Cardiac RehabilitationNCT04114929
Is Threshold-based Training Superior in Cardiac Rehabilitation
A study testing Threshold-based Training in people with Cardiac Rehabilitation, run by University of Central Lancashire at 1 site in United Kingdom.
Trial summary
This study evaluates two methods of prescribing exercise intensity in a Phase IV cardiac rehabilitation programme. One method is using specific ventilatory markers and the other following standard care guidelines. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Threshold-based Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2020to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has read and understood the Patient Information Sheet
- Diagnosis of coronary heart disease (CHD) including myocardial infarction(MI), coronary artery bypass graft (CABG) surgery, elective percutaneous coronary intervention (PCI) or exertional angina.
- . Diagnosis of heart failure
- Aged between 18 and 85 years
- Absence of contraindications to exercise testing and training
- Clinically stable (symptoms and medication)
- Patient is able to and has given written informed consent
- Able to comply with guidelines for participation in exercise testing \& prescription
Who cannot join
- Clinically Unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is a Threshold Based Model a Superior Method at Improving Cardiorespiratory Fitness in Patients Attending Phase IV Cardiac Rehabilitation
This study evaluates two methods of prescribing exercise intensity in a Phase IV cardiac rehabilitation programme. One method is using specific ventilatory markers and the other following standard care guidelines.
Read the detailed description
Coronary heart disease (CHD) is one of the United Kingdom's (UK) biggest killers. In the UK alone 175,000 myocardial infarctions are recorded annually. While these numbers are significant advances in preventative therapy and medical treatment have contributed to an overall reduction in mortality in the UK. As such there is a growing need for effective secondary prevention. To lower the financial burden on the National Health Service (NHS), cardiac rehabilitation (CR) facilitates a systematic and multidisciplinary approach to secondary prevention aimed to improve functional capacity and health-related quality of life, lower rehospitalisation rates and reduce all-cause and cardiovascular mortality with exercise training being the cornerstones.
A 2016 Cochrane review found benefits of exercise-based CR for patients with coronary artery disease. Both cardiovascular mortality and hospital readmissions were reduced, when compared with a no-exercise control. However, in contrast to previous systematic reviews and meta-analyses, there was no significant reduction in risk of reinfarction or all-cause mortality. Further a recent systematic review and meta-analysis (2018) found no differences in outcomes between exercise-based CR and a no-exercise control at their longest follow-up period for: all-cause mortality or cardiovascular mortality. The authors also found a small reduction in hospital admissions of borderline statistical significance. One possible answer to the above findings is the under dosage of exercise intensity and duration in UK CR. A recent multicentre study of routine UK-based CR (current clinical practice) indicated that the 'exercise dose' within outpatient UK CR may be insufficient to meaningfully improve cardiorespiratory fitness (CRF) when compared with international programmes. Given the prognostic relevance of improving CRF and that exercise and physical activity has a 'dose-response' relationship with cardiovascular disease risk, these findings may explain why UK CR programmes do not appear to improve patient survival.
UK-based guidelines advocate a percentage range-based method for prescribing exercise intensity. However, there are a number of limitations of this method. The investigators and others have recently shown that prescribing exercise intensity using percentage heart rate reserve (%HRR) can lead to patients receiving different exercise training doses from what would be historically viewed as the same exercise training intervention. Prescribing exercise based on %HRR ignores the important role that metabolic perturbations play in stimulating physiological adaptation in response to exercise training. The ventilatory anaerobic threshold (VAT) is an important objective metabolic threshold that indicates when incrementally greater contributions from anaerobic metabolism are required to sustain further increases in workload. The VAT has been proposed as a minimum exercise training intensity that must be exceeded in order to improve aerobic fitness. Compelling data has shown that the occurrence of the VAT is patient-specific, and can occur at different percentage of a patient's HRR. Basing an exercise training programme on estimated, or even directly measured %HRR could therefore result in heart rate training zones being set either above, or below the VAT. Patients who are prescribed the 'same' exercise training programme based on %HRR could be exposed to different metabolic stimuli and therefore a different exercise training dose. This may explain why some patients appear to 'respond' to a treatment, whilst others may be classified as "non-responders." Prescribing exercise that can improve CRF for patients attending CR is essential, and greater consideration for how exercise is prescribed in a community-based setting is required.
Given the VAT is a significant threshold, with evidence reporting it to be a superior method, comparisons to the %HRR method are limited in clinical populations. As such the primary focus of the study is to compare the effectiveness of a threshold-based model (ventilatory threshold) versus a relative percent model (%HRR) for improving cardiorespiratory fitness in patient attending Phase IV community based cardiac rehabilitation.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Threshold-based Training, Standard Care
- Keywords
- ventilatory anaerobic threshold, Intensity, Exercise Dose, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Threshold-based TrainingOther
Specific ventilatory markers determined from a cardiopulmonary test and the correlating heart rate will be used to determine exercise intensity
Standard CareOther
Using the standard care cardiac rehabilitation guidelines exercise will be based on estimated heart rate maximum followed by the karvonan method to calculate 40-70% heart rate reserve
| Study group | Role | What they receive |
|---|---|---|
| Threshold-Based | Experimental | Patients will be prescribed exercise based on ventilatory thresholds from a maximal cardiopulmonary exercise test Receives: Other: Threshold-based Training |
| Standard Care | Active comparator | Patients will be prescribed exercise based on standard guidelines Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Oxygen Consumption Change
Peak Oxygen Consumption as determined by a cardiopulmonary exercise test
Measured: Baseline & 3 months
Secondary outcomes (1)
Health Related Quality of Life Change (EuroQoL EQ-5D)
Quality of Life as determined by the Health Related Quality of Life Questionnaire. The questionnaire five sections, mobility, self-care, usual activities, pain/discomfort and anxiety and depression. The scoring system is not displayed on the questionnaire however when evaluating runs in order of severity (0-4). A 0-100 scale follows where a patient will score their health status. 100 means the best health they can imagine and 0 means the worst
Measured: Baseline & 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Mar 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Aug 2022 (estimated)
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Patients will randomised either to threshold-based training or standard care
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Lancashire
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hull, Leeds Beckett University, Sheffield Hallam University
- Responsible party
- Principal investigator, Stefan Birkett, University of Central Lancashire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114929
- Sponsor's protocol ID
- UCentalLancashire
- Status last verified
- Nov 2022
- First submitted
- 28 Sep 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Threshold Based Model a Superior Method at Improving Cardiorespiratory Fitness in Patients Attending Phase IV Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT04114929
- Acronym / sponsor ID
- UCentalLancashire
- Conditions
- Cardiac Rehabilitation
- Keywords
- ventilatory anaerobic threshold, Intensity, Exercise Dose, Standard care
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID-19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Central LancashireUniversity, hospital or other
- Collaborators
- University of Hull, Leeds Beckett University, Sheffield Hallam University
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 3 Oct 2019 (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.
This study evaluates two methods of prescribing exercise intensity in a Phase IV cardiac rehabilitation programme. One method is using specific ventilatory markers and the other following standard care guidelines.
Detailed description
Coronary heart disease (CHD) is one of the United Kingdom's (UK) biggest killers. In the UK alone 175,000 myocardial infarctions are recorded annually. While these numbers are significant advances in preventative therapy and medical treatment have contributed to an overall reduction in mortality in the UK. As such there is a growing need for effective secondary prevention. To lower the financial burden on the National Health Service (NHS), cardiac rehabilitation (CR) facilitates a systematic and multidisciplinary approach to secondary prevention aimed to improve functional capacity and health-related quality of life, lower rehospitalisation rates and reduce all-cause and cardiovascular mortality with exercise training being the cornerstones.
A 2016 Cochrane review found benefits of exercise-based CR for patients with coronary artery disease. Both cardiovascular mortality and hospital readmissions were reduced, when compared with a no-exercise control. However, in contrast to previous systematic reviews and meta-analyses, there was no significant reduction in risk of reinfarction or all-cause mortality. Further a recent systematic review and meta-analysis (2018) found no differences in outcomes between exercise-based CR and a no-exercise control at their longest follow-up period for: all-cause mortality or cardiovascular mortality. The authors also found a small reduction in hospital admissions of borderline statistical significance. One possible answer to the above findings is the under dosage of exercise intensity and duration in UK CR. A recent multicentre study of routine UK-based CR (current clinical practice) indicated that the 'exercise dose' within outpatient UK CR may be insufficient to meaningfully improve cardiorespiratory fitness (CRF) when compared with international programmes. Given the prognostic relevance of improving CRF and that exercise and physical activity has a 'dose-response' relationship with cardiovascular disease risk, these findings may explain why UK CR programmes do not appear to improve patient survival.
UK-based guidelines advocate a percentage range-based method for prescribing exercise intensity. However, there are a number of limitations of this method. The investigators and others have recently shown that prescribing exercise intensity using percentage heart rate reserve (%HRR) can lead to patients receiving different exercise training doses from what would be historically viewed as the same exercise training intervention. Prescribing exercise based on %HRR ignores the important role that metabolic perturbations play in stimulating physiological adaptation in response to exercise training. The ventilatory anaerobic threshold (VAT) is an important objective metabolic threshold that indicates when incrementally greater contributions from anaerobic metabolism are required to sustain further increases in workload. The VAT has been proposed as a minimum exercise training intensity that must be exceeded in order to improve aerobic fitness. Compelling data has shown that the occurrence of the VAT is patient-specific, and can occur at different percentage of a patient's HRR. Basing an exercise training programme on estimated, or even directly measured %HRR could therefore result in heart rate training zones being set either above, or below the VAT. Patients who are prescribed the 'same' exercise training programme based on %HRR could be exposed to different metabolic stimuli and therefore a different exercise training dose. This may explain why some patients appear to 'respond' to a treatment, whilst others may be classified as "non-responders." Prescribing exercise that can improve CRF for patients attending CR is essential, and greater consideration for how exercise is prescribed in a community-based setting is required.
Given the VAT is a significant threshold, with evidence reporting it to be a superior method, comparisons to the %HRR method are limited in clinical populations. As such the primary focus of the study is to compare the effectiveness of a threshold-based model (ventilatory threshold) versus a relative percent model (%HRR) for improving cardiorespiratory fitness in patient attending Phase IV community based cardiac rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will randomised either to threshold-based training or standard care
| Arm | Type | Receives |
|---|---|---|
| Threshold-Based | Experimental | Other: Threshold-based TrainingPatients will be prescribed exercise based on ventilatory thresholds from a maximal cardiopulmonary exercise test |
| Standard Care | Active comparator | Other: Standard CarePatients will be prescribed exercise based on standard guidelines |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient has read and understood the Patient Information Sheet
- Diagnosis of coronary heart disease (CHD) including myocardial infarction(MI), coronary artery bypass graft (CABG) surgery, elective percutaneous coronary intervention (PCI) or exertional angina.
- . Diagnosis of heart failure
- Aged between 18 and 85 years
- Absence of contraindications to exercise testing and training
Key exclusion criteria (1 listed)
- Clinically Unstable
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 TrainingSpecific ventilatory markers determined from a cardiopulmonary test and the correlating heart rate will be used to determine exercise intensity | Other | Threshold-Based |
| Standard CareUsing the standard care cardiac rehabilitation guidelines exercise will be based on estimated heart rate maximum followed by the karvonan method to calculate 40-70% heart rate reserve | Other | Standard Care |
Primary outcome
Peak Oxygen Consumption Change
Time frame: Baseline & 3 months
Peak Oxygen Consumption as determined by a cardiopulmonary exercise test
1 secondary outcome
Health Related Quality of Life Change (EuroQoL EQ-5D)
Time frame: Baseline & 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
Related trials for Cardiac Rehabilitation
Not yet recruiting
King's Theory-Based Multicomponent Interventions in Heart Failure Patient Rehabilitation
Heart Failure, Cardiac Rehabilitation
Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
Recruiting
Impact of a Tailored Digital Intervention on Sedentary Behaviour and Physical Health in Long-term Cardiac Rehabilitation Patients
Cardiovascular Diseases (CVD), Coronary Disease
Not yet recruiting
Threshold-Based Versus Range-Based Exercise Intensity Prescription in Cardiac Rehabilitation
Cardiovascular Diseases, Cardiac Rehabilitation
Not yet recruiting
VWCR to Improve Cardiovascular Health and Outcomes Among Cardiac Patients: A Multicenter Randomized Clinical Trial Protocol (Destination Cardiac Rehab Study)
Heart Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Threshold-based Training in people with Cardiac Rehabilitation, run by University of Central Lancashire at 1 site in United Kingdom.
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 8 inclusion and 1 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: withdrawn, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Peak Oxygen Consumption Change (time frame: Baseline & 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.