Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04153669

Acronym

ECOMIRIN

Enrollment

Registered

2019-11-06

Start date

2019-01-15

Completion date

2020-03-09

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis in Children

Keywords

Cystic Fibrosis, Electrostimulation, Combined Training, Physical Fitness

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.

Interventions

BEHAVIORALExercise-NMES

Exercise-NMES

BEHAVIORALExercise-No NMES

Exercise-No NMES

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Strength	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

Measure	Time frame	Description
Change in Cardiorespiratory Fitness	Two assessment points throughout the study:baseline and 8 weeks after the intervention	Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Changes in Pulmonary Function	Two assessment points throughout the study:baseline and 8 weeks after the intervention	Changes in pulmonary function will be measured using Spirometry
Changes in physical activity levels	Two assessment points throughout the study:baseline and 8 weeks after the intervention	Changes in physical activity levels will be measured using Physical Activity Questionnaire for Children and Adolescents (PAC-C or PAC-A)
Change in quality of life	Two assessment points throughout the study:baseline and 8 weeks after the intervention	Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R)
Food consumption frequency	One assessment point at baseline:baseline and 8 weeks after the intervention	The food consumption frequency will be measured using food frequency questionnaire (FFQ)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026