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

European University

Status: Completed

Conditions: Cystic Fibrosis in Children

Treatments: Behavioral: Exercise-No NMES; Behavioral: Exercise-NMES

Study type: Interventional

Funder types: Other

Identifiers

NCT04153669

R-0019/18

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Control

No Intervention group

Description:

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

Exercise-No NMES

Experimental group

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.

Treatment:

Behavioral: Exercise-No NMES

Exercise-NMES

Experimental group

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.

Treatment:

Behavioral: Exercise-NMES