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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cystic Fibrosis in Children

Intervention / Treatment
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* Behavioral: Exercise-NMES
* Behavioral: Exercise-No NMES


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cystic Fibrosis, Electrostimulation, Combined Training, Physical Fitness