Cardiovascular DiseasesT-REXI-CRNCT07908810
Threshold-Based Versus Range-Based Exercise Intensity Prescription in Cardiac Rehabilitation
A study testing Threshold-Based Aerobic Exercise Intensity Prescription and Range-Based Aerobic Exercise Intensity Prescription in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by Hasselt University at 9 sites in Belgium.
Trial summary
Cardiac rehabilitation is an important part of the treatment of patients with cardiovascular disease. Supervised aerobic exercise improves physical fitness, functional capacity, and quality of life. However, the most effective method for prescribing exercise intensity during cardiac rehabilitation remains uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Cardiac Rehabilitation
- What is being tested?
- Threshold-Based Aerobic Exercise Intensity Prescription and Range-Based Aerobic Exercise Intensity Prescription
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 9 sitesBelgium
- Study dates
- Apr 2027to Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Referred to and eligible for participation in a CR programme according to standard clinical practice.
- Diagnosis of cardiovascular disease, including but not limited to coronary artery disease, chronic heart failure, or other indications for CR.
- Ability to perform CPET safely, as determined by the treating physician.
- Baseline CPET allowing identification of both the first ventilatory threshold (VT1) and the second ventilatory threshold (VT2), with corresponding heart rate values available for exercise prescription.
- Ability to understand the study procedures and provide written informed consent.
- VT1 and VT2 will be identified locally by the clinical team performing the CPET, according to routine practice at each participating centre. Participants in whom either threshold cannot be identified will not proceed to randomisation.
Who cannot join
- Contraindications to exercise testing or training according to established clinical guidelines.
- Foreseeable prolonged interruptions or planned interventions during the 15-week intervention period that, in the investigator's judgement, are expected to substantially limit participation in the supervised exercise programme.
- Cardiac rhythm or device-related conditions that prevent reliable heart rate-based exercise prescription during exercise (e.g. non-sinus rhythm such as atrial fibrillation, pacemaker-dependent heart-rate response).
- Heart-rate reserve (HRR) <35 bpm on baseline CPET, considered insufficient for practical implementation of heart rate-based exercise prescription.
- Any medical, physical, or cognitive condition that, in the opinion of the investigator, would preclude safe participation in the study or adherence to the rehabilitation programme.
- Participation in another interventional study that may interfere with the outcomes of this trial.
- The HRR criterion is a study-specific operational criterion intended to ensure a sufficient overall heart-rate range for practical implementation of heart rate-based exercise prescription. In the range-based comparator arm, an HRR of ≥35 bpm corresponds to a prescribed heart-rate interval of approximately 10 bpm or more between 40% and 69% HRR.
- These criteria are designed to reflect routine clinical practice while ensuring safe and appropriate application of the exercise prescription strategies under investigation.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Belgium9 sites
Erasmus Hospital (Université Libre de Bruxelles)
Brussels, Brussels Capital
Grand Hôpital de Charleroi (GHdC)
Charleroi, Hainaut
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerp
Jessa Ziekenhuis
Hasselt, Limburg
Sint-Franciskusziekenhuis
Heusden-Zolder, Limburg
Centre Hospitalier Universitaire de Liège (CHU Liège, site Ourthe-Amblève)
Liège, Liège
Clinique Saint-Luc Bouge
Namur, Namur
AZ Delta
Roeselare, West Flanders
AZ Vesalius
Tongeren, Limburg
About this study
Official title: A Pragmatic, Multicentre, Parallel-Group, Superiority Randomised Controlled Trial Comparing Threshold-Based Versus Guideline-Recommended Range-Based Aerobic Exercise Prescription for Improving Cardiorespiratory Fitness in Patients Undergoing Cardiac Rehabilitation
Cardiac rehabilitation is an important part of the treatment of patients with cardiovascular disease. Supervised aerobic exercise improves physical fitness, functional capacity, and quality of life. However, the most effective method for prescribing exercise intensity during cardiac rehabilitation remains uncertain.
The T-REXI-CR trial aims to determine whether prescribing aerobic exercise intensity based on individual ventilatory thresholds leads to greater improvements in functional capacity than the guideline-recommended approach based on heart rate reserve.
Read more
This pragmatic, multicentre, randomised controlled trial will compare two exercise intensity prescription strategies in patients participating in cardiac rehabilitation programmes in Belgium.
Participants will be randomly assigned to one of two groups:
- Threshold-based prescription: Exercise intensity will be individually prescribed using the first and second ventilatory thresholds (VT1 and VT2) identified during cardiopulmonary exercise testing.
- Range-based prescription: Exercise intensity will be prescribed using the guideline-recommended range of 40-69% of heart rate reserve.
Both groups will participate in a 15-week supervised aerobic exercise programme, targeting 40 exercise sessions. The programmes will follow the same training structure and progression principles, differing primarily in the method used to determine exercise intensity.
The study will assess whether threshold-based exercise prescription provides additional benefits compared with conventional range-based prescription, with the aim of informing clinical practice and improving the delivery of cardiac rehabilitation.
Read the detailed description
BACKGROUND AND RATIONALE
Exercise-based cardiac rehabilitation is a cornerstone of secondary cardiovascular prevention. Although the benefits of aerobic exercise training are well established, uncertainty remains regarding the optimal method for individualising exercise intensity.
Current guidelines commonly recommend prescribing aerobic exercise intensity using predefined percentages of heart rate reserve (HRR). However, these percentage-based ranges may not accurately reflect individual physiological responses to exercise, particularly in patients with cardiovascular disease.
An alternative approach is to prescribe exercise intensity according to ventilatory thresholds identified during cardiopulmonary exercise testing (CPET). The first ventilatory threshold (VT1) and second ventilatory threshold (VT2) provide individual physiological reference points for defining exercise intensity domains. This approach may improve the precision of exercise prescription and potentially optimise training adaptations.
Despite the physiological rationale supporting threshold-based exercise prescription, evidence from large, pragmatic randomised controlled trials comparing this strategy with guideline-recommended range-based prescription in routine cardiac rehabilitation remains limited.
STUDY OBJECTIVE
The T-REXI-CR trial is designed to evaluate whether threshold-based aerobic exercise intensity prescription is superior to guideline-recommended HRR-based prescription for improving functional capacity in patients undergoing cardiac rehabilitation.
STUDY APPROACH
The study is designed as a pragmatic, multicentre, parallel-group, superiority randomised controlled trial conducted within routine cardiac rehabilitation services in Belgium.
Both study groups will receive supervised aerobic exercise training within a common 15-week programme, with a target of 40 sessions. Exercise prescriptions will be centrally generated and will follow standardised progression principles. The main difference between groups will be the method used to define individual exercise intensity boundaries.
The study will evaluate changes in functional capacity, alongside patient-reported health outcomes and other clinically relevant measures. Assessments will be performed at baseline, approximately four months, and eight months.
CLINICAL RELEVANCE
Both exercise prescription strategies are already used in clinical practice and are compatible with the Belgian cardiac rehabilitation system. By directly comparing these approaches under routine clinical conditions, the trial aims to provide evidence to support exercise prescription decisions and inform future cardiac rehabilitation recommendations.
- Conditions
- Cardiovascular Diseases, Cardiac Rehabilitation
- Being tested
- Threshold-Based Aerobic Exercise Intensity Prescription, Range-Based Aerobic Exercise Intensity Prescription
- Keywords
- Exercise Prescription, Exercise Intensity, Cardiac Rehabilitation, Cardiopulmonary Exercise Testing, Ventilatory Thresholds, Heart Rate Reserve, Aerobic Exercise Training, Functional Capacity, Randomized Controlled Trial
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold-Based Aerobic Exercise Intensity PrescriptionOther
Aerobic exercise intensity is individually prescribed according to the first and second ventilatory thresholds (VT1 and VT2) identified during baseline CPET. These thresholds are used to establish individualised heart rate training boundaries. Exercise prescriptions are centrally generated and follow a common FITT-VP framework, including predefined progression principles. Training is delivered within routine supervised cardiac rehabilitation, up to three sessions per week over 15 weeks, with a target of 40 sessions. The main aerobic training phase lasts 25-35 minutes per session, excluding warm-up and cool-down.
Range-Based Aerobic Exercise Intensity PrescriptionOther
Aerobic exercise intensity is individually prescribed using the guideline-recommended range of 40-69% of heart rate reserve (HRR), calculated from resting and peak heart rates obtained during baseline CPET. Exercise prescriptions are centrally generated and follow the same FITT-VP framework and predefined progression principles as the threshold-based group. Training is delivered within routine supervised cardiac rehabilitation, up to three sessions per week over 15 weeks, with a target of 40 sessions. The main aerobic training phase lasts 25-35 minutes per session, excluding warm-up and cool-down.
| Study group | Role | What they receive |
|---|---|---|
| Threshold-Based Exercise Prescription | Experimental | Participants allocated to this group will receive an individualised aerobic exercise prescription based on the first and second ventilatory thresholds (VT1 and VT2) determined during cardiopulmonary exercise testing (CPET). Exercise intensity will be prescribed using heart rate boundaries corresponding to these physiological thresholds. Participants will follow a 15-week supervised cardiac rehabilitation programme, targeting 40 exercise sessions, with centrally generated prescriptions and standardised progression principles. Receives: Other: Threshold-Based Aerobic Exercise Intensity Prescription |
| Range-Based Exercise Prescription | Active comparator | Participants allocated to this group will receive an individualised aerobic exercise prescription based on the guideline-recommended range of 40-69% of heart rate reserve (HRR), calculated using resting and peak heart rates obtained during CPET. Participants will follow the same 15-week supervised cardiac rehabilitation programme, targeting 40 exercise sessions, with centrally generated prescriptions and standardised progression principles. Receives: Other: Range-Based Aerobic Exercise Intensity Prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Peak Oxygen Uptake (VO2peak) From Baseline to 4 Months
The primary outcome is the change in peak oxygen uptake (VO2peak), expressed in mL/kg/min, from baseline to 4 months.
VO2peak will be measured using symptom-limited cardiopulmonary exercise testing (CPET) according to standardised procedures. Change will be calculated as the 4-month value minus the baseline value. The primary comparison will assess the between-group difference in mean change in VO2peak.
Measured: Baseline and 4 months (±1 week)
Secondary outcomes (6)
Change in Peak Oxygen Uptake (VO2peak) From Baseline to 8 Months
Change in peak oxygen uptake (VO2peak), expressed in mL/kg/min, measured by cardiopulmonary exercise testing (CPET). Change will be calculated as the 8-month value minus the baseline value. The between-group difference in mean change will be evaluated to assess the sustainability of the intervention effect.
Measured: Baseline and 8 months (±1 week)
Proportion of Participants Achieving a Clinically Meaningful Improvement in VO2peak
Proportion of participants achieving an increase in VO2peak of at least 1 mL/kg/min compared with baseline, as measured by CPET. Participants will be classified as responders or non-responders at each follow-up assessment. The proportion of responders will be compared between treatment groups.
Measured: Baseline, 4 months (±1 week), and 8 months (±1 week)
Change in Disease-Specific Quality of Life Assessed by HeartQoL
Change in disease-specific health-related quality of life measured using the HeartQoL questionnaire. HeartQoL is a validated patient-reported outcome instrument for patients with cardiovascular disease. Scores range from 0 to 3, with higher scores indicating better quality of life. Changes from baseline will be compared between treatment groups at 4 and 8 months.
Measured: Baseline, 4 months (±1 week), and 8 months (±1 week)
Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Change in health-related quality of life measured using the EQ-5D-5L questionnaire. The instrument assesses five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses will be used to derive an EQ-5D-5L health utility index score using the applicable value set. Changes from baseline will be compared between treatment groups at 4 and 8 months.
Measured: Baseline, 4 months (±1 week), and 8 months (±1 week)
Adherence to Supervised Exercise Training (key secondary outcome)
Adherence to supervised exercise training will be calculated as the percentage of supervised exercise sessions attended relative to the total number of sessions individually prescribed or scheduled during the 15-week intervention period. Data will be obtained from routine cardiac rehabilitation attendance records and the electronic case report form (eCRF). The target of 40 sessions will not be used as a fixed denominator, as the number of prescribed or scheduled sessions may vary between participants.
Measured: Throughout the 15-week supervised intervention period (assessed at 4 months)
Number of Supervised Exercise Sessions Attended
Total number of supervised aerobic exercise training sessions attended during the 15-week cardiac rehabilitation programme, obtained from routine attendance records and the electronic case report form (eCRF). This measure represents treatment exposure and will be summarised and compared between treatment groups.
Measured: Throughout the 15-week supervised intervention period (assessed at 4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startApr 2027 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- This is a pragmatic, multicentre, two-arm, parallel-group, superiority randomised controlled trial. Participants will be individually randomised (1:1) to receive either threshold-based aerobic exercise intensity prescription, using ventilatory thresholds (VT1 and VT2), or guideline-recommended range-based prescription, using 40-69% of heart rate reserve. Both groups will follow the same 15-week supervised cardiac rehabilitation programme, with centrally generated exercise prescriptions and standardised progression principles. Participants will remain in their allocated group throughout the intervention, with no crossover.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, PT, PhD, Full Professor, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908810
- Sponsor's protocol ID
- UH-2026-T-REXI-CR
- Other IDs
- KCE251578, 005265
- Acronym
- T-REXI-CR
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) may be shared in pseudonymised form after database lock and completion of the study, in accordance with the Research Agreement between the Sponsor (Hasselt University) and the Belgian Health Care Knowledge Centre (KCE). Upon request, KCE may receive the pseudonymised study dataset for non-commercial research and public health-related purposes. Further access by eligible institutions or researchers will be subject to applicable contractual arrangements, data protection requirements, and relevant approvals under the General Data Protection Regulation (GDPR). Directly identifiable participant information will not be included in the shared study dataset.
Publications
Hansen D, Junior GC, Milani JGPO, Milani M, Gojevic T, Machado FVC, Kambic T, Eijsvogels TMH, Bonifazi M, Dendale P, D'Ascenzi F. Advancing Aerobic Exercise Training Intensity Prescription in Health and Disease Beyond Standard Recommendations: A Call to Action. Sports Med. 2025 Sep;55(9):2111-2135. doi: 10.1007/s40279-025-02272-9. Epub 2025 Jul 4.
PubMed 40613962Milani JGPO, Milani M, Machado FVC, Wilhelm M, Marcin T, D'Ascenzi F, Cavigli L, Keytsman C, Falter M, Bonnechere B, Meesen R, Braga F, Cipriano GFB, Cornelissen V, Verboven K, Cipriano Junior G, Hansen D. Accurate prediction equations for ventilatory thresholds in cardiometabolic disease when gas exchange analysis is unavailable: development and validation. Eur J Prev Cardiol. 2024 Nov 18;31(16):1914-1924. doi: 10.1093/eurjpc/zwae149.
PubMed 38636093Milani JGPO, Milani M, D'Ascenzi F, Braga F, da Silveira AD, Cipriano GFB, Machado FVC, Wilhelm M, Marcin T, Cavigli L, Keytsman C, Falter M, Cornelissen V, Verboven K, Hansen D, Cipriano Junior G. Cardiorespiratory Exercise Intensity Prescription in Cardiovascular Rehabilitation: Do Updated Guideline Recommendations Reflect Real Individual Effort Responses? Eur J Prev Cardiol. 2026 Jun 10:zwag311. doi: 10.1093/eurjpc/zwag311. Online ahead of print.
PubMed 42267913Meyler SJR, Swinton PA, Bottoms L, Dalleck LC, Hunter B, Sarzynski MA, Wellsted D, Williams CJ, Muniz-Pumares D. Changes in Cardiorespiratory Fitness Following Exercise Training Prescribed Relative to Traditional Intensity Anchors and Physiological Thresholds: A Systematic Review with Meta-analysis of Individual Participant Data. Sports Med. 2025 Feb;55(2):301-323. doi: 10.1007/s40279-024-02125-x. Epub 2024 Nov 13.
PubMed 39538060Wolpern AE, Burgos DJ, Janot JM, Dalleck LC. Is a threshold-based model a superior method to the relative percent concept for establishing individual exercise intensity? a randomized controlled trial. BMC Sports Sci Med Rehabil. 2015 Jul 4;7:16. doi: 10.1186/s13102-015-0011-z. eCollection 2015.
PubMed 26146564Back M, Wilhelm M, Marcin T, Machado FVC, Sandberg A, Buccheri S, Castro Conde A, Czapla M, De Rosa S, Gibson I, Gombosova A, Korzh O, La Rovere MT, Locati ET, Masip J, Norekval TM, Novo G, Pedretti RFE, Semb AG, Siller-Matula JM, Ski CF, Sundermann SH, Taylor RS, Veltrop RJA, Hansen D; ESC Guidelines Advisory Group. 2026 ESC Guidelines on cardiac rehabilitation. Eur Heart J. 2026 Aug 28:ehag099. doi: 10.1093/eurheartj/ehag099. Online ahead of print. No abstract available.
PubMed 42661418
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic, Multicentre, Parallel-Group, Superiority Randomised Controlled Trial Comparing Threshold-Based Versus Guideline-Recommended Range-Based Aerobic Exercise Prescription for Improving Cardiorespiratory Fitness in Patients Undergoing Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT07908810
- Acronym / sponsor ID
- T-REXI-CR / UH-2026-T-REXI-CR
- Conditions
- Cardiovascular Diseases, Cardiac Rehabilitation
- Keywords
- Exercise Prescription, Exercise Intensity, Cardiac Rehabilitation, Cardiopulmonary Exercise Testing, Ventilatory Thresholds, Heart Rate Reserve, Aerobic Exercise Training, Functional Capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- Apr 2027 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 2 Nov 2026 (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.
Cardiac rehabilitation is an important part of the treatment of patients with cardiovascular disease. Supervised aerobic exercise improves physical fitness, functional capacity, and quality of life. However, the most effective method for prescribing exercise intensity during cardiac rehabilitation remains uncertain.
The T-REXI-CR trial aims to determine whether prescribing aerobic exercise intensity based on individual ventilatory thresholds leads to greater improvements in functional capacity than the guideline-recommended approach based on heart rate reserve.
This pragmatic, multicentre, randomised controlled trial will compare two exercise intensity prescription strategies in patients participating in cardiac rehabilitation programmes in Belgium.
Participants will be randomly assigned to one of two groups:
- Threshold-based prescription: Exercise intensity will be individually prescribed using the first and second ventilatory thresholds (VT1 and VT2) identified during cardiopulmonary exercise testing.
- Range-based prescription: Exercise intensity will be prescribed using the guideline-recommended range of 40-69% of heart rate reserve.
Both groups will participate in a 15-week supervised aerobic exercise programme, targeting 40 exercise sessions. The programmes will follow the same training structure and progression principles, differing primarily in the method used to determine exercise intensity.
The study will assess whether threshold-based exercise prescription provides additional benefits compared with conventional range-based prescription, with the aim of informing clinical practice and improving the delivery of cardiac rehabilitation.
Detailed description
BACKGROUND AND RATIONALE
Exercise-based cardiac rehabilitation is a cornerstone of secondary cardiovascular prevention. Although the benefits of aerobic exercise training are well established, uncertainty remains regarding the optimal method for individualising exercise intensity.
Current guidelines commonly recommend prescribing aerobic exercise intensity using predefined percentages of heart rate reserve (HRR). However, these percentage-based ranges may not accurately reflect individual physiological responses to exercise, particularly in patients with cardiovascular disease.
An alternative approach is to prescribe exercise intensity according to ventilatory thresholds identified during cardiopulmonary exercise testing (CPET). The first ventilatory threshold (VT1) and second ventilatory threshold (VT2) provide individual physiological reference points for defining exercise intensity domains. This approach may improve the precision of exercise prescription and potentially optimise training adaptations.
Despite the physiological rationale supporting threshold-based exercise prescription, evidence from large, pragmatic randomised controlled trials comparing this strategy with guideline-recommended range-based prescription in routine cardiac rehabilitation remains limited.
STUDY OBJECTIVE
The T-REXI-CR trial is designed to evaluate whether threshold-based aerobic exercise intensity prescription is superior to guideline-recommended HRR-based prescription for improving functional capacity in patients undergoing cardiac rehabilitation.
STUDY APPROACH
The study is designed as a pragmatic, multicentre, parallel-group, superiority randomised controlled trial conducted within routine cardiac rehabilitation services in Belgium.
Both study groups will receive supervised aerobic exercise training within a common 15-week programme, with a target of 40 sessions. Exercise prescriptions will be centrally generated and will follow standardised progression principles. The main difference between groups will be the method used to define individual exercise intensity boundaries.
The study will evaluate changes in functional capacity, alongside patient-reported health outcomes and other clinically relevant measures. Assessments will be performed at baseline, approximately four months, and eight months.
CLINICAL RELEVANCE
Both exercise prescription strategies are already used in clinical practice and are compatible with the Belgian cardiac rehabilitation system. By directly comparing these approaches under routine clinical conditions, the trial aims to provide evidence to support exercise prescription decisions and inform future cardiac rehabilitation recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pragmatic, multicentre, two-arm, parallel-group, superiority randomised controlled trial. Participants will be individually randomised (1:1) to receive either threshold-based aerobic exercise intensity prescription, using ventilatory thresholds (VT1 and VT2), or guideline-recommended range-based prescription, using 40-69% of heart rate reserve. Both groups will follow the same 15-week supervised cardiac rehabilitation programme, with centrally generated exercise prescriptions and standardised progression principles. Participants will remain in their allocated group throughout the intervention, with no crossover.
| Arm | Type | Receives |
|---|---|---|
| Threshold-Based Exercise Prescription | Experimental | Other: Threshold-Based Aerobic Exercise Intensity PrescriptionParticipants allocated to this group will receive an individualised aerobic exercise prescription based on the first and second ventilatory thresholds (VT1 and VT2) determined during cardiopulmonary exercise testing (CPET). Exercise intensity will be prescribed using heart rate boundaries corresponding to these physiological thresholds. Participants will follow a 15-week supervised cardiac rehabilitation programme, targeting 40 exercise sessions, with centrally generated prescriptions and standardised progression principles. |
| Range-Based Exercise Prescription | Active comparator | Other: Range-Based Aerobic Exercise Intensity PrescriptionParticipants allocated to this group will receive an individualised aerobic exercise prescription based on the guideline-recommended range of 40-69% of heart rate reserve (HRR), calculated using resting and peak heart rates obtained during CPET. Participants will follow the same 15-week supervised cardiac rehabilitation programme, targeting 40 exercise sessions, with centrally generated prescriptions and standardised progression principles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years.
- Referred to and eligible for participation in a CR programme according to standard clinical practice.
- Diagnosis of cardiovascular disease, including but not limited to coronary artery disease, chronic heart failure, or other indications for CR.
- Ability to perform CPET safely, as determined by the treating physician.
- Baseline CPET allowing identification of both the first ventilatory threshold (VT1) and the second ventilatory threshold (VT2), with corresponding heart rate values available for exercise prescription.
Key exclusion criteria (8 listed)
- Contraindications to exercise testing or training according to established clinical guidelines.
- Foreseeable prolonged interruptions or planned interventions during the 15-week intervention period that, in the investigator's judgement, are expected to substantially limit participation in the supervised exercise programme.
- Cardiac rhythm or device-related conditions that prevent reliable heart rate-based exercise prescription during exercise (e.g. non-sinus rhythm such as atrial fibrillation, pacemaker-dependent heart-rate response).
- Heart-rate reserve (HRR) <35 bpm on baseline CPET, considered insufficient for practical implementation of heart rate-based exercise prescription.
- Any medical, physical, or cognitive condition that, in the opinion of the investigator, would preclude safe participation in the study or adherence to the rehabilitation programme.
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 |
|---|---|---|
| Threshold-Based Aerobic Exercise Intensity PrescriptionAerobic exercise intensity is individually prescribed according to the first and second ventilatory thresholds (VT1 and VT2) identified during baseline CPET. These thresholds are used to establish individualised heart rate training boundaries. Exercise prescriptions are centrally generated and follow a common FITT-VP framework, including predefined progression principles. Training is delivered within routine supervised cardiac rehabilitation, up to three sessions per week over 15 weeks, with a target of 40 sessions. The main aerobic training phase lasts 25-35 minutes per session, excluding warm-up and cool-down. | Other | Threshold-Based Exercise Prescription |
| Range-Based Aerobic Exercise Intensity PrescriptionAerobic exercise intensity is individually prescribed using the guideline-recommended range of 40-69% of heart rate reserve (HRR), calculated from resting and peak heart rates obtained during baseline CPET. Exercise prescriptions are centrally generated and follow the same FITT-VP framework and predefined progression principles as the threshold-based group. Training is delivered within routine supervised cardiac rehabilitation, up to three sessions per week over 15 weeks, with a target of 40 sessions. The main aerobic training phase lasts 25-35 minutes per session, excluding warm-up and cool-down. | Other | Range-Based Exercise Prescription |
Primary outcome
Change in Peak Oxygen Uptake (VO2peak) From Baseline to 4 Months
Time frame: Baseline and 4 months (±1 week)
The primary outcome is the change in peak oxygen uptake (VO2peak), expressed in mL/kg/min, from baseline to 4 months. VO2peak will be measured using symptom-limited cardiopulmonary exercise testing (CPET) according to standardised procedures. Change will be calculated as the 4-month value minus the baseline value. The primary comparison will assess the between-group difference in mean change in VO2peak.
6 secondary outcomes
Change in Peak Oxygen Uptake (VO2peak) From Baseline to 8 Months
Time frame: Baseline and 8 months (±1 week)
Proportion of Participants Achieving a Clinically Meaningful Improvement in VO2peak
Time frame: Baseline, 4 months (±1 week), and 8 months (±1 week)
Change in Disease-Specific Quality of Life Assessed by HeartQoL
Time frame: Baseline, 4 months (±1 week), and 8 months (±1 week)
Change in Health-Related Quality of Life Assessed by EQ-5D-5L
Time frame: Baseline, 4 months (±1 week), and 8 months (±1 week)
Adherence to Supervised Exercise Training (key secondary outcome)
Time frame: Throughout the 15-week supervised intervention period (assessed at 4 months)
Number of Supervised Exercise Sessions Attended
Time frame: Throughout the 15-week supervised intervention period (assessed at 4 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 40613962Hansen D, Junior GC, Milani JGPO, Milani M, Gojevic T, Machado FVC, Kambic T, Eijsvogels TMH, Bonifazi M, Dendale P, D'Ascenzi F. Advancing Aerobic Exercise Training Intensity Prescription in Health and Disease Beyond Standard Recommendations: A Call to Action. Sports Med. 2025 Sep;55(9):2111-2135. doi: 10.1007/s40279-025-02272-9. Epub 2025 Jul 4.
- Background: PubMed 38636093Milani JGPO, Milani M, Machado FVC, Wilhelm M, Marcin T, D'Ascenzi F, Cavigli L, Keytsman C, Falter M, Bonnechere B, Meesen R, Braga F, Cipriano GFB, Cornelissen V, Verboven K, Cipriano Junior G, Hansen D. Accurate prediction equations for ventilatory thresholds in cardiometabolic disease when gas exchange analysis is unavailable: development and validation. Eur J Prev Cardiol. 2024 Nov 18;31(16):1914-1924. doi: 10.1093/eurjpc/zwae149.
- Background: PubMed 42267913Milani JGPO, Milani M, D'Ascenzi F, Braga F, da Silveira AD, Cipriano GFB, Machado FVC, Wilhelm M, Marcin T, Cavigli L, Keytsman C, Falter M, Cornelissen V, Verboven K, Hansen D, Cipriano Junior G. Cardiorespiratory Exercise Intensity Prescription in Cardiovascular Rehabilitation: Do Updated Guideline Recommendations Reflect Real Individual Effort Responses? Eur J Prev Cardiol. 2026 Jun 10:zwag311. doi: 10.1093/eurjpc/zwag311. Online ahead of print.
- Background: PubMed 39538060Meyler SJR, Swinton PA, Bottoms L, Dalleck LC, Hunter B, Sarzynski MA, Wellsted D, Williams CJ, Muniz-Pumares D. Changes in Cardiorespiratory Fitness Following Exercise Training Prescribed Relative to Traditional Intensity Anchors and Physiological Thresholds: A Systematic Review with Meta-analysis of Individual Participant Data. Sports Med. 2025 Feb;55(2):301-323. doi: 10.1007/s40279-024-02125-x. Epub 2024 Nov 13.
- Background: PubMed 26146564Wolpern AE, Burgos DJ, Janot JM, Dalleck LC. Is a threshold-based model a superior method to the relative percent concept for establishing individual exercise intensity? a randomized controlled trial. BMC Sports Sci Med Rehabil. 2015 Jul 4;7:16. doi: 10.1186/s13102-015-0011-z. eCollection 2015.
- Background: PubMed 42661418Back M, Wilhelm M, Marcin T, Machado FVC, Sandberg A, Buccheri S, Castro Conde A, Czapla M, De Rosa S, Gibson I, Gombosova A, Korzh O, La Rovere MT, Locati ET, Masip J, Norekval TM, Novo G, Pedretti RFE, Semb AG, Siller-Matula JM, Ski CF, Sundermann SH, Taylor RS, Veltrop RJA, Hansen D; ESC Guidelines Advisory Group. 2026 ESC Guidelines on cardiac rehabilitation. Eur Heart J. 2026 Aug 28:ehag099. doi: 10.1093/eurheartj/ehag099. Online ahead of print. No abstract available.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) may be shared in pseudonymised form after database lock and completion of the study, in accordance with the Research Agreement between the Sponsor (Hasselt University) and the Belgian Health Care Knowledge Centre (KCE). Upon request, KCE may receive the pseudonymised study dataset for non-commercial research and public health-related purposes. Further access by eligible institutions or researchers will be subject to applicable contractual arrangements, data protection requirements, and relevant approvals under the General Data Protection Regulation (GDPR). Directly identifiable participant information will not be included in the shared study dataset.
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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.
Dominique Hansen, PT, PhD, Full Professor principal investigator
Hasselt University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold-Based Aerobic Exercise Intensity Prescription and Range-Based Aerobic Exercise Intensity Prescription in people with Cardiovascular Diseases and Cardiac Rehabilitation, run by Hasselt University at 9 sites in Belgium.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Juliana G P O Milani, PT, PhD, Trial Coordinator (+32 11 269 311, juliana.milani@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Peak Oxygen Uptake (VO2peak) From Baseline to 4 Months (time frame: Baseline and 4 months (±1 week)). 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 NCT07908810, 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 2 Nov 2026.