The Effect of Telerehabilitation on Functional Capacity, Oxidative Stress and Respiratory Parameters in Cystic Fibrosis

NCT ID: NCT05147285

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-22
• Study Completion Date: 2022-05-20

Brief Summary

The aim of this study is to examine the effects of different exercise modalities applied with tele-rehabilitation on functional capacity, oxidative stress and respiratory parameters in children with cystic fibrosis

Detailed Description

Cystic fibrosis (CF) is the most common life-shortening autosomal recessive disease among populations of caucasians with a frequency of 1 in 2000 to 3000 live births. The most common problems in these patients are increased bronchial secretion, decreased exercise capacity, and shortness of breath. In addition to progressive respiratory disease, peripheral and respiratory muscle function impairments, inflammation, and contribute to the decrease in exercise capacity in CF patients. Recent studies show that increased oxidative stress and impaired oxidant / antioxidant capacity have an important role in disease progression in CF patients. CF childrens may be more physically inactive. Cystic fibrosis transmembrane regulator (CFTR) modulators, airway clearance therapies, chest physiotherapy and exercise trainings are treatment options in these populations. Regular exercise which is the component of pulmonary rehabilitation (PR), is recommended for patients with CF. Aerobic exercise may help to mobilize secretions, in addition to providing the other known benefits of exercise in healthy individuals. Despite the benefits of PR programmes, low participant uptake, high drop-out rates, financial and transportation difficulties reduced the attendance in these programs. Different telemedicine treatments have been developed to overcome these difficulties and reduce healthcare costs. In recent studies, shows that tele-exercise is a promising new approach to promote exercise in children with CF. Although different exercise modalities such as aerobic exercise training and strength training have been investigated in CF patients, there is no study to examine stabilization exercises in this populations. Also there is no study to evaluate the effect of exercise training on irisin. In addition, although it is known that acute exercise has positive effects on both oxidant and antioxidant markers in the pediatric population, the effect of long-term exercise on oxidative stress has not been adequately studied. The aim of this study is to examine the effect of different exercise training modalities applied with telerehabilitation method on functional capacity, oxidative stress and respiratory parameters in CF patients. . In the study, after measuring respiratory functions, exercise capacity, oxidative stress parameters, peripheral muscle functions, balance, posture, quality of life and physical activity questionnaire, 39 people will be divided into three groups. First group will be applied only online supervised stabilization exercises, Second group will be applied online supervised aerobic exercise training and stabilization exercises. And the third group, the physical activity importance will be explained and appropriate physical activity recommendations will be made. All outcome measures will be repeated after exercise training.

Conditions

Cystic Fibrosis; Telerehabilitation

Study Design

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

Study Groups

Stabilization group

Only stabilization exercises in patients with cystic fibrosis

Group Type: EXPERIMENTAL

stabilization exercises

Intervention Type: OTHER

Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.

combined group

stabilization exercise and aerobic exercise training in patients with cystic fibrosis

Group Type: EXPERIMENTAL

combined exercises

Intervention Type: OTHER

Patients will be applied online supervised aerobic exercise training and stabilization exercises.Aerobic exercises will be performed for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week, on the days when stabilization exercises are not performed.

control group

physical activity recommendations in patients with cystic fibrosis

Group Type: EXPERIMENTAL

Physical activity recommendations

Intervention Type: OTHER

The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.

Interventions

stabilization exercises

Patients will be applied only online supervised stabilization exercises three times a week for 8 weeks.

Intervention Type: OTHER

combined exercises

Patients will be applied online supervised aerobic exercise training and stabilization exercises.Aerobic exercises will be performed for 8 weeks, for 30-45 minutes, at 65-75% of the maximum heart rate, 3 days a week, on the days when stabilization exercises are not performed.

Intervention Type: OTHER

Physical activity recommendations

The importance of physical activity will be explained to the patients and appropriate physical activity recommendations will be made.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients aged 8-18 years with a diagnosis of cystic fibrosis (CF)
• Access to online exercise training
• Percent predicted of forced expiratory volume at one second (FEV1) > 40% in pulmonary function test

Exclusion Criteria

• Being diagnosed with acute pulmonary exacerbation at the time of study and / or within the last month.
• Being physically or perceptually competent to exercise
• Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy
• Having FEV1 %< 40% at pulmonary function test.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Kübra Kılıç

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deniz Dogru-Ersoz, Professor

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Locations

Hacettepe University

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KA-20069

Identifier Type: -

Identifier Source: org_study_id