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RecruitingNCT05023785HIMALAYASUpdated Nov 26, 2025

The HIMALAYAS Trial and Lifestyle Changes in Pediatric, Adolescent and Young Adult Cancer Survivors Study: A Multicentre Randomized Controlled Trial

An interventional study of Cardio-oncology Rehabilitation (CORE) in Heart Failure, Cardiotoxicity and Cancer, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-11-26.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
336
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Pediatric, adolescent and young adult cancer survivors (PAYA-CS) are at higher risk of cardiovascular (CV) morbidity and mortality. This is a consequence of prior cancer-related therapies that have the potential of producing cardiac dysfunction, reducing cardiorespiratory fitness (reduced VO2peak) and psychosocial morbidities (i.e., anxiety and depression). A reduction of physical activity levels can evoke functional limitations resulting in a vicious cycle of reduced exercise tolerance and physical deterioration. To date, there is limited evidence on the use of non-pharmacological strategies such as Cardio-Oncology Rehabilitation (CORE) including structured exercise, behavioural support and risk factor management to improve the outcomes of this underserved population. The HIMALAYAS study is a randomized controlled trial designed to evaluate the impact of a CORE intervention (consisting of six-months home and onsite-based structured moderate to high-intensity aerobic exercise training and CVD risk factor management) on CV and psychosocial health, and the cardiovascular disease risk in PAYA-CS with mild heart dysfunction (stage B heart failure) compared to standard of care (i.e. providing guidance on the current exercise recommendations for cancer survivors). The primary objective of the HIMALAYAS study is to determine whether a six-month supervised CORE intervention, consisting of individualized moderate to high-intensity aerobic exercise training, CVD risk factor modification and enhanced online behavioral support, improves cardiorespiratory fitness (VO2peak; primary outcome), cardiac function, CVD risk factors and biomarkers, and patient-reported outcomes (PROs) at six- months follow-up compared to standard of care (CON) in PAYA-CS with stage B heart failure. The secondary objective is to assess the same outcomes at 12- and 24-months follow-up. We will recruit 336 patients across 5 sites in Canada and upto 134 patients at UHN in 3 years and conclude in 6 years.

Read the detailed description

Over 90,000 North Americans are diagnosed with cancer before the age of 40. Improved cancer therapies have led to an exponential growth in the number of pediatric, adolescent, and young adult cancer survivors (AYA-CS) who are expected to live 50-60 years beyond diagnosis. However, AYA-CS are at increased risk of developing multiple cancer- and treatment-related morbidities including poor fitness (e.g., low VO2peak), hypertension (HTN), diabetes, and poor mental health, which all contribute to premature cardiovascular disease (CVD). The prevalence of CVD events (e.g. heart failure, heart attack, stroke) is up to 23.8% in adult survivors of pediatric cancers with long term follow-up after treatment. The incidence of subclinical CVD, which is a precursor to CVD events, is even higher in AYA-CS; up to 40%, 11%, and 5% experience subclinical cardiomyopathy measured by abnormal global longitudinal strain (GLS), diastolic dysfunction (DD) or mild reduction in left ventricular ejection fraction (LVEF), respectively, and 18% experience reduced aerobic fitness. The treatment of modifiable CVD risk factors must be considered a fundamental target for improving CVD health-related outcomes in AYA-CS. To this end, exercise and best-practices for CVD risk factor modification are integral to a cardiac rehabilitation model. Traditional cardiac rehabilitation models for patients with CVD (consisting of exercise, CVD risk factor treatment, and patient education) are safe and effective in improving HRQoL, morbidity, and mortality risk. However, by virtue of their age and low short-term CVD risk, AYA-CS do not meet traditional criteria for initiating cardiac rehabilitation (CR) and are less likely to receive treatments to reduce CVD risk. AYA-CS with stage B heart failure (SBHF): (1) are at high risk for subsequent HF/CVD death; (2) have lower cardiopulmonary fitness; and (3) are more likely to benefit from CVD risk factor management. Considering that AYA-CS have an estimated 33% prevalence of SBHF, this vulnerable cohort of cancer survivors represent an opportunity for intervention that is highly feasible and potentially impactful. Exercise is a preferred method for optimizing health and survival in PAYA-CS. However, we need models that safely and effectively deliver exercise interventions that meet the unique needs of this population. The cardio-oncology rehabilitation (CORE) model is an intervention that would provide AYA-CS with SBHF a supervised and home-based high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) exercise therapy, CVD risk factor modification, and behavioural support to reduce the risk of CVD. The primary objective of the HIMALAYAS study is to determine whether supervised CORE (Group 1A) improves cardiorespiratory fitness (VO2peak; primary outcome), cardiac function, CVD risk factors and biomarkers, and PROs at 6 months (primary timepoint) as well as 12 and 24 months compared to standard of care group control group (CON) in AYA-CS with SBHF.

The secondary objective of the study is to assess the ongoing behavioural support strategy based on the exercise guidelines for cancer survivors (i.e. 90 to 150 minutes of moderate to vigorous PA per week) on VO2peak, cardiac function, CVD risk factors and biomarkers, and PROs at 24 months compared to standard of care [CON] in AYA-CS with SBHF. Due to the COVID-19 pandemic, CORE intervention will involve a facility-based HIIT session and home-based HIIT session (described as "HIIT at Home") per week.

02

Conditions studied

  • Heart Failure
  • Cardiotoxicity
  • Cancer

Keywords

  • Adolescents and Young Adults
  • Exercise Therapy
  • Behavioral and Peer Support
  • Cardiac Rehabilitation
  • Cancer Survivor
03

In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 336 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Browse University Health Network, Toronto studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Be a PAYA-CS, defined as ≤39 years of age at the time of cancer diagnosis;
  2. Be 18-45 years of age at the time of enrolment;
  3. Received cancer treatment(s) with known cardiovascular risks (e.g., anthracyclines, trastuzumab, radiotherapy, platinum-based agents, vascular endothelial growth factor inhibitors, tyrosine kinase inhibitors);
  4. Be cancer-free at the time of enrollment;

  5. Stage B Heart Failure (SBHF)

    • In patients with availability of pre-treatment imaging:

      • ≥10% decrease in at post-treatment compared to pre-treatment
      • ≥15% decrease in GLS at post-treatment compared to pre-treatment

    • No pre-treatment imaging:

      • LVEF ≤53% in women/51% in men
      • GLS >-18%
      • Left ventricular hypertrophy (LV mass/body surface area: >95 g/m2 for women or >115 g/m2 for men)
      • Concentric remodelling (>0.42 relative wall thickness)
      • Diastolic dysfunction (≥ grade 1)
      • BNP ≥35pg/ml or NT-proBNP ≥125pg/ml

Exclusion criteria

Exclusion Criteria:

  1. Have an absolute or unresolved relative to exercise according to the American College of Sports Medicine guidelines;
  2. Have an untreated physical or mental health concern that precludes safe and effective exercise participation;
  3. Have established CVD (excluding mildly reduced as described above);
  4. Be pregnant at time of recruitment;
  5. Be currently engaging in frequent high-intensity exercise (>1 high-intensity exercise session per week);
  6. Have substantial barriers to participating, including (1) living too far from study centre or (2) being unable or willing to comply with the study protocol.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
336 participants (estimated)

Study arms

  • Experimental
    Cardio-Oncology Rehabilitation (CORE)

    Participants in the CORE group will have 1. A personalized, supervised exercise program ((in-person at intuition and virtual/ homebased exercises) 2. CV risk factor management, 3. behavioural support for the first 6 months. The behavioural support will continue for CORE participants from months 7-24. Behavioural support includes professionally guided and peer-enhanced exercise behavioural support based on behaviour change stage theories. CORE participants will be provided a wrist-worn heart and physical activity monitor to use throughout the 24-month observation period.

    Behavioral: Cardio-oncology Rehabilitation (CORE)

  • No intervention
    Standard of Care (CON)

    Participants in the CON group will receive standard medical care and physical activity will be monitored by a wrist-worn activity tracker for 2 years.

Interventions

  • BehavioralCardio-oncology Rehabilitation (CORE)

    Exercise therapy, CVD risk factor management for the first 6 months (as per current standards in CR models) and behavioural support for the entire 2-year intervention period

06

What researchers measure

Primary outcomes

  1. Cardiorespiratory fitness

    Assessed via cardiopulmonary exercise test and quantified as VO2peak

    Time frame: Baseline to 6-month follow-up (Primary RCT)

Secondary outcomes

  1. Cardiorespiratory fitness

    Assessed via cardiopulmonary exercise test and quantified as VO2peak

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  2. Ventilatory threshold

    Estimated using the V-slope method and according to the following criteria: i) an exaggerated response in the volume of carbon-dioxide (i.e., VCO2) relative to the volume of oxygen (i.e., VO2), and ii) the first identifiable break-point in in the minute ventilation (i.e., VE/VO2 vs work rate relationship).

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  3. Ventilatory threshold

    Estimated using the V-slope method and according to the following criteria: i) an exaggerated response in the volume of carbon-dioxide (i.e., VCO2) relative to the volume of oxygen (i.e., VO2), and ii) the first identifiable break-point in in the minute ventilation (i.e., VE/VO2 vs work rate relationship).

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  4. Anaerobic threshold

    Estimated according to the three-criterion discrimination technique: i) an excess VCO2 response relative to the VO2 response identified per the modified V-slope criteria; ii) the VE/VO2 to VO2 relationship having been flat or decreasing begins to increase without returning to baseline; and iii) there is no reciprocal decrease in PETCO2 at the point where PETO2 starts to rise systematically.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  5. Anaerobic threshold

    Estimated according to the three-criterion discrimination technique: i) an excess VCO2 response relative to the VO2 response identified per the modified V-slope criteria; ii) the VE/VO2 to VO2 relationship having been flat or decreasing begins to increase without returning to baseline; and iii) there is no reciprocal decrease in PETCO2 at the point where PETO2 starts to rise systematically.

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  6. Post-exercise heart rate recovery

    One-minute HR recovery (HRR; an index of post-exercise parasympathetic reactivation) will be calculated as the HR-difference between peak exercise and following one minute of quiet standing on the treadmill immediately post-test.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  7. Post-exercise heart rate recovery

    One-minute HR recovery (HRR; an index of post-exercise parasympathetic reactivation) will be calculated as the HR-difference between peak exercise and following one minute of quiet standing on the treadmill immediately post-test.

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  8. Left ventricular ejection fraction (LVEF)

    Assessed via 2D and 3D echocardiography

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  9. Left ventricular ejection fraction (LVEF)

    Assessed via 2D and 3D echocardiography

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  10. Global longitudinal strain (GLS)

    Assessed via 2D echocardiography

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  11. Global longitudinal strain (GLS)

    Assessed via 2D echocardiography

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  12. Early (E) and late (A) diastolic mitral inflow velocities and deceleration time

    Assessed via echocardiography

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  13. Early (E) and late (A) diastolic mitral inflow velocities and deceleration time

    Assessed via echocardiography

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  14. Early diastolic mitral septal and lateral annular velocities (e')

    Assessed via tissue Doppler imaging (TDI)

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  15. Early diastolic mitral septal and lateral annular velocities (e')

    Assessed via tissue Doppler imaging (TDI)

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  16. TR velocity

    Assess via spectral Doppler

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  17. TR velocity

    Assess via spectral Doppler

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  18. Left atrial volume

    Assess via 2D echocardiography

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  19. Left atrial volume

    Assess via 2D echocardiography

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  20. Diastolic function - E/e' ratio

    Calculated using the average of the TDI septal and lateral annular velocities (e')

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  21. Diastolic function - E/e' ratio

    Calculated using the average of the TDI septal and lateral annular velocities (e')

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  22. Left ventricular hypertrophy

    Assessed via Devereux formula and quantified as LV mass/body surface area: \>95 g/m2 for women or \>115 g/m2 for men

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  23. Left ventricular hypertrophy

    Assessed via Devereux formula and quantified as LV mass/body surface area: \>95 g/m2 for women or \>115 g/m2 for men

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  24. Concentric cardiac remodeling

    Assessed as \>0.42 relative wall thickness

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  25. Concentric cardiac remodeling

    Assessed as \>0.42 relative wall thickness

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  26. Resting heart rate

    Measured with an average of 2 readings taken via ECG during the resting period during the cardiac screening procedures.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  27. Resting heart rate

    Measured with an average of 2 readings taken via ECG during the resting period during the cardiac screening procedures.

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  28. Resting systolic and diastolic blood pressure

    Calculated as average of 3 readings measured via automated sphygmomanometer per the Hypertension Canada guidelines.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  29. Resting systolic and diastolic blood pressure

    Calculated as average of 3 readings measured via automated sphygmomanometer per the Hypertension Canada guidelines.

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  30. Apolipoprotein B

    Assessed via blood serum sample

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  31. Apolipoprotein B

    Assessed via blood serum sample

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  32. Total cholesterol

    Assessed via blood serum sample

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  33. Total cholesterol

    Assessed via blood serum sample

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  34. Low density lipoprotein

    Assessed via blood serum sample

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  35. Low density lipoprotein

    Assessed via blood serum sample

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  36. High density lipoprotein

    Assessed via blood serum sample

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  37. High density lipoprotein

    Assessed via blood serum sample

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  38. Whole body insulin sensitivity

    Assessed via Matsuda index

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  39. Whole body insulin sensitivity

    Assessed via Matsuda index

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  40. Hepatic insulin sensitivity

    Assessed via homeostasis model assessment insulin resistance (HOMA-IR)

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  41. Hepatic insulin sensitivity

    Assessed via homeostasis model assessment insulin resistance (HOMA-IR)

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  42. Pancreatic beta-cell function

    Assessed via the insulin secretion-sensitivity index-2 (ISSI-2)

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  43. Pancreatic beta-cell function

    Assessed via the insulin secretion-sensitivity index-2 (ISSI-2)

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  44. Body mass index

    Calculated as body weight (kg) divided by height (m) squared

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  45. Body mass index

    Calculated as body weight (kg) divided by height (m) squared

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  46. Objective physical activity

    Objectively assessed via wrist-worn physical activity/heart rate monitor to measure the intensity and duration of all planned and unplanned exercise during the study period

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  47. Subjective physical activity

    Subjectively assessed via Godin Leisure Time Physical Activity Questionnaire and reported as moderate-to-vigorous intensity physical activity (MVPA)

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  48. Subjective physical activity

    Subjectively assessed via Godin Leisure Time Physical Activity Questionnaire and reported as moderate-to-vigorous intensity physical activity (MVPA)

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  49. Social support

    Measured using the Social Support Survey-Clinical (SSS-C) form, a 5-item survey designed to measure five dimensions of social support + a single item to assess cancer-specific social support.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  50. Social support

    Measured using the Social Support Survey-Clinical (SSS-C) form, a 5-item survey designed to measure five dimensions of social support + a single item to assess cancer-specific social support.

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  51. Exercise self-efficacy

    Measured using the Multidimensional Self-Efficacy for Exercise Scale (MSES) to measure three behavioural subdomains: task, scheduling, and coping

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  52. Exercise self-efficacy

    Measured using the Multidimensional Self-Efficacy for Exercise Scale (MSES) to measure three behavioural subdomains: task, scheduling, and coping

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  53. Anxiety

    Measured using the Generalized Anxiety Disorder (GAD-7), a 7-item inventory that assesses 2-week anxiety symptom frequency on a 0-3 scale, with higher scores reflecting higher symptom frequency. A cut-off of ≥10 indicates some degree of clinical anxiety.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  54. Anxiety

    Measured using the Generalized Anxiety Disorder (GAD-7), a 7-item inventory that assesses 2-week anxiety symptom frequency on a 0-3 scale, with higher scores reflecting higher symptom frequency. A cut-off of ≥10 indicates some degree of clinical anxiety.

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  55. Depression

    Measured using the Patient Health Questionnaire (PHQ-9), a 9-item inventory that assesses 2-week depressive symptom frequency on a 0-3 scale, with higher scores reflecting higher symptom frequency. The PHQ-9 has been validated in cancer survivors using a cut-off of ≥8 to indicate some degree of clinical depression.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  56. Depression

    Measured using the Patient Health Questionnaire (PHQ-9), a 9-item inventory that assesses 2-week depressive symptom frequency on a 0-3 scale, with higher scores reflecting higher symptom frequency. The PHQ-9 has been validated in cancer survivors using a cut-off of ≥8 to indicate some degree of clinical depression.

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  57. Health-related quality of life

    Measured using the Medical Outcomes Survey Short-Form (SF-12).

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  58. Health-related quality of life

    Measured using the Medical Outcomes Survey Short-Form (SF-12).

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

  59. Health service utilization

    Measured using the Health Service Utilization Inventory.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  60. Health service utilization

    Measured using the Health Service Utilization Inventory.

    Time frame: Baseline to 24-month follow-up (Primary and Secondary RCTs)

Other outcomes

  1. Therapeutic alliance

    Measured using the Working Alliance Inventory Short-Revised (WAI-SR) form.

    Time frame: Baseline to 6-month follow-up (Primary RCT)

  2. Testing Performance

    Defined as the percent of tests that achieve 'peak' termination criteria relative to the total number of tests completed across all time points

    Time frame: Study initiation to end of 66-month study period (Primary and Secondary RCTs)

  3. Serious and non-serious adverse events

    Defined as the number and frequency of testing-, intervention-, and non-intervention-related serious (i.e. Grade 3 to 5; NCI-CTCAE criteria) and non-serious (i.e. Grade 1 to 2; NCI-CTCAE criteria)

    Time frame: Study initiation to end of 66-month study period (Primary and Secondary RCTs)

  4. Exercise Adherence

    This variable applies only to CORE participants. Exercise adherence is defined as the relative dose intensity (i.e. the percent of total dose of exercise performed, relative to the total dose prescribed) and quantified according to metabolic equivalents.

    Time frame: Study initiation to end of 48-month phase I intervention period (Primary RCT - CORE participants)

  5. Medication Compliance

    Defined as the percent of pharmaceutical doses taken based on the total number of doses prescribed (applicable only to those that are provided pharmaceutical therapy for CVD risk factor modification)

    Time frame: Study initiation to end of 48-month phase I intervention period (Primary RCT - CORE participants)

  6. Behavioural Compliance

    Defined as the percent of behavioural support resources accessed, based on the number recommended (one per month)

    Time frame: Study initiation to end of 66-month study period (Primary RCTs - CORE participants)

  7. Oxygen utilization during HIIT

    Quantified as timepoint measures of oxygen utilization assessed via portable metabolic measurement system within the final 30 seconds of the warm-up, work and recovery periods, and the cool down during pre-specified high-intensity interval training sessions

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE substudy participants; Primary RCT)

  8. Power output during HIIT

    Quantified as power output (watts) assessed cycle ergometer within the final 30 seconds of the warm-up, work and recovery periods, and the cool down during pre-specified high-intensity interval training sessions

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

  9. Heart rate response during HIIT

    Quantified via heart rate monitor or single-lead ECG within the final 30 seconds of the warm-up, work and recovery periods, and the cool down during pre-specified high-intensity interval training sessions

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

  10. Energy expenditure during HIIT

    Quantified as total metabolic equivalent of task following HIIT sessions

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

  11. Perceived exertion during HIIT

    Assessed via rating of perceived exertion scale (6-20) within the final 30 seconds of the warm-up, work and recovery periods, and the cool down during pre-specified high-intensity interval training sessions

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

  12. Felt arousal during HIIT

    Affective arousal is evaluated via the felt arousal scale that assesses energy/arousal level on a scale of 1 (low arousal) to 6 (high arousal) within the final 30 seconds of the warm-up, work and recovery periods, and the cool down during pre-specified HIIT sessions

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

  13. Feeling affect during HIIT

    The feeling scale is used to assess affective valence (pleasure/displeasure; feeling good/bad) on a scale of -5 (vey bad) to +5 (very good) within the final 30 seconds of the warm-up, work and recovery periods, and the cool down during pre-specified high-intensity interval training sessions

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

  14. Resilience

    Measured using the Brief Relilience Scale (BRS), a 6-item inventory that assesses recovery, resistance, adaptation, and thriving.

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

  15. Stress

    Measured using two items based on the Canadian Community Health Survey assessing the average daily stress experienced that day and over the past week.

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

  16. Feeling states

    Assessed via ecological momentary assessments using brief reports completed 6 times a day on intervention weeks 1, 7, 16, 22, four weeks post intervention, and 26 weeks post intervention

    Time frame: Study initiation to end of 48-month phase I intervention period (CORE sub-study participants; Primary RCT)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2024 (actual). Primary completion is estimated for Sep 2026, 32 months after the start.

Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 32 months is above that.

Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2021
First posted
Aug 27, 2021
StartActual
Jan 1, 2024
Primary completionEst.
Sep 2026
CompletionEst.
Mar 2027
Last update
Nov 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05023785
Lead sponsor
University Health Network, Toronto
Collaborators
Centre hospitalier de l'Université de Montréal (CHUM), Queen Elizabeth II Health Sciences Centre, Alberta Health services, Vancouver General Hospital, Université de Montréal, Dalhousie University, University of Alberta, University of British Columbia, University of Toronto
Responsible party
Sponsor
First posted
Aug 27, 2021
Start date
Jan 1, 2024
Primary completion
Sep 2026 (estimated)
Completion
Mar 2027 (estimated)
Last update
Nov 26, 2025

Study contacts

Paaladinesh Thavendiranathan, MD
Contact
dinesh.thavendiranathan@uhn.ca
416-340-5326
Nilina Mohabir, MSc
Contact
nilina.mohabir@uhn.ca
437-677-7491

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Heart Failure →

Other studies from this sponsor

University Health Network, Toronto →

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