• Functional exercise capacity

  Modified shuttle walking test: It is a maximal test performed by adjusting walking speed with pre-recorded signals. Before the test, oxygen saturation, heart rate and blood pressure, dyspnea and fatigue will be recorded. The patient walks between two 10-meter points. Walking speed is increased every minute. The test is terminated when the required speed cannot be maintained or the speed cannot be followed. At the end of the test, the measurements are repeated.

  0-8 weeks

Secondary Outcomes (6)

• Muscle strength

  0-8 weeks

• Spirometric measurements

  0-8 weeks

• Balance

  0-8 weeks

• Anaerobic performance

  0-8 weeks

• Health-related quality of life by questionnaire

  0-8 weeks

Study Arms (3)

Group I

EXPERIMENTAL

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.

Other: Exercise training

Group 2

EXPERIMENTAL

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.

Other: Exercise training

Group 3

NO INTERVENTION

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

Interventions

Exercise training OTHER

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

Also known as: Telerehabilitation-based exercise

Group 2; Group I

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Bilgi University: lead
• Istanbul University - Cerrahpasa: collaborator

Study Sites (2)

Istanbul University-Cerrahpasa

Istanbul, Istanbul, 34500, Turkey (Türkiye)

Location

Istanbul Bilgi University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 30324099 BACKGROUND

• 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.

  PMID: 36193006 BACKGROUND

• 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.

  PMID: 33511633 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Goksen Kuran Aslan, PT, phD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 21, 2022
• Study Start: May 20, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: March 24, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)