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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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.

United Kingdom1 site
  • School of Sport and and Health Sciences

    Preston

Other trials in United Kingdom

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.

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 groups in NCT04114929
Study groupRoleWhat they receive
Threshold-BasedExperimentalPatients will be prescribed exercise based on ventilatory thresholds from a maximal cardiopulmonary exercise test
Receives: Other: Threshold-based Training
Standard CareActive comparatorPatients 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.

  1. Peak Oxygen Consumption Change

    Peak Oxygen Consumption as determined by a cardiopulmonary exercise test

    Measured: Baseline & 3 months

Secondary outcomes (1)
  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.

  1. First posted3 Oct 2019
  2. Study start1 Mar 2020
  3. Primary completion1 Nov 2021 (estimated)
  4. Study completion1 Aug 2022 (estimated)

Why it stopped: COVID-19

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will randomised either to threshold-based training or standard care
Masking
None (open label)
Enrolment
0 participants (actual)
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

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.

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