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

NCT05147285 | Completed

• 1 other identifier: KA-20069
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Cystic Fibrosis; Telerehabilitation

Keywords

exercise; oxidative stress; respiratory muscles

Outcome Measures

Primary Outcomes (4)

• six minute walk test distance

  Six-minute walk test distance is recorded

  before the exercise training

• six minute walk test distance

  Six-minute walk test distance is recorded

  eight week

• shuttle walk test distance

  shuttle walk test distance is recorded

  before exercise training

• shuttle walk test distance

  shuttle walk test distance is recorded

  eight week

Secondary Outcomes (60)

• Respiratory muscle strength

  before exercise training

• Respiratory muscle strength

  eight week

• Respiratory muscle endurance

  before exercise training

• Respiratory muscle endurance

  eight week

• Pulmonary functions-FVC

  before exercise training

Study Arms (3)

Stabilization group

EXPERIMENTAL

Only stabilization exercises in patients with cystic fibrosis

Other: stabilization exercises

combined group

EXPERIMENTAL

stabilization exercise and aerobic exercise training in patients with cystic fibrosis

Other: combined exercises

control group

EXPERIMENTAL

physical activity recommendations in patients with cystic fibrosis

Other: Physical activity recommendations

Interventions

stabilization exercises OTHER

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

Stabilization group

combined exercises 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.

combined group

Physical activity recommendations OTHER

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

control group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cystic Fibrosis; Motor Activity

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

Study Officials

• Deniz Dogru-Ersoz, Professor

  Hacettepe University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 31, 2021
• First Posted: December 7, 2021
• Study Start: October 22, 2020
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

TU (1)