Cystic FibrosisNCT03653949
Effects of Aerobic Interval Training on Glucose Tolerance in Children and Adolescents With Cystic Fibrosis
A study testing Educational intervention and Aerobic exercise in people with Cystic Fibrosis, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Educational intervention and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 4 Feb 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Karolinne Souza Monteiro
Natal, Rio Grande do Norte, 59064-741
Karolinne S Monteiro, Master, 5583996387722, karolsm@outlook.com.br
About this study
Official title: Effects of Aerobic Interval Training on Glucose Tolerance in Children and Adolescents With Cystic Fibrosis: Randomized Controlled Trial
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.
Read the detailed description
This is a controlled, randomized, and single blind trial. The first researcher (P1) will be responsible for the randomization process; the second researcher (P2) will be responsible for the evaluations and reevaluations. This evaluator (P2) will be "blind", meaning that for him it is totally unknown in which group each patient will be insert; and the third researcher (P3), will be responsible for statistical analysis.
Individuals will be recruited at the Child and Adolescent Health Care Unit of the Onofre Lopes University Hospital (HUOL) and in the Department of Physical Therapy of the State University of Paraíba (UEPB), Campina Grande - PB, Brazil. They will be evaluated at the Physical Therapy Department of the Federal University of Rio Grande do Norte (UFRN), Natal - RN, Brazil and in the Department of Physical Therapy of the State University of Paraíba (UEPB), in the city of Campina Grande - PB. A pilot study will be carried out and the sample calculation will be done with the data collected to reach a statistical power of 80% and a level of significance of 0.05%. Allocation in the groups will be performed by P1, randomly in blocks by the volunteer being prepubertal or pubertal. The R Core Team software (2015) will be used for this process.
In this study two groups will be considered: control group (CG) and aerobic exercise group (AEG). The CG will be submitted to educational intervention. The AEG will be submitted to the same educational intervention and to the High Intensity Interval Training.
After the pilot study, the patients will be evaluated to obtain information on severity and exacerbation of the disease, quality of life, metabolic evaluation, anthropometric measures, and lung function. All evaluations will be carried out at the same day period (morning). Researcher two (P2) will be responsible for the evaluation and reassessment procedure of the individuals, hence he will be "blind" meaning that for him it is totally unknown in which group each patient will be or was inserted. Individuals will be instructed to do not perform physical activity in the day before the evaluations. After this step, individuals will be randomly distributed in CG or EAG.
Volunteers from both groups will be instructed to maintain nutritional, drug and secretion care. In addition, they will be instructed to do not get engaged in any other kind of physical activity. The intervention will last 2 months and will occur 3 times a week until a total of 24 sessions. After the intervention ends and after the 8-week follow-up, all volunteers will be reevaluated.
- Conditions
- Cystic Fibrosis
- Being tested
- Educational intervention, Aerobic exercise
- Keywords
- Cystic fibrosis, Insulin Resistance, Aerobic Exercise, Child, Adolescents
- Medical subject headings
- Cystic Fibrosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity Interval Training | Experimental | The subjects will participate of an educational intervention and a High Intensity Interval Training. Receives: Other: Educational intervention; Other: Aerobic exercise |
| Control Group | Active comparator | The subjects will participate of an educational intervention. Receives: Other: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose tolerance
Glucose tolerance will be determined by measuring fasting Insulin, fasting glucose, OGTT for all patients.
Measured: Measured at baseline, after 8 and 16 weeks.
Secondary outcomes (5)
Cystic fibrosis Quality of life
the Quality of Life Questionnaire in Cystic Fibrosis (QFC) was translated and validated into Portuguese in 2006. There are four versions of the questionnaire, according to age group: 6 to 11 years (35 questions), 12 and 13 years (35 questions), 14 years or more (50 questions) and parents of children between 6 and 11 years old (44 questions). For children between 6 and 11 years old the application of the questionnaire will be assisted by special cards that will designate the child's response. The questionnaire addresses the physical, body image, digestive, respiratory, emotional, social, nutrition, treatment, vitality, health, social role and weight domains. The scores of each domain range from zero to 100, considering a good quality of life if score above 50.
Measured: Measured at baseline, after 8 and 16 weeks.
Lung Function
Forced expired volume in one second (FEV1) and forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow at 25-75% of the pulmonary volume (FEF25-75).
Measured: Measured at baseline, after 8 and 16 weeks.
Functional capacity
The 3 minute step test
Measured: Measured at baseline, after 8 and 16 weeks.
Respiratory muscle strength
Maximum respiratory pressure
Measured: Measured at baseline, after 8 and 16 weeks.
Exacerbations
Exacerbations of Cystic Fibrosis through the criteria of Fuchs
Measured: Measured at baseline, after 8 and 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start4 Feb 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Estadual da Paraiba
- Responsible party
- Principal investigator, Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte
- Investigators
- Karolinne Monteiro, Master, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653949
- Sponsor's protocol ID
- 88024518.9.1001.5537
- Status last verified
- Oct 2019
- First submitted
- 14 Aug 2018
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31878961
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Interval Training on Glucose Tolerance in Children and Adolescents With Cystic Fibrosis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03653949
- Acronym / sponsor ID
- 88024518.9.1001.5537
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Insulin Resistance, Aerobic Exercise, Child, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- Universidade Estadual da Paraiba
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a controlled, randomized, and single blind trial. The first researcher (P1) will be responsible for the randomization process; the second researcher (P2) will be responsible for the evaluations and reevaluations. This evaluator (P2) will be "blind", meaning that for him it is totally unknown in which group each patient will be insert; and the third researcher (P3), will be responsible for statistical analysis.
Individuals will be recruited at the Child and Adolescent Health Care Unit of the Onofre Lopes University Hospital (HUOL) and in the Department of Physical Therapy of the State University of Paraíba (UEPB), Campina Grande - PB, Brazil. They will be evaluated at the Physical Therapy Department of the Federal University of Rio Grande do Norte (UFRN), Natal - RN, Brazil and in the Department of Physical Therapy of the State University of Paraíba (UEPB), in the city of Campina Grande - PB. A pilot study will be carried out and the sample calculation will be done with the data collected to reach a statistical power of 80% and a level of significance of 0.05%. Allocation in the groups will be performed by P1, randomly in blocks by the volunteer being prepubertal or pubertal. The R Core Team software (2015) will be used for this process.
In this study two groups will be considered: control group (CG) and aerobic exercise group (AEG). The CG will be submitted to educational intervention. The AEG will be submitted to the same educational intervention and to the High Intensity Interval Training.
After the pilot study, the patients will be evaluated to obtain information on severity and exacerbation of the disease, quality of life, metabolic evaluation, anthropometric measures, and lung function. All evaluations will be carried out at the same day period (morning). Researcher two (P2) will be responsible for the evaluation and reassessment procedure of the individuals, hence he will be "blind" meaning that for him it is totally unknown in which group each patient will be or was inserted. Individuals will be instructed to do not perform physical activity in the day before the evaluations. After this step, individuals will be randomly distributed in CG or EAG.
Volunteers from both groups will be instructed to maintain nutritional, drug and secretion care. In addition, they will be instructed to do not get engaged in any other kind of physical activity. The intervention will last 2 months and will occur 3 times a week until a total of 24 sessions. After the intervention ends and after the 8-week follow-up, all volunteers will be reevaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Intensity Interval Training | Experimental | Other: Educational intervention, Other: Aerobic exerciseThe subjects will participate of an educational intervention and a High Intensity Interval Training. |
| Control Group | Active comparator | Other: Educational interventionThe subjects will participate of an educational intervention. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionIt 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. | Other | Control Group, High Intensity Interval Training |
| Aerobic exerciseThe 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. | Other | High Intensity Interval Training |
Primary outcome
Change in glucose tolerance
Time frame: Measured at baseline, after 8 and 16 weeks.
Glucose tolerance will be determined by measuring fasting Insulin, fasting glucose, OGTT for all patients.
5 secondary outcomes
Cystic fibrosis Quality of life
Time frame: Measured at baseline, after 8 and 16 weeks.
Lung Function
Time frame: Measured at baseline, after 8 and 16 weeks.
Functional capacity
Time frame: Measured at baseline, after 8 and 16 weeks.
Respiratory muscle strength
Time frame: Measured at baseline, after 8 and 16 weeks.
Exacerbations
Time frame: Measured at baseline, after 8 and 16 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Derived from this study: PubMed 31878961Monteiro 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karolinne Monteiro, Master principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention and Aerobic exercise in people with Cystic Fibrosis, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karolinne Monteiro, Master (+5584996387722, karolsm@outlook.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glucose tolerance (time frame: Measured at baseline, after 8 and 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03653949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.