The Effects of Telerehabilitation on Muscle Function, Physical Activity and Sleep in Cystic Fibrosis During Pandemic

NCT04742049 | Completed

• 1 other identifier: KA-20058
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the peripheral muscle function, sleep disorders and physical activity level in children with cystic fibrosis who are physically inactive at home due to social isolation and to examine the effect of the 6-week online exercise protocol.

Conditions

Cystic Fibrosis; Covid19; Social Isolation

Keywords

exercise; sleep; cystic fibrosis

Outcome Measures

Primary Outcomes (3)

• 1 minute sit to stand test (STS) repetitions

  number of sit to stand for one minute is recorded

  before exercise training

• 1 minute sit to stand test (STS) repetitions

  number of sit to stand for one minute is recorded

  one month

• 1 minute sit to stand test (STS) repetitions

  number of sit to stand for one minute is recorded

  six week

Secondary Outcomes (16)

• sleep quality assessment

  before exercise training

• sleep quality assessment

  six week

• physical activity level

  before exercise training

• physical activity level

  six week

• crunch repetitions

  before exercise training

Study Arms (2)

Telerehabilitation

EXPERIMENTAL

Telerehabilitation based exercise training will be given to the study group.

Other: Telerehabilitation-based

Exercise brochure

EXPERIMENTAL

Exercise training will be provided by sending a document to the control group

Other: Follow-up based

Interventions

Telerehabilitation-based OTHER

15 pediatric cystic fibrosis patients who are at home during the self- isolation process due to the COVID-19 pandemic will be included in this group. Online exercise training protocol will be apply for patients. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks with a physiotherapist. Exercise protocol will start with the warm-up exercises and finish with cooling exercises.

Telerehabilitation

Follow-up based OTHER

15 pediatric cystic fibrosis patients who are at home during the self- isolation process due to the COVID-19 pandemic will be included in this group. An exercise document including the same exercise protocol in study group will be sent the patients. Patients will be called by the physiotherapist once a week for follow-up. .

Exercise brochure

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• People who diagnosed cystic fibrosis disease at stabile conditions.
• Volunteering to participate in the study,
• Having a social isolation due to COVID-19 pandemic
• Having forced expiratory volume at one second (FEV1) %\> 40 % at last 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.
• having a diagnosed with COVID-19 before or during the study
• Being physically or perceptually competent to exercise
• Patients with allergic bronchopulmonary aspergillosis (ABPA) who were treated with systemic steroid therapy
• Patients who were not complete the exercise training ability.
• 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; COVID-19; Social Isolation; 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; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Social Behavior; 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: January 17, 2021
• First Posted: February 5, 2021
• Study Start: December 28, 2020
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)