AzTrials
AzTrials

Adult Congenital Heart DiseasePhiTNCT07546227

HIIT Versus Moderate Continuous Training in ACHD

A study testing Exercise Intervention in people with Adult Congenital Heart Disease, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single center randomized controlled trial evaluating the effect of an exercise training intervention (interval training or moderate continuous training) compared to usual care (no training) on exercise capacity in patients with congenital heart disease (CHD). Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Adult Congenital Heart Disease
What is being tested?
Exercise Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteCanada
Study dates
20 Oct 2015to 30 Apr 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 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Medically stable patients aged 16 or great with congenital heart disease.

Who cannot join

  • Uncorrected cyanotic congential heart disease (SpO2 </= 85%)
  • Severe outflow tract obstruction (peak Doppler gradient >50 mmHg)
  • Sustained arrhythmia

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Jim Pattison Center for Cardiac Rehabilitation

    Edmonton, Alberta, T6G 2B7

Other trials in Canada

About this study

Official title: Physical Activity in Tetralogy: A Randomized Trial of Interval Training Versus Moderate Continuous Training

This study is a single center randomized controlled trial evaluating the effect of an exercise training intervention (interval training or moderate continuous training) compared to usual care (no training) on exercise capacity in patients with congenital heart disease (CHD).

Our primary aim is to determine the impact of interval training (IT) compared to moderate continuous exercise training (MCT) versus controls (no exercise) on exercise capacity as measured by peak VO2. Secondary aims are to: 1) assess the safety of exercise training in CHD, 2) evaluate the effect of exercise training on cardiac structure and function and 3) assess the effects of exercise training on quality of life and long-term physical activity.

Read the detailed description

Adults with congenital heart disease (ACHD) have reduced exercise capacity which is an independent predictor of adverse outcome including hospitalization and mortality in this patient population. When aerobic exercise capacity is measured by cardiopulmonary exercise testing (CPET), peak oxygen consumption (peak VO2) averages 22ml/kg/min in ACHD, less than half of age matched controls, and similar to patients with heart failure. Factors contributing to low exercise capacity include central factors related to abnormal cardiac anatomy, ventricular systolic and diastolic dysfunction, valvular abnormalities, pulmonary hypertension, chronotropic incompetence and impaired pulmonary function as well as peripheral factors such as skeletal muscle conditioning. Clinicians may further contribute to reluctance around exercise by failing to encourage physical activity or giving inappropriate exercise restrictions to ACHD.

The aim of our study was to explore the efficacy of HIIT compared to MCT on aerobic exercise capacity as measured by peak VO2 in ACHD patients. Secondary aims were to determine the effect of exercise on various physiologic variables, to assess the safety of HIIT in ACHD, to evaluate the effect of exercise training on cardiac structure and function as assessed by cardiac MRI and to measure the impact of exercise training on quality of life (QoL).

This was a single center randomized controlled trial designed in accordance with CONSORT guidelines. Participants were randomized with a 1:1:1 ratio into three groups: HIIT, MCT or control group. Randomization occurred by clusters defined by week of attendance in the clinic. Permuted blocks of 3, 6, and 9 were used to ensure a similar number of weeks randomized to the three groups, with randomization sequence generated by one author (AM). Participants were enrolled by a study coordinator who assigned participants to one of the three groups. Participants underwent testing at baseline and after 12 weeks of the intervention.

Being tested
Exercise Intervention
Keywords
Exercise, Cardiopulmonary testing, Cardiac MRI, Randomized clinical trial, Cardiac rehabilitation
Medical subject headings
Heart Defects, Congenital, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise InterventionOther

    Participants will take part in 3 exercise sessions per week of either HIIT or MCT training.

Study groups in NCT07546227
Study groupRoleWhat they receive
HIITExperimentalHigh intensity interval training: 3 session per week of long-interval protocol involving 5 minutes of warmup, 5 intervals of 4 minutes of internse aerobic activity with 4 periods of 3 minutes of low to moderate intensity activity and a 5 minute cool down period.
Receives: Other: Exercise Intervention
MCTExperimentalModerate continuous training: 3 sessions per week involving a 5 minut warmup, 40 minutes of aerobic activity and 5 minutes of cool down.
Receives: Other: Exercise Intervention
ControlNo interventionControl group participants will continue their usual level of physical activity.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in peak VO2 from baseline to 12 weeks post enrollment

    Participants will complete a cardiopulmonary exercise test at baseline and after 12 weeks to determine peak VO2 values.

    Measured: From enrollment to the end of the 12 week treatment

Secondary outcomes (4)

  1. Determination of adverse events

    High intensity exercise has the potential to transiently increase the risk of arrhythmias and myocardial infarction in susceptible persons. Participants will be monitored throughout exercise for any adverse events defined as cardiac arrest, myocardial infarction, sustained ventricular or suprraventricular arrhythmias or heart failure.

    Measured: Participants will be monitored throughout the exercise training and one hour afterward.

  2. Cardiac adaptation

    Cardiac MRI will be used to assess right ventricular volumes and ejection fraction. Pulmonary regurgitation fraction, left ventricular volumes and ejection fraction will also be assess.

    Measured: Cardiac MRI's will be performed at baseline with follow-up scans at 4 weeks of starting and at completion of the 12 week intervention.

  3. The effect of exercise training on quality of life.

    Participants will complete a quality of life questionnaire, satisfaction with life scale and New York Heart Association (NYHA) Functional Classification.

    Measured: Participants will complete questionnaires during study visits or be sent a link by email to complete the questionnaires on-line at baseline, 3 months (after exercise training intervention) and 6 months after randomization.

  4. Impact of exercise program on physical activity levels.

    Participants will wear SenseWear arm bands (accelerometers) to describe baseline physical activity levels and to assess long-term changes in physical activity 6 months after randomization. Data will be acquired for 4 days at each time-point and change from baseline compared between exercise training groups and usual care.

    Measured: Participants will wear the accelerometers at baseline and 6 months after randomization to collect data for 4 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2026
  2. Study start20 Oct 2015
  3. Primary completion31 May 2023
  4. Study completion30 Apr 2024

Resources

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
This study is a 3-arm single center randomized controlled trial. Participants will be randomized to HIIT, MCT or control group
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07546227
Sponsor's protocol ID
Pro00059680
Acronym
PhiT
Status last verified
Apr 2026
First submitted
15 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. Data will be analyzed and presented per treatment group.

Publications

  • Swan L, Hillis WS. Exercise prescription in adults with congenital heart disease: a long way to go. Heart. 2000 Jun;83(6):685-7. doi: 10.1136/heart.83.6.685.

    PubMed 10814630

  • Budts W, Borjesson M, Chessa M, van Buuren F, Trigo Trindade P, Corrado D, Heidbuchel H, Webb G, Holm J, Papadakis M. Physical activity in adolescents and adults with congenital heart defects: individualized exercise prescription. Eur Heart J. 2013 Dec;34(47):3669-74. doi: 10.1093/eurheartj/eht433. Epub 2013 Nov 7. No abstract available.

    PubMed 24204010

  • Holloway TM, Chesssex C, Grace SL, Oechslin E, Spriet LL, Kovacs AH. A call for adult congenital heart disease patient participation in cardiac rehabilitation. Int J Cardiol. 2011 Aug 4;150(3):345-6. doi: 10.1016/j.ijcard.2011.05.031. Epub 2011 Jun 8. No abstract available.

    PubMed 21641052

  • Diller GP, Dimopoulos K, Okonko D, Li W, Babu-Narayan SV, Broberg CS, Johansson B, Bouzas B, Mullen MJ, Poole-Wilson PA, Francis DP, Gatzoulis MA. Exercise intolerance in adult congenital heart disease: comparative severity, correlates, and prognostic implication. Circulation. 2005 Aug 9;112(6):828-35. doi: 10.1161/CIRCULATIONAHA.104.529800. Epub 2005 Aug 1.

    PubMed 16061735

  • Marelli AJ, Mackie AS, Ionescu-Ittu R, Rahme E, Pilote L. Congenital heart disease in the general population: changing prevalence and age distribution. Circulation. 2007 Jan 16;115(2):163-72. doi: 10.1161/CIRCULATIONAHA.106.627224. Epub 2007 Jan 8.

    PubMed 17210844

  • Mao RT, Willner JP, Pylypchuk S, Mathew A, Windram J, Mackie AS, Haennel R, Vonder Muhll IF. High-Intensity Interval Training vs Moderate Continuous Training in Adults With Congenital Heart Disease: A Randomized Controlled Trial. Can J Cardiol. 2026 Jun 26:S0828-282X(26)00642-2. doi: 10.1016/j.cjca.2026.06.020. Online ahead of print.

    PubMed 42362048

Questions about this trial

What is this clinical trial studying?

A study testing Exercise Intervention in people with Adult Congenital Heart Disease, run by University of Alberta 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 1 inclusion and 3 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 29 Apr 2026. 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?

Change in peak VO2 from baseline to 12 weeks post enrollment (time frame: From enrollment to the end of the 12 week treatment). 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 NCT07546227, which also lists 6 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 29 Apr 2026.

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