Bronchiolitis ObliteransPIBOHIITNCT05881538
High Intensity Intervallic Training in Children With Bronchiolitis Obliterans
A study testing Exercise group in people with Bronchiolitis Obliterans, run by Universitat Internacional de Catalunya at 3 sites in Spain.
Trial summary
Post-Infectious Bronchiolitis Obliterans (PIBO) is an irreversible obstructive lung disease characterized by subepithelial inflammation and fibrotic narrowing of the bronchioles after lower respiratory tract infection. This disease is diagnosed mainly in children, more frequently before the age of 2 years. Read more about this study
- Who is it for?
- Ages 6 to 20 years
- Conditions the study is for
- Bronchiolitis Obliterans
- What is being tested?
- Exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesSpain
- Study dates
- 29 May 2023to 29 Jul 2024
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Postinfectious bronchiolitis obliterans;
- Clinical stability at the time of the assessments;
- Age between 6 and 20 years old.
Who cannot join
- Symptoms of pulmonary exacerbation during the last four weeks;
- Diagnosis of other cardiorespiratory diseases leading to symptoms of persistent respiratory dysfunction;
- Difficulty in comprehension or musculoskeletal alterations that may influence the assessments;
- Pregnancy;
- Transplant list inclusion.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Hospital Universitari Vall d'Hebron
Barcelona, Catalonia, 08035
Hospital Universitario Donostia
Donostia / San Sebastian, Basque Country, 20014
Hospital Universitario Infantil Niño Jesús
Madrid, 28009
About this study
Official title: Effectiveness of a High-intensity Intervallic Training Program in Children and Adolescents With Post-infectious Bronchiolitis Obliterans: a Randomized Controlled Trial
Post-Infectious Bronchiolitis Obliterans (PIBO) is an irreversible obstructive lung disease characterized by subepithelial inflammation and fibrotic narrowing of the bronchioles after lower respiratory tract infection. This disease is diagnosed mainly in children, more frequently before the age of 2 years. Due to symptoms such as dry cough and dyspnea sensation, most of these patients have low levels of physical activity compared to healthy individuals. Physical activity can positively influence oxygen consumption, muscle strength, and quality of life. High levels of oxygen consumption are associated with a lower risk of respiratory disease and hospitalization. High-intensity interval training (HIIT) may be an effective way to improve oxygen consumption, muscle strength, and quality of life in patients with chronic diseases. HIIT has been shown to produce less dyspnea sensation and to be more entertaining in children and adolescents with respiratory disease compared to continuous training. Thus, the investigators propose to perform telematically real-time guided training to reduce travel times and additional costs to patients.
Objective: To analyze the effects of a telematically supervised high-intensity intervallic training program on aerobic fitness, as well as functional/clinical outcomes in patients with PIBO.
Methods: Randomized controlled trial with two groups. Exercise group: 16-week HIIT training conducted telematically; Control group: will follow the routine physician's recommendations. Patients will be recruited at Vall D'Hebrón University Hospital (Barcelona), Niño Jesús University Hospital (Madrid), and Donostia Universitary Hospital (San Sebastián). Criteria for participation: (I) Diagnosis of PIBO; (II) Clinically stable at the time of the assessments; (III) Age between 6 to 20 years old.
- Conditions
- Bronchiolitis Obliterans
- Being tested
- Exercise group
- Keywords
- High intensity interval training, Post-infectious bronchiolitis obliterans, Telematic program, Cardiorespiratory fitness
- Medical subject headings
- Bronchiolitis Obliterans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupOther
Also called High Intensity Interval Training
Participants will perform a 16-week High Intensity Interval Training exercise program, twice a week. The intervention will be conducted telematically with real time supervision.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | 16 weeks of a "High Intensity Interval Training" exercise program conducted telematically with real time supervision twice a week.
The exercise program consists of a circuit of exercises aiming to achieve a target heart rate for each fitness level. Receives: Other: Exercise group |
| Control group | No intervention | Routine physician recommendations for physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peak oxygen consumption
Change in peak oxygen consumption (mL/kg/min) will be evaluated through cardiopulmonary exercise testing (CPET).
Measured: Change from baseline to 16 weeks
Change in time to ventilatory threshold
Change in time to ventilatory threshold (minutes) will be evaluated through cardiopulmonary exercise testing (CPET).
Measured: Change from baseline to 16 weeks
Change in percent oxygen consumption at ventilatory threshold
Change in percent oxygen consumption at ventilatory threshold will be evaluated through cardiopulmonary exercise testing (CPET).
Measured: Change from baseline to 16 weeks
Change in ventilatory efficiency
Change in ventilatory efficiency will be evaluated by combining ventilation (VE) and carbon dioxide production (VCO2) measurements to report VE/VCO2 ratio, evaluated through cardiopulmonary exercise testing (CPET).
Measured: Change from baseline to 16 weeks
Secondary outcomes (11)
Change in forced expiratory volume in the first second
Change in forced expiratory volume in the first second (liters) will be evaluated through spirometry.
Measured: Change from baseline to 16 weeks
Change in forced vital capacity
Change in forced vital capacity (liters) will be evaluated through spirometry.
Measured: Change from baseline to 16 weeks
Change in forced expiratory flow between 25 and 75% of forced vital capacity
Change in forced expiratory flow between 25 and 75% of forced vital capacity (liters/minute) will be evaluated through spirometry.
Measured: Change from baseline to 16 weeks
Change in muscle strength
Changes in muscle strength will be evaluated using a dynamometer.
Measured: Change from baseline to 16 weeks
Change in lower body strength
Changes in lower body strength will be evaluated using the 30 seconds Sit to Stand Test (30STS).
Measured: Change from baseline to 16 weeks
Change in free fat mass
Changes in free fat mass (percent) will be evaluated through bioimpedance.
Measured: Change from baseline to 16 weeks
Change in lean mass
Changes in lean mass (percent) will be evaluated through bioimpedance.
Measured: Change from baseline to 16 weeks
Change in hip-waist ratio
Changes in hip-waist ratio will be evaluated by combining hip circumference and waist circumference measurements using a non-stretchable tape measure.
Measured: Change from baseline to 16 weeks
Change in body mass index
Changes in body mass index will be evaluated by combining weight and height measurements to report BMI (kg/m^2).
Measured: Change from baseline to 16 weeks
Change in quality of life
Changes in quality of life will be evaluated through the Saint George's Respiratory Questionnaire (SRQ). The overall result of the scale is a numerical value from 0 to 100, with the highest values corresponding to a worse quality of life.
Measured: Change from baseline to 16 weeks
Change in dyspnea
Changes in dyspnea will be evaluated through the Medical Research Council (mMRC) modified dyspnea scale. The overall result of the scale is a numerical value from 0 to 4, where the highest value corresponds to the worse dyspnea.
Measured: Change from baseline to 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 May 2023
- Study start29 May 2023
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis ObliteransStudies 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
- Model description
- Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Collaborators
- Consejo Superior de Deportes, Spain
- Responsible party
- Principal investigator, Márcio Vinícius Fagundes Donadio, Universitat Internacional de Catalunya
- Investigators
- Márcio VF Donadio, PhD, Principal investigator, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881538
- Sponsor's protocol ID
- PIBOHIIT-UIC
- Acronym
- PIBOHIIT
- Status last verified
- Dec 2024
- First submitted
- 24 Apr 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will collect patients' personal data and clinical history by means of the information delivered by the participating hospital. These data will be stored and coded in an Excel file in order to protect confidentiality before, during and after the study. All information will be entered and stored electronically in the institutional platform REDCAP hosted on the hospitals' server.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a High-intensity Intervallic Training Program in Children and Adolescents With Post-infectious Bronchiolitis Obliterans: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05881538
- Acronym / sponsor ID
- PIBOHIIT / PIBOHIIT-UIC
- Conditions
- Bronchiolitis Obliterans
- Keywords
- High intensity interval training, Post-infectious bronchiolitis obliterans, Telematic program, Cardiorespiratory fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Collaborators
- Consejo Superior de Deportes, Spain
- Study start
- 29 May 2023 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 31 May 2023 (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.
Post-Infectious Bronchiolitis Obliterans (PIBO) is an irreversible obstructive lung disease characterized by subepithelial inflammation and fibrotic narrowing of the bronchioles after lower respiratory tract infection. This disease is diagnosed mainly in children, more frequently before the age of 2 years. Due to symptoms such as dry cough and dyspnea sensation, most of these patients have low levels of physical activity compared to healthy individuals. Physical activity can positively influence oxygen consumption, muscle strength, and quality of life. High levels of oxygen consumption are associated with a lower risk of respiratory disease and hospitalization. High-intensity interval training (HIIT) may be an effective way to improve oxygen consumption, muscle strength, and quality of life in patients with chronic diseases. HIIT has been shown to produce less dyspnea sensation and to be more entertaining in children and adolescents with respiratory disease compared to continuous training. Thus, the investigators propose to perform telematically real-time guided training to reduce travel times and additional costs to patients.
Objective: To analyze the effects of a telematically supervised high-intensity intervallic training program on aerobic fitness, as well as functional/clinical outcomes in patients with PIBO.
Methods: Randomized controlled trial with two groups. Exercise group: 16-week HIIT training conducted telematically; Control group: will follow the routine physician's recommendations. Patients will be recruited at Vall D'Hebrón University Hospital (Barcelona), Niño Jesús University Hospital (Madrid), and Donostia Universitary Hospital (San Sebastián). Criteria for participation: (I) Diagnosis of PIBO; (II) Clinically stable at the time of the assessments; (III) Age between 6 to 20 years old.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicenter study, randomized controlled trial in two parallel groups (ratio 1:1), double blinded.
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Exercise group16 weeks of a "High Intensity Interval Training" exercise program conducted telematically with real time supervision twice a week. The exercise program consists of a circuit of exercises aiming to achieve a target heart rate for each fitness level. |
| Control group | No intervention | –Routine physician recommendations for physical activity. |
Who may qualify
- Ages
- 6 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of Postinfectious bronchiolitis obliterans;
- Clinical stability at the time of the assessments;
- Age between 6 and 20 years old.
Key exclusion criteria (5 listed)
- Symptoms of pulmonary exacerbation during the last four weeks;
- Diagnosis of other cardiorespiratory diseases leading to symptoms of persistent respiratory dysfunction;
- Difficulty in comprehension or musculoskeletal alterations that may influence the assessments;
- Pregnancy;
- Transplant list inclusion.
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 |
|---|---|---|
| Exercise groupAlso: High Intensity Interval TrainingParticipants will perform a 16-week High Intensity Interval Training exercise program, twice a week. The intervention will be conducted telematically with real time supervision. | Other | Exercise group |
Primary outcome
Change in peak oxygen consumption
Time frame: Change from baseline to 16 weeks
Change in peak oxygen consumption (mL/kg/min) will be evaluated through cardiopulmonary exercise testing (CPET).
Change in time to ventilatory threshold
Time frame: Change from baseline to 16 weeks
Change in time to ventilatory threshold (minutes) will be evaluated through cardiopulmonary exercise testing (CPET).
Change in percent oxygen consumption at ventilatory threshold
Time frame: Change from baseline to 16 weeks
Change in percent oxygen consumption at ventilatory threshold will be evaluated through cardiopulmonary exercise testing (CPET).
Change in ventilatory efficiency
Time frame: Change from baseline to 16 weeks
Change in ventilatory efficiency will be evaluated by combining ventilation (VE) and carbon dioxide production (VCO2) measurements to report VE/VCO2 ratio, evaluated through cardiopulmonary exercise testing (CPET).
11 secondary outcomes
Change in forced expiratory volume in the first second
Time frame: Change from baseline to 16 weeks
Change in forced vital capacity
Time frame: Change from baseline to 16 weeks
Change in forced expiratory flow between 25 and 75% of forced vital capacity
Time frame: Change from baseline to 16 weeks
Change in muscle strength
Time frame: Change from baseline to 16 weeks
Change in lower body strength
Time frame: Change from baseline to 16 weeks
Change in free fat mass
Time frame: Change from baseline to 16 weeks
Change in lean mass
Time frame: Change from baseline to 16 weeks
Change in hip-waist ratio
Time frame: Change from baseline to 16 weeks
Change in body mass index
Time frame: Change from baseline to 16 weeks
Change in quality of life
Time frame: Change from baseline to 16 weeks
Change in dyspnea
Time frame: Change from baseline to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Yes. The investigators will collect patients' personal data and clinical history by means of the information delivered by the participating hospital. These data will be stored and coded in an Excel file in order to protect confidentiality before, during and after the study. All information will be entered and stored electronically in the institutional platform REDCAP hosted on the hospitals' server.
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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.
Márcio VF Donadio, PhD principal investigator
Universitat Internacional de Catalunya
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise group in people with Bronchiolitis Obliterans, run by Universitat Internacional de Catalunya at 3 sites in Spain.
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 5 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: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peak oxygen consumption (time frame: Change from baseline to 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2024.