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Completed

NCT Number: NCT04153669

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

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.

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Key information

Conditions

Cystic Fibrosis in Children Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Escuela de Doctorado e Investigacion, Universidad Europea

Villaviciosa de Odón, 28670, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise-NMES

Behavioral

Exercise-NMES

Exercise-No NMES

Behavioral

Exercise-No NMES

Primary outcomes

  1. Change in Strength

    Time frame: 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 outcomes

  1. Change in Cardiorespiratory Fitness

    Time frame: 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)

  2. Changes in Pulmonary Function

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

    Changes in pulmonary function will be measured using Spirometry

  3. Changes in physical activity levels

    Time frame: 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)

  4. Change in quality of life

    Time frame: 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)

  5. Food consumption frequency

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

    The food consumption frequency will be measured using food frequency questionnaire (FFQ)

Sponsors and collaborators

Lead sponsor

Universidad Europea de Madrid

Other

Registry information

Official study title

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

Acronym: ECOMIRIN

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 6, 2019
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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