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
-
-
-
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. |
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. |
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
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
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.