The Health Impact of High Intensity Exercise Training With Intervals During Cardiac Rehabilitation

NCT ID: NCT02376244

Last Updated: 2016-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Disease Heart Attacks

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

High intensity interval training (HIIT)

Intervention Type OTHER

Standard care cardiac rehabilitation classes, delivered at a higher exercise intensity

Standard Care

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.

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

Standard care cardiac rehabilitation according to current guidelines

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High intensity interval training (HIIT)

Standard care cardiac rehabilitation classes, delivered at a higher exercise intensity

Intervention Type OTHER

Standard care

Standard care cardiac rehabilitation according to current guidelines

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Group 1 Group 2

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* History of acute coronary syndromes, had a recent revascularization procedure
* History of stable heart failure or stable angina.

Exclusion Criteria

* 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, -
* 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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Edge Hill University

OTHER

Sponsor Role collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alison C Welsh

Role: PRINCIPAL_INVESTIGATOR

Edge Hill University and Liverpool Heart and Chest Hospital

Adrian Roose

Role: PRINCIPAL_INVESTIGATOR

Liverpool Heart and Chest Hospital

Joseph Mills

Role: PRINCIPAL_INVESTIGATOR

Liverpool Heart and Chest Hospital

Bashir Matata

Role: PRINCIPAL_INVESTIGATOR

Liverpool Heart and Chest Hospital

Adrian Midgley

Role: PRINCIPAL_INVESTIGATOR

Edge Hill University

Felipe Cunha

Role: PRINCIPAL_INVESTIGATOR

Edge Hill University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 19962772 (View on PubMed)

Guiraud 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.

Reference Type RESULT
PMID: 22694349 (View on PubMed)

Fletcher 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.

Reference Type RESULT
PMID: 11581152 (View on PubMed)

Currie 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.

Reference Type RESULT
PMID: 23724882 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SP 006 - HIIT

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Acute Effects of HIIT vs. MICT on HRV
NCT06437145 RECRUITING NA