Heart DiseaseNCT02376244
The Health Impact of High Intensity Exercise Training With Intervals During Cardiac Rehabilitation
A study testing High intensity interval training (HIIT) in people with Heart Disease and Heart Attacks, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Cardiac rehabilitation is a program designed to help patients regain good health through lifestyle change after a heart attack, heart surgery or other heart problems. Patients will take part in exercise sessions and education lessons, tailored to meet their personal needs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Disease, Heart Attacks
- What is being tested?
- High intensity interval training (HIIT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Jun 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- History of acute coronary syndromes, had a recent revascularization procedure
- History of stable heart failure or stable angina.
Who cannot join
- Unstable angina
- Systolic blood pressure of >200 mm Hg, or diastolic blood pressure >110 mm Hg (should be assessed on a case-by-case basis)
- Orthostatic blood pressure drop of >20 mm Hg with symptoms
- May have had the implantation of cardiac defibrillators (ICD)
- Synchronization devices or ventricular assist devices
- Have had a heart valve repair/replacement, a heart transplant, or grown-up congenital heart disease, critical aortic stenosis, acute systemic illness or fever, -
Show all 11Show fewer
- Uncontrolled atrial or ventricular arrhythmias, acute pericarditis or myocarditis
- Recent embolism, thrombophlebitis, resting S-T segment depression (>2 mm), uncontrolled diabetes (should be assessed in accordance with local protocol and on a case-by-case basis)
- Severe orthopedic conditions that would prohibit exercise
- Other metabolic conditions, such as acute thyroiditis, hypokalemia or hyperkalemia, hypovolemia, severe rejection (cardiac transplant recipients), triple A >4.5 cm (if under surveillance will need confirmation from vascular surgeon as long as blood pressure remains stable)
- Tachycardia >100 beats per minute at rest, or cataracts (may commence exercise after 6 weeks)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
About this study
Official title: A Randomised Controlled Trial on the Efficacy of High Intensity Interval Training Compared With Moderate Intensity Interval Training for Patients Undergoing Cardiac Rehabilitation
Cardiac rehabilitation is a program designed to help patients regain good health through lifestyle change after a heart attack, heart surgery or other heart problems. Patients will take part in exercise sessions and education lessons, tailored to meet their personal needs. The exercise training component of cardiac rehabilitation may be delivered as intervals of short intense sessions (also known as high intensity intervals) or the current standard care of longer but less intense sessions (moderate intense intervals). Both exercises have been shown to increase fitness levels and also prevent future risk of heart disease.
The purpose of this study is to determine the efficacy and safety of high intensity interval exercise training (HIIT) in patients who had a recent cardiac revascularization procedure or recovering from a heart attack, in comparison to current standard of moderate intensity exercise training in terms of their physical fitness and psychological well-being.
Read the detailed description
Cardiac rehabilitation is an eight week program designed to help patients regain good health through changed lifestyle after a possible heart attack, heart surgery or other heart problems. Patients will take part in exercise sessions and education lessons, tailored to meet their personal needs. The exercise training component of cardiac rehabilitation may be delivered as intervals of short intense sessions (also known as high intensity intervals) or the current standard care of longer but less intense sessions (moderate intense intervals). Both exercises have been shown to increase fitness levels and also prevent future risk of heart disease. Although there is some evidence to suggest that high intensity interval training produces better body muscles recovery and fitness during cardiac rehabilitation, many important health outcomes have not yet been determined. Such outcomes include the ability of the body to safely control blood pressure and heartbeat rate. Others include health-related quality of life and emotional well-being.
This study will explore whether there are any differences in health outcomes before and after the introduction of the intervention for patients undergoing high intensity interval exercise compared to those on moderate intensity interval exercise in terms of the recovery of the ability to control blood pressure and heartbeat rate, and also health-related quality of life and emotional well-being. In addition, patients' opinions will be sought regarding pain levels, the acceptability and the extent of enjoyment they get from each of the two types of exercise training.
For each patient, their exercise program will be designed to match their preferences and requirements. Some may prefer to work in a gym environment and so will have their program designed around this type of activity. Others may prefer to work in a group exercise circuit, with their program matched to what is available. When comparing the two types of exercise, everything will be kept the same; from the warm up and cool down, to the types of movements; the only thing that will change is the intensity of the exercise.
Before and after the eight week training program, patients will be asked to have an assessment to measure the effects that the exercise has on their body. Things like heart rate and blood pressure will be taken and they will also undergo a physical fitness test.
After the training, patients will complete questionnaires to establish their level of enjoyment of the program, how motivated they were to complete it. In addition, their quality of life and emotional well-being will be measured by completing questionnaires before and after the 8 weeks of the cardiac rehabilitation program. The investigators anticipate that a total of 46 patients will be recruited for the study over a period of 6 months. In the United Kingdom, it is believed that delivering an improved exercise training program has the potential to enhance patients' recovery from heart disease that may reduce the need for hospital services and therefore a better use of the National Health Service resources.
- Conditions
- Heart Disease, Heart Attacks
- Being tested
- High intensity interval training (HIIT), Standard care
- Keywords
- High intensity Interval Exercise training, Cardiac rehabilitation, cardiac revascularisation, Percutaneous coronary interventions, Cardiac surgery
- Medical subject headings
- Heart Diseases, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval training (HIIT)Other
Also called Group 1
Standard care cardiac rehabilitation classes, delivered at a higher exercise intensity
Standard careOther
Also called Group 2
Standard care cardiac rehabilitation according to current guidelines
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training (HIIT) | Experimental | Patients will undergo a 15-minute warm-up, followed by a 24-minute conditioning phase, and a 10-minute cool-down. The conditioning phase will include a combination of aerobic exercise (e.g. cycling or walking) and resistance exercise (e.g. squats, bicep curls). Patients will complete 5 intervals of 3 minutes with 2 minute rest periods interspersed. The intensity will correspond to 16-17 on the Borg 6-20 Rating of perceived exertion scale.
Patients will exercise once a week for 8 weeks. Receives: Other: High intensity interval training (HIIT) |
| Standard Care | Active comparator | Patients assigned to this group will participate in usual standard care of cardiac rehabilitation.
Commonly, patients will undergo a 15-minute warm-up, followed by a 24-minute conditioning phase, and a 10-minute cool-down. The conditioning phase will include a combination of aerobic exercise (e.g. cycling or walking) and resistance exercise (e.g. squats, bicep curls). Patients will complete 5 intervals of 3 minutes with 2 minute rest periods interspersed. The intensity will correspond to 11-15 on the Borg 6-20 Rating of perceived exertion scale.
Patients will exercise once a week for 8 weeks. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Heart Rate Variability (as measured by a hemodynamic monitoring system)
The primary outcome is the difference in heart rate variability between baseline and 8 weeks after the start of the intervention measured using finger photoplethysmography
Measured: Change from baseline in heart rate variability at 8 weeks after the start of the intervention
Secondary outcomes (5)
Changes in Baroreflex Sensitivity (as measured by a hemodynamic monitoring system)
This is the difference in heart rate variability between baseline and 8 weeks after the start of intervention measured using finger photoplethysmography
Measured: Change from baseline in baroreflex sensitivity at 8 weeks after the start of the intervention
Changes in Peak Oxygen Uptake (as measured by a submaximal exercise test)
Submaximal Cardiopulmonary Exercise Testing will be performed to measure changes in peak oxygen uptake between baseline and 8 weeks after the start of the intervention
Measured: Changes in peak oxygen uptake between baseline and 8 weeks after the start of intervention
Changes in Enjoyment of Exercise (as measured by a questionnaire)
Changes in pleasure and displeasure, affect, arousal between baseline and 8 weeks after the start of intervention will be assessed by using a "Feelings Scale", "Felt Arousal Scale", "Physical Activity Enjoyment Scale" respectively.
Measured: Changes in perception of enjoyment of exercise at between baseline and 8 weeks after the start of intervention
Changes in health-related Quality of Life (as measured by a questionnaire)
Changes in health-related quality of life between baseline and 8 weeks after the start of intervention will be measured by completion of MacNew Quality of Life questionnaires
Measured: Changes in health-related quality of life between baseline and 8 weeks after the start of intervention
Changes in Rating of Perceived Exertion (as measured by a scale)
Ratings of perceived exertion (RPE) allow the intensity of exercise to be determined subjectively on a scale of 6-20. Changes in RPE scales will be assessed at start of each workout as part of service protocol to gauge patient effort, fatigue and muscular discomfort and the differences between baseline and 8 weeks after start of intervention will be determined. At the end of each session, patients will be expected to submit an overall session RPE of how they perceived the entire exercise session (Kilpatrick et al. 2014).
Measured: Changes in the rating of perceived exertion between baseline and 8 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies 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
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Edge Hill University
- Responsible party
- Sponsor
- Investigators
- Alison C Welsh, Principal investigator, Edge Hill University and Liverpool Heart and Chest HospitalAdrian Roose, Principal investigator, Liverpool Heart and Chest HospitalJoseph Mills, Principal investigator, Liverpool Heart and Chest HospitalBashir Matata, Principal investigator, Liverpool Heart and Chest HospitalAdrian Midgley, Principal investigator, Edge Hill UniversityFelipe Cunha, Principal investigator, Edge Hill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376244
- Sponsor's protocol ID
- SP 006 - HIIT
- Status last verified
- Aug 2016
- First submitted
- 11 Feb 2015
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Munk PS, Butt N, Larsen AI. High-intensity interval exercise training improves heart rate variability in patients following percutaneous coronary intervention for angina pectoris. Int J Cardiol. 2010 Nov 19;145(2):312-314. doi: 10.1016/j.ijcard.2009.11.015. Epub 2009 Dec 5.
PubMed 19962772Guiraud T, Nigam A, Gremeaux V, Meyer P, Juneau M, Bosquet L. High-intensity interval training in cardiac rehabilitation. Sports Med. 2012 Jul 1;42(7):587-605. doi: 10.2165/11631910-000000000-00000.
PubMed 22694349Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available.
PubMed 11581152Currie KD, Rosen LM, Millar PJ, McKelvie RS, MacDonald MJ. Heart rate recovery and heart rate variability are unchanged in patients with coronary artery disease following 12 weeks of high-intensity interval and moderate-intensity endurance exercise training. Appl Physiol Nutr Metab. 2013 Jun;38(6):644-50. doi: 10.1139/apnm-2012-0354. Epub 2013 Jan 17.
PubMed 23724882
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on the Efficacy of High Intensity Interval Training Compared With Moderate Intensity Interval Training for Patients Undergoing Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT02376244
- Acronym / sponsor ID
- SP 006 - HIIT
- Conditions
- Heart Disease, Heart Attacks
- Keywords
- High intensity Interval Exercise training, Cardiac rehabilitation, cardiac revascularisation, Percutaneous coronary interventions, Cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Edge Hill University
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Mar 2015 (estimated)
- 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 a program designed to help patients regain good health through lifestyle change after a heart attack, heart surgery or other heart problems. Patients will take part in exercise sessions and education lessons, tailored to meet their personal needs. The exercise training component of cardiac rehabilitation may be delivered as intervals of short intense sessions (also known as high intensity intervals) or the current standard care of longer but less intense sessions (moderate intense intervals). Both exercises have been shown to increase fitness levels and also prevent future risk of heart disease.
The purpose of this study is to determine the efficacy and safety of high intensity interval exercise training (HIIT) in patients who had a recent cardiac revascularization procedure or recovering from a heart attack, in comparison to current standard of moderate intensity exercise training in terms of their physical fitness and psychological well-being.
Detailed description
Cardiac rehabilitation is an eight week program designed to help patients regain good health through changed lifestyle after a possible heart attack, heart surgery or other heart problems. Patients will take part in exercise sessions and education lessons, tailored to meet their personal needs. The exercise training component of cardiac rehabilitation may be delivered as intervals of short intense sessions (also known as high intensity intervals) or the current standard care of longer but less intense sessions (moderate intense intervals). Both exercises have been shown to increase fitness levels and also prevent future risk of heart disease. Although there is some evidence to suggest that high intensity interval training produces better body muscles recovery and fitness during cardiac rehabilitation, many important health outcomes have not yet been determined. Such outcomes include the ability of the body to safely control blood pressure and heartbeat rate. Others include health-related quality of life and emotional well-being.
This study will explore whether there are any differences in health outcomes before and after the introduction of the intervention for patients undergoing high intensity interval exercise compared to those on moderate intensity interval exercise in terms of the recovery of the ability to control blood pressure and heartbeat rate, and also health-related quality of life and emotional well-being. In addition, patients' opinions will be sought regarding pain levels, the acceptability and the extent of enjoyment they get from each of the two types of exercise training.
For each patient, their exercise program will be designed to match their preferences and requirements. Some may prefer to work in a gym environment and so will have their program designed around this type of activity. Others may prefer to work in a group exercise circuit, with their program matched to what is available. When comparing the two types of exercise, everything will be kept the same; from the warm up and cool down, to the types of movements; the only thing that will change is the intensity of the exercise.
Before and after the eight week training program, patients will be asked to have an assessment to measure the effects that the exercise has on their body. Things like heart rate and blood pressure will be taken and they will also undergo a physical fitness test.
After the training, patients will complete questionnaires to establish their level of enjoyment of the program, how motivated they were to complete it. In addition, their quality of life and emotional well-being will be measured by completing questionnaires before and after the 8 weeks of the cardiac rehabilitation program. The investigators anticipate that a total of 46 patients will be recruited for the study over a period of 6 months. In the United Kingdom, it is believed that delivering an improved exercise training program has the potential to enhance patients' recovery from heart disease that may reduce the need for hospital services and therefore a better use of the National Health Service resources.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training (HIIT) | Experimental | Other: High intensity interval training (HIIT)Patients will undergo a 15-minute warm-up, followed by a 24-minute conditioning phase, and a 10-minute cool-down. The conditioning phase will include a combination of aerobic exercise (e.g. cycling or walking) and resistance exercise (e.g. squats, bicep curls). Patients will complete 5 intervals of 3 minutes with 2 minute rest periods interspersed. The intensity will correspond to 16-17 on the Borg 6-20 Rating of perceived exertion scale. Patients will exercise once a week for 8 weeks. |
| Standard Care | Active comparator | Other: Standard carePatients assigned to this group will participate in usual standard care of cardiac rehabilitation. Commonly, patients will undergo a 15-minute warm-up, followed by a 24-minute conditioning phase, and a 10-minute cool-down. The conditioning phase will include a combination of aerobic exercise (e.g. cycling or walking) and resistance exercise (e.g. squats, bicep curls). Patients will complete 5 intervals of 3 minutes with 2 minute rest periods interspersed. The intensity will correspond to 11-15 on the Borg 6-20 Rating of perceived exertion scale. Patients will exercise once a week for 8 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- History of acute coronary syndromes, had a recent revascularization procedure
- History of stable heart failure or stable angina.
Key exclusion criteria (11 listed)
- Unstable angina
- Systolic blood pressure of >200 mm Hg, or diastolic blood pressure >110 mm Hg (should be assessed on a case-by-case basis)
- Orthostatic blood pressure drop of >20 mm Hg with symptoms
- May have had the implantation of cardiac defibrillators (ICD)
- Synchronization devices or ventricular assist devices
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 |
|---|---|---|
| High intensity interval training (HIIT)Also: Group 1Standard care cardiac rehabilitation classes, delivered at a higher exercise intensity | Other | High intensity interval training (HIIT) |
| Standard careAlso: Group 2Standard care cardiac rehabilitation according to current guidelines | Other | Standard Care |
Primary outcome
Changes in Heart Rate Variability (as measured by a hemodynamic monitoring system)
Time frame: Change from baseline in heart rate variability at 8 weeks after the start of the intervention
The primary outcome is the difference in heart rate variability between baseline and 8 weeks after the start of the intervention measured using finger photoplethysmography
5 secondary outcomes
Changes in Baroreflex Sensitivity (as measured by a hemodynamic monitoring system)
Time frame: Change from baseline in baroreflex sensitivity at 8 weeks after the start of the intervention
Changes in Peak Oxygen Uptake (as measured by a submaximal exercise test)
Time frame: Changes in peak oxygen uptake between baseline and 8 weeks after the start of intervention
Changes in Enjoyment of Exercise (as measured by a questionnaire)
Time frame: Changes in perception of enjoyment of exercise at between baseline and 8 weeks after the start of intervention
Changes in health-related Quality of Life (as measured by a questionnaire)
Time frame: Changes in health-related quality of life between baseline and 8 weeks after the start of intervention
Changes in Rating of Perceived Exertion (as measured by a scale)
Time frame: Changes in the rating of perceived exertion between baseline and 8 weeks after start of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Results publication: PubMed 19962772Munk PS, Butt N, Larsen AI. High-intensity interval exercise training improves heart rate variability in patients following percutaneous coronary intervention for angina pectoris. Int J Cardiol. 2010 Nov 19;145(2):312-314. doi: 10.1016/j.ijcard.2009.11.015. Epub 2009 Dec 5.
- Results publication: PubMed 22694349Guiraud T, Nigam A, Gremeaux V, Meyer P, Juneau M, Bosquet L. High-intensity interval training in cardiac rehabilitation. Sports Med. 2012 Jul 1;42(7):587-605. doi: 10.2165/11631910-000000000-00000.
- Results publication: PubMed 11581152Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available.
- Results publication: PubMed 23724882Currie KD, Rosen LM, Millar PJ, McKelvie RS, MacDonald MJ. Heart rate recovery and heart rate variability are unchanged in patients with coronary artery disease following 12 weeks of high-intensity interval and moderate-intensity endurance exercise training. Appl Physiol Nutr Metab. 2013 Jun;38(6):644-50. doi: 10.1139/apnm-2012-0354. Epub 2013 Jan 17.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Alison C Welsh principal investigator
Edge Hill University and Liverpool Heart and Chest Hospital
Adrian Roose principal investigator
Liverpool Heart and Chest Hospital
Joseph Mills principal investigator
Liverpool Heart and Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training (HIIT) in people with Heart Disease and Heart Attacks, run by Liverpool Heart and Chest Hospital NHS Foundation Trust 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 18 Aug 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Heart Rate Variability (as measured by a hemodynamic monitoring system) (time frame: Change from baseline in heart rate variability at 8 weeks after the start of the intervention). 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 NCT02376244, which also lists 4 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 18 Aug 2016.