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

NCT ID: NCT04153669

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-03-09

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.

Detailed Description

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Conditions

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Cystic Fibrosis in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Exercise-No NMES

Intervention Type BEHAVIORAL

Exercise-No NMES

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.

Group Type EXPERIMENTAL

Exercise-NMES

Intervention Type BEHAVIORAL

Exercise-NMES

Interventions

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Exercise-NMES

Exercise-NMES

Intervention Type BEHAVIORAL

Exercise-No NMES

Exercise-No NMES

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Europea de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Margarita Perez

Full Professor in Exercise Physiology, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margarita Perez Ruiz, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea de Madrid

Locations

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Escuela de Doctorado e Investigacion, Universidad Europea

Villaviciosa de Odón, , Spain

Site Status

Countries

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Spain

Other Identifiers

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R-0019/18

Identifier Type: -

Identifier Source: org_study_id

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