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

Not Applicable

Completed

• Conditions: Cystic Fibrosis in Children
• Interventions: Behavioral: Exercise-NMES; Behavioral: Exercise-No NMES

• Registration Number: NCT04153669
• Lead Sponsor: Universidad Europea de Madrid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-11-03
• Study First Posted: 2019-11-06
• Primary Completion: 2020-03-09
• Study Completion: 2020-03-09
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-23
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise-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.
Exercise-No NMES	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.

Primary Outcome Measures

Name	Time	Method
Change in Strength	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)

Secondary Outcome Measures

Name	Time	Method
Change in Cardiorespiratory Fitness	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)
Changes in Pulmonary Function	Two assessment points throughout the study:baseline and 8 weeks after the intervention	Changes in pulmonary function will be measured using Spirometry
Change in quality of life	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)
Changes in physical activity levels	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)
Food consumption frequency	One assessment point at baseline:baseline and 8 weeks after the intervention	The food consumption frequency will be measured using food frequency questionnaire (FFQ)

Trial Locations

Locations (1)

Escuela de Doctorado e Investigacion, Universidad Europea; 🇪🇸 Villaviciosa De Odón, Spain