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

July 23, 2020 updated by: Margarita Perez, Universidad Europea de Madrid

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Villaviciosa De Odón, Spain, 28670
        • Escuela de Doctorado e Investigacion, Universidad Europea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.
Experimental: Exercise-No NMES

This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.

The exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions.
Behavioral: Exercise-No NMES
Exercise-No NMES
Experimental: Exercise-NMES

This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.

The exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions. Additionally, this group will receive neuromuscular electrical stimulation (NMES) concomitant to the strength training.
Behavioral: Exercise-NMES
Exercise-NMES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Two assessment points throughout the study: baseline and 8 weeks after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cardiorespiratory Fitness
Time Frame: 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)
Two assessment points throughout the study:baseline and 8 weeks after the intervention
Changes in Pulmonary Function
Time Frame: Two assessment points throughout the study:baseline and 8 weeks after the intervention
Changes in pulmonary function will be measured using Spirometry
Two assessment points throughout the study:baseline and 8 weeks after the intervention
Changes in physical activity levels
Time Frame: 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)
Two assessment points throughout the study:baseline and 8 weeks after the intervention
Change in quality of life
Time Frame: 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)
Two assessment points throughout the study:baseline and 8 weeks after the intervention
Food consumption frequency
Time Frame: One assessment point at baseline:baseline and 8 weeks after the intervention
The food consumption frequency will be measured using food frequency questionnaire (FFQ)
One assessment point at baseline:baseline and 8 weeks after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Madrid

Investigators

  • Principal Investigator: Margarita Perez Ruiz, MD, Universidad Europea de Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2019

Primary Completion (Actual)

March 9, 2020

Study Completion (Actual)

March 9, 2020

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

November 3, 2019

First Posted (Actual)

November 6, 2019

Study Record Updates

Last Update Posted (Actual)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-0019/18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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