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NCT04153669 Clinical Trial

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

Cystic Fibrosis in Children Clinical Trial

— ECOMIRIN  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04153669
Other study ID # R-0019/18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2019
Est. completion date March 9, 2020

Study information
Verified date July 2020
Source Universidad Europea de Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date March 9, 2020
Est. primary completion date March 9, 2020
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Exercise-NMES
Exercise-NMES
• Exercise-No NMES
Exercise-No NMES

Locations
Country Name City State
Spain Escuela de Doctorado e Investigacion, Universidad Europea Villaviciosa De Odón

Sponsors (1)
Lead Sponsor Collaborator
Universidad Europea de Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Strength Changes in strength will be measured using a five repetition maximum test (5RM) Two assessment points throughout the study: baseline and 8 weeks after the intervention
Secondary Change in Cardiorespiratory Fitness Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET) Two assessment points throughout the study:baseline and 8 weeks after the intervention
Secondary Changes in Pulmonary Function Changes in pulmonary function will be measured using Spirometry Two assessment points throughout the study:baseline and 8 weeks after the intervention
Secondary Changes in physical activity levels Changes in physical activity levels will be measured using Physical Activity Questionnaire for Children and Adolescents (PAC-C or PAC-A) Two assessment points throughout the study:baseline and 8 weeks after the intervention
Secondary Change in quality of life Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R) Two assessment points throughout the study:baseline and 8 weeks after the intervention
Secondary Food consumption frequency The food consumption frequency will be measured using food frequency questionnaire (FFQ) One assessment point at baseline:baseline and 8 weeks after the intervention
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