Effects of Exercise With or Without Electrical Stimulation in Physical Fitness in Cystic Fibrosis: an Integrated Vision (ECOMIRIN Study)

Universidad Europea de Madrid1 site in 1 country27 target enrollmentJanuary 15, 2019

ConditionsCystic Fibrosis in Children

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cystic Fibrosis in Children
Sponsor: Universidad Europea de Madrid
Enrollment: 27
Locations: 1
Primary Endpoint: Change in Strength
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group.

Registry

clinicaltrials.gov

Start Date

January 15, 2019

End Date

March 9, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Universidad Europea de Madrid

Responsible Party

Principal Investigator

Margarita Perez

Full Professor in Exercise Physiology, MD, PhD

Universidad Europea de Madrid

Eligibility Criteria

Inclusion Criteria

•Diagnosis of CF
•Age: 6-18 years old
•Signature of informed consent of legal guardian and patient.

Exclusion Criteria

•Being a smoker
•Having had an exacerbation in the last 3 months
•Having undergone gastric surgery
•Having enteral nutrition at present
•The patients will come from the HIUNJ of Madrid.
•Currently taking CFTR modulators

Outcomes

Primary Outcomes

Change in Strength

Time Frame: Two assessment points throughout the study: baseline and 8 weeks after the intervention

Changes in strength will be measured using a five repetition maximum test (5RM)

Secondary Outcomes

Change in Cardiorespiratory Fitness(Two assessment points throughout the study:baseline and 8 weeks after the intervention)
Changes in Pulmonary Function(Two assessment points throughout the study:baseline and 8 weeks after the intervention)
Change in quality of life(Two assessment points throughout the study:baseline and 8 weeks after the intervention)
Changes in physical activity levels(Two assessment points throughout the study:baseline and 8 weeks after the intervention)
Food consumption frequency(One assessment point at baseline:baseline and 8 weeks after the intervention)