Comparison of Effects of Telerehabilitation-based Individual and Group Exercises on Functional Capacity in Patients with Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Istanbul Bilgi University
- Enrollment
- 45
- Locations
- 4
- Primary Endpoint
- Functional exercise capacity
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group 3
They will continue their routine treatment (medical treatment, airway cleaning techniques, physical activity counseling).
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.
Intervention: Exercise training (Other)
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.
Intervention: Exercise training (Other)
Outcomes
Primary Outcomes
Functional exercise capacity
Time Frame: 0-8 weeks
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.
Secondary Outcomes
- Muscle strength(0-8 weeks)
- Balance(0-8 weeks)
- Spirometric measurements(0-8 weeks)
- Anaerobic performance(0-8 weeks)
- Health-related quality of life by questionnaire(0-8 weeks)
- Adherence rate(When the exercise training is over (after eight weeks))
Investigators
Cigdem Emirza
Research Assistant
Istanbul Bilgi University