NCT03653949

Brief Summary

The purpose of this study is to investigate the effects of aerobic exercise on glucose tolerance in individuals with cystic fibrosis. The hypothesis is that performing High Intensity Interval Training glucose tolerance will improve in individuals with cystic fibrosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

August 14, 2018

Last Update Submit

October 1, 2019

Conditions

Cystic Fibrosis

Keywords

Cystic fibrosisInsulin ResistanceAerobic ExerciseChildAdolescents

Outcome Measures

Primary Outcomes (1)

  • Change in glucose tolerance

    Glucose tolerance will be determined by measuring fasting Insulin, fasting glucose, OGTT for all patients.

    Measured at baseline, after 8 and 16 weeks.

Secondary Outcomes (5)

  • Cystic fibrosis Quality of life

    Measured at baseline, after 8 and 16 weeks.

  • Lung Function

    Measured at baseline, after 8 and 16 weeks.

  • Functional capacity

    Measured at baseline, after 8 and 16 weeks.

  • Respiratory muscle strength

    Measured at baseline, after 8 and 16 weeks.

  • Exacerbations

    Measured at baseline, after 8 and 16 weeks.

Study Arms (2)

High Intensity Interval Training

EXPERIMENTAL

The subjects will participate of an educational intervention and a High Intensity Interval Training.

Other: Educational interventionOther: Aerobic exercise

Control Group

ACTIVE COMPARATOR

The subjects will participate of an educational intervention.

Other: Educational intervention

Interventions

Educational interventionOTHER

It will be an interactive lecture, 60 minutes long. The class will cover physiopathology, complications, treatment and prevention of exacerbations. Audiovisual resources and practical demonstrations of usual care will be used. Individual questions will be answered during the class.

Control GroupHigh Intensity Interval Training
Aerobic exerciseOTHER

The aerobic exercise program will be performed at home, on a cycle ergometer for lower limbs between 24 and 35 minutes: 5 minutes of warm-up, 14 to 25 minutes of high-intensity interval exercise and 5 minutes of cool down.

High Intensity Interval Training

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of cystic fibrosis, according to the Brazilian Guidelines for diagnosis and treatment of CF;
  • Prepubertal or pubertal, according to the Tanner scale
  • Both sex.

You may not qualify if:

  • Inability to perform the protocol established to the study;
  • To be unable to understand and / or perform procedures.
  • Exacerbation of the clinical picture, defined as modification and / or addition of antibiotic.
  • To be pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinne Souza Monteiro

Natal, Rio Grande do Norte, 59064-741, Brazil

RECRUITING

Related Publications (1)

  • Monteiro KS, Azevedo MP, Jales LM, da Silva FEP, Arrais RF, de Mendonca KMPP. Effects of aerobic interval training on glucose tolerance in children and adolescents with cystic fibrosis: a randomized trial protocol. Trials. 2019 Dec 26;20(1):768. doi: 10.1186/s13063-019-3803-8.

    PMID: 31878961DERIVED

MeSH Terms

Conditions

Cystic FibrosisInsulin Resistance

Interventions

Early Intervention, EducationalExercise

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Karolinne Monteiro, Master

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolinne Monteiro, Master

CONTACT

+5584996387722karolsm@outlook.com.br

Thayla Santino, Master

CONTACT

+5583999424386thaylaamorim@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Simple blind (investigador/outcomes aseessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Federal University of Rio Grande do Norte

Study Record Dates

First Submitted

August 14, 2018

First Posted

August 31, 2018

Study Start

February 4, 2019

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

October 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)