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

NCT02376244 | Completed

• 1 other identifier: SP 006 - HIIT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Heart Disease; Heart Attacks

Keywords

High intensity Interval Exercise training; Cardiac rehabilitation; cardiac revascularisation; Percutaneous coronary interventions; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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)

  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 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

• Changes in Rating of Perceived Exertion (as measured by a scale)

  Changes in the rating of perceived exertion between baseline and 8 weeks after start of intervention

Other Outcomes (1)

• Changes in reported incidents of acute pain (as measured by a visual analogue scale)

  Changes between baseline incidents of acute pain and 8 weeks after start of intervention

Study Arms (2)

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.

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.

Other: Standard care

Interventions

High intensity interval training (HIIT) OTHER

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

Also known as: Group 1

High intensity interval training (HIIT)

Standard care OTHER

Standard care cardiac rehabilitation according to current guidelines

Also known as: Group 2

Standard Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• Edge Hill University: collaborator

Study Sites (1)

Liverpool Heart and Chest Hospital

Liverpool, L14 3PE, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 19962772 RESULT

• 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.

  PMID: 22694349 RESULT

• 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.

  PMID: 11581152 RESULT

• 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.

  PMID: 23724882 RESULT

MeSH Terms

Conditions

Heart Diseases; Myocardial Infarction

Interventions

High-Intensity Interval Training; Standard of Care

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alison C Welsh

  Edge Hill University and Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

• Adrian Roose

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

• Joseph Mills

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

• Bashir Matata

  Liverpool Heart and Chest Hospital

  PRINCIPAL INVESTIGATOR

• Adrian Midgley

  Edge Hill University

  PRINCIPAL INVESTIGATOR

• Felipe Cunha

  Edge Hill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2015
• First Posted: March 3, 2015
• Study Start: September 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 18, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)