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

NCT04153669 | Completed

• 1 other identifier: R-0019/18
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis in Children

Keywords

Cystic Fibrosis; Electrostimulation; Combined Training; Physical Fitness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Cardiorespiratory Fitness

  Two assessment points throughout the study:baseline and 8 weeks after the intervention

• Changes in Pulmonary Function

  Two assessment points throughout the study:baseline and 8 weeks after the intervention

• Changes in physical activity levels

  Two assessment points throughout the study:baseline and 8 weeks after the intervention

• Change in quality of life

  Two assessment points throughout the study:baseline and 8 weeks after the intervention

• Food consumption frequency

  One assessment point at baseline:baseline and 8 weeks after the intervention

Study Arms (3)

Control

NO INTERVENTION

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

Exercise-No NMES

EXPERIMENTAL

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

Exercise-NMES

EXPERIMENTAL

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

Interventions

Exercise-NMES BEHAVIORAL

Exercise-NMES

Exercise-NMES

Exercise-No NMES BEHAVIORAL

Exercise-No NMES

Exercise-No NMES

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of CF
• Age: 6-18 years old
• Signature of informed consent of legal guardian and patient.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Escuela de Doctorado e Investigacion, Universidad Europea

Villaviciosa de Odón, 28670, Spain

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Margarita Perez Ruiz, MD

  Universidad Europea de Madrid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor in Exercise Physiology, MD, PhD

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 6, 2019
• Study Start: January 15, 2019
• Primary Completion: March 9, 2020
• Study Completion: March 9, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-07

Locations

ES (1)