HIIT Versus Moderate Continuous Training in ACHD

NCT07546227 | Completed

• 1 other identifier: Pro00059680
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Adult Congenital Heart Disease

Keywords

Exercise; Cardiopulmonary testing; Cardiac MRI; Randomized clinical trial; Cardiac rehabilitation

Outcome Measures

Primary Outcomes (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.

  From enrollment to the end of the 12 week treatment

Secondary Outcomes (4)

• Determination of adverse events

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

• Cardiac adaptation

  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.

• The effect of exercise training on quality of life.

  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.

• Impact of exercise program on physical activity levels.

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

Study Arms (3)

HIIT

EXPERIMENTAL

High 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.

Other: Exercise Intervention

MCT

EXPERIMENTAL

Moderate continuous training: 3 sessions per week involving a 5 minut warmup, 40 minutes of aerobic activity and 5 minutes of cool down.

Other: Exercise Intervention

Control

NO INTERVENTION

Control group participants will continue their usual level of physical activity.

Interventions

Exercise Intervention OTHER

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

HIIT; MCT

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Jim Pattison Center for Cardiac Rehabilitation

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (5)

• 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.

  PMID: 10814630 BACKGROUND

• 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.

  PMID: 24204010 BACKGROUND

• 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.

  PMID: 21641052 BACKGROUND

• 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.

  PMID: 16061735 BACKGROUND

• 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.

  PMID: 17210844 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a 3-arm single center randomized controlled trial. Participants will be randomized to HIIT, MCT or control group

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 22, 2026
• Study Start: October 20, 2015
• Primary Completion: May 31, 2023
• Study Completion: April 30, 2024
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)