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

Primary Purpose

Cystic Fibrosis in Children

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exercise-NMES
Exercise-No NMES
Sponsored by
Universidad Europea de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis in Children focused on measuring Cystic Fibrosis, Electrostimulation, Combined Training, Physical Fitness

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Escuela de Doctorado e Investigacion, Universidad Europea

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Exercise-No NMES

Exercise-NMES

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Cardiorespiratory Fitness
Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Changes in Pulmonary Function
Changes in pulmonary function will be measured using Spirometry
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)
Change in quality of life
Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R)
Food consumption frequency
The food consumption frequency will be measured using food frequency questionnaire (FFQ)

Full Information

First Posted
October 30, 2019
Last Updated
July 23, 2020
Sponsor
Universidad Europea de Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT04153669
Brief Title
Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness
Acronym
ECOMIRIN
Official Title
Effects of Exercise With or Without Electrical Stimulation in Physical Fitness in Cystic Fibrosis: an Integrated Vision (ECOMIRIN Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
March 9, 2020 (Actual)
Study Completion Date
March 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis in Children
Keywords
Cystic Fibrosis, Electrostimulation, Combined Training, Physical Fitness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle.
Arm Title
Exercise-No NMES
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise-NMES
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise-NMES
Intervention Description
Exercise-NMES
Intervention Type
Behavioral
Intervention Name(s)
Exercise-No NMES
Intervention Description
Exercise-No NMES
Primary Outcome Measure Information:
Title
Change in Strength
Description
Changes in strength will be measured using a five repetition maximum test (5RM)
Time Frame
Two assessment points throughout the study: baseline and 8 weeks after the intervention
Secondary Outcome Measure Information:
Title
Change in Cardiorespiratory Fitness
Description
Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
Time Frame
Two assessment points throughout the study:baseline and 8 weeks after the intervention
Title
Changes in Pulmonary Function
Description
Changes in pulmonary function will be measured using Spirometry
Time Frame
Two assessment points throughout the study:baseline and 8 weeks after the intervention
Title
Changes in physical activity levels
Description
Changes in physical activity levels will be measured using Physical Activity Questionnaire for Children and Adolescents (PAC-C or PAC-A)
Time Frame
Two assessment points throughout the study:baseline and 8 weeks after the intervention
Title
Change in quality of life
Description
Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R)
Time Frame
Two assessment points throughout the study:baseline and 8 weeks after the intervention
Title
Food consumption frequency
Description
The food consumption frequency will be measured using food frequency questionnaire (FFQ)
Time Frame
One assessment point at baseline:baseline and 8 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarita Perez Ruiz, MD
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Escuela de Doctorado e Investigacion, Universidad Europea
City
Villaviciosa De Odón
ZIP/Postal Code
28670
Country
Spain

12. IPD Sharing Statement

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

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