Prematurity; ExtremeNCT03504215
Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health.
A study testing Exercise Intervention in people with Prematurity; Extreme, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later chronic disease and mortality. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Prematurity; Extreme
- What is being tested?
- Exercise Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 2 Mar 2018to 27 Jan 2021
- 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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both groups :
- Aged between 18-29 years old
- Less than 120 minutes of exercise per week
- Willingness to be part of the 14 weeks exercise intervention
- Preterm group:
- Born under 29 weeks of gestation
Show all 9Show fewer
- Term group :
- Born between 37-41 weeks
- Appropriate weight fo gestational weight
Who cannot join
- Pregnancy
- conditions excludins individual from exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health
In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later chronic disease and mortality. The reason why individuals born preterm have exercise limitation remains unclear and may be a consequence of impact of preterm birth and associated neonatal difficulties on the development of organs important for exercise, namely the lungs, the heart, the vessels (which bring blood and oxygen to the muscles) and the muscles. It is well known that exercise benefits overall health in at-risk as well diseased populations. However, whether exercise training can improve fitness in young adults born preterm was not demonstrated and whether the cardiovascular, pulmonary and muscle impairments associated with preterm birth are reversible through exercise intervention in young adulthood is unknown.
Read the detailed description
The investigators postulate that a 14-week exercise intervention will improve exercise capacity in preterm adults, as seen in other at-risk populations, in correlation with measures of vascular health, heart and muscle perfusion and oxygenation, and pulmonary function detected by cutting edge and highly sensitive imaging and circulating biomarkers. These markers are more sensitive to pre-disease changes than traditional health measures, and are largely unexplored in preterm populations.
The investigators will:
- Determine whether a 14-week supervised exercise training improves exercise capacity in young adults (18-29 years old) born very preterm at <29 weeks gestational age.
- Examine whether improvement in exercise capacity is associated with changes in (a) markers of vascular health including circulating endothelial progenitor cells and microparticles, (b) cardiac perfusion by cutting-edge oxygenation-sensitive cardiovascular magnetic resonance imaging (MRI), (c) lung regional ventilation measured by newly developed hydrogen proton (1H) MRI, (d) muscle oxygenation during exercise.
- Compare the response of the above measures to exercise intervention between young adults born very preterm and term controls.
- Conditions
- Prematurity; Extreme
- Being tested
- Exercise Intervention
- Keywords
- extremely preterm, young adults, term, exercise capacity, pulmonary function, muscle oxygenation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned intervention : 14-week supervised intervention of aerobic and resistance training.
| Study group | Role | What they receive |
|---|---|---|
| young adults | Experimental | Both young adults born preterm (n=60) and term (n=30) will undergo the exercise intervention. Receives: Other: Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the peak oxygen consumption before and after the physical intervention
Respiratory exchange ratio (RER) (%)
Measured: 16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention
Oxygen uptake (VO2max) (mL/min)
Measured: 16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention
Carbon dioxide production (VCO2) (L/min)
Measured: 16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention
VO2peak (mL/kg/min)
Measured: 16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention
Weight (kg)
Measured: 16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention
Height (cm)
Measured: 16 weeks
Measurement of the peak oxygen consumption before and after the physical intervention
Age (years)
Measured: 16 weeks
Secondary outcomes (6)
Cardiac oxygen sensitive MRI (OS-MRI)
myocardial perfusion in response to CO2 modulation
Measured: 18 weeks
Lung regional ventilation using a 3D proton MRI ultrashort ecotime
Parenchyma signal intensity (SI)
Measured: 1 week
Muscle oxygenation
Near-infrared spectroscopy (NIRS)
Measured: 18 weeks
Pulmonary function
Forced spirometry (FEV1, L)
Measured: 18 weeks
Pulmonary function
Forced spirometry (FVC, L)
Measured: 18 weeks
Pulmonary function
Forced spirometry (FEF25-75, L/s)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start2 Mar 2018
- Primary completion18 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prematurity; ExtremeStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Group assignments. Both groups are evaluated before and after a 14 week supervised exercise (aerobic and resistance training) intervention.
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Western University, Canada, Université de Montréal, Ottawa Hospital Research Institute, University of Alberta
- Responsible party
- Principal investigator, Anne Monique NUYT,MD, St. Justine's Hospital
- Investigators
- Anne Monique Nuyt, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504215
- Sponsor's protocol ID
- HAPI Fit Clinical Study
- Status last verified
- Nov 2022
- First submitted
- 10 Apr 2018
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Girard-Bock C, Michaud C, Dartora DR, Al-Simaani A, Bastien-Tardif C, Deprez A, Flahault A, Bigras JL, Lapointe A, Du Pont-Thibodeau A, Villeneuve A, Sonea A, Chanane N, Cloutier A, He Y, Mathieu ME, Luu TM, Nuyt AM. Clinical study: Cardiovascular outcomes after a 14-week exercise intervention in young adults born preterm. Pediatr Res. 2026 Jun 3. doi: 10.1038/s41390-026-05130-0. Online ahead of print.
PubMed 42236922Tardif CB, Mathieu ME, Caru M, Al-Simaani A, Girard-Bock C, Cloutier A, Stickland MK, Nuyt AM, Luu TM. HAPI Fit: An Exercise Intervention to Improve Peak Aerobic Capacity in Young Adults Born Very Preterm. Med Sci Sports Exerc. 2024 Jan 1;56(1):44-52. doi: 10.1249/MSS.0000000000003279. Epub 2023 Aug 30.
PubMed 37707478
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention to Rescue the Adverse Effect of Preterm Birth on Cardiovascular and Pulmonary Health
- ClinicalTrials.gov ID
- NCT03504215
- Acronym / sponsor ID
- HAPI Fit Clinical Study
- Conditions
- Prematurity; Extreme
- Keywords
- extremely preterm, young adults, term, exercise capacity, pulmonary function, muscle oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Western University, Canada, Université de Montréal, Ottawa Hospital Research Institute, University of Alberta
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 20 Apr 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.
In spite of advances in neonatal intensive care allowing the first generation survivors of extreme prematurity to now reach young adulthood, these individuals present with reduced exercise capacity; a strong predictor of later chronic disease and mortality. The reason why individuals born preterm have exercise limitation remains unclear and may be a consequence of impact of preterm birth and associated neonatal difficulties on the development of organs important for exercise, namely the lungs, the heart, the vessels (which bring blood and oxygen to the muscles) and the muscles. It is well known that exercise benefits overall health in at-risk as well diseased populations. However, whether exercise training can improve fitness in young adults born preterm was not demonstrated and whether the cardiovascular, pulmonary and muscle impairments associated with preterm birth are reversible through exercise intervention in young adulthood is unknown.
Detailed description
The investigators postulate that a 14-week exercise intervention will improve exercise capacity in preterm adults, as seen in other at-risk populations, in correlation with measures of vascular health, heart and muscle perfusion and oxygenation, and pulmonary function detected by cutting edge and highly sensitive imaging and circulating biomarkers. These markers are more sensitive to pre-disease changes than traditional health measures, and are largely unexplored in preterm populations.
The investigators will:
- Determine whether a 14-week supervised exercise training improves exercise capacity in young adults (18-29 years old) born very preterm at <29 weeks gestational age.
- Examine whether improvement in exercise capacity is associated with changes in (a) markers of vascular health including circulating endothelial progenitor cells and microparticles, (b) cardiac perfusion by cutting-edge oxygenation-sensitive cardiovascular magnetic resonance imaging (MRI), (c) lung regional ventilation measured by newly developed hydrogen proton (1H) MRI, (d) muscle oxygenation during exercise.
- Compare the response of the above measures to exercise intervention between young adults born very preterm and term controls.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Group assignments. Both groups are evaluated before and after a 14 week supervised exercise (aerobic and resistance training) intervention.
| Arm | Type | Receives |
|---|---|---|
| young adults | Experimental | Other: Exercise InterventionBoth young adults born preterm (n=60) and term (n=30) will undergo the exercise intervention. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Aged between 18-29 years old
- Less than 120 minutes of exercise per week
- Willingness to be part of the 14 weeks exercise intervention
- Born under 29 weeks of gestation
- Born between 37-41 weeks
Key exclusion criteria (2 listed)
- Pregnancy
- conditions excludins individual from exercise
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 InterventionAssigned intervention : 14-week supervised intervention of aerobic and resistance training. | Other | young adults |
Primary outcome
Measurement of the peak oxygen consumption before and after the physical intervention
Time frame: 16 weeks
Respiratory exchange ratio (RER) (%)
Measurement of the peak oxygen consumption before and after the physical intervention
Time frame: 16 weeks
Oxygen uptake (VO2max) (mL/min)
Measurement of the peak oxygen consumption before and after the physical intervention
Time frame: 16 weeks
Carbon dioxide production (VCO2) (L/min)
Measurement of the peak oxygen consumption before and after the physical intervention
Time frame: 16 weeks
VO2peak (mL/kg/min)
Measurement of the peak oxygen consumption before and after the physical intervention
Time frame: 16 weeks
Weight (kg)
Measurement of the peak oxygen consumption before and after the physical intervention
Time frame: 16 weeks
Height (cm)
Measurement of the peak oxygen consumption before and after the physical intervention
Time frame: 16 weeks
Age (years)
6 secondary outcomes
Cardiac oxygen sensitive MRI (OS-MRI)
Time frame: 18 weeks
Lung regional ventilation using a 3D proton MRI ultrashort ecotime
Time frame: 1 week
Muscle oxygenation
Time frame: 18 weeks
Pulmonary function
Time frame: 18 weeks
Pulmonary function
Time frame: 18 weeks
Pulmonary function
Time frame: 18 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 3 Nov 2022.
- Derived from this study: PubMed 42236922Girard-Bock C, Michaud C, Dartora DR, Al-Simaani A, Bastien-Tardif C, Deprez A, Flahault A, Bigras JL, Lapointe A, Du Pont-Thibodeau A, Villeneuve A, Sonea A, Chanane N, Cloutier A, He Y, Mathieu ME, Luu TM, Nuyt AM. Clinical study: Cardiovascular outcomes after a 14-week exercise intervention in young adults born preterm. Pediatr Res. 2026 Jun 3. doi: 10.1038/s41390-026-05130-0. Online ahead of print.
- Derived from this study: PubMed 37707478Tardif CB, Mathieu ME, Caru M, Al-Simaani A, Girard-Bock C, Cloutier A, Stickland MK, Nuyt AM, Luu TM. HAPI Fit: An Exercise Intervention to Improve Peak Aerobic Capacity in Young Adults Born Very Preterm. Med Sci Sports Exerc. 2024 Jan 1;56(1):44-52. doi: 10.1249/MSS.0000000000003279. Epub 2023 Aug 30.
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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.
Anne Monique Nuyt, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention in people with Prematurity; Extreme, run by St. Justine's Hospital at 1 site in Canada.
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 9 inclusion and 2 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 3 Nov 2022. 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 Canada. 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?
Measurement of the peak oxygen consumption before and after the physical intervention (time frame: 16 weeks). The study lists 7 primary outcomes in all. 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 NCT03504215, which also lists 2 linked publications.
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 3 Nov 2022.