The Effect Of An Expanded Long Term Periodization Exercise Training In Patients With Cardiovascular Disease

NCT03335319 | Completed DMC

• 1 other identifier: 30/2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Benefits from cardiac rehabilitation (CR) programs are evidence based and widely recognized. Less than 50% of people who participate in hospital-based CR programs maintain an exercise regimen for as long as six months after completion. Despite the benefits associated with regular exercise training (ET), adherence with supervised exercise-based CR remains low. Current exercise guidelines for CR focus on moderate intensity steady state exercises, with walking and cycling being the most recommended types of ET. The repetitive nature of this type of activity can become monotonous for the patient, affecting exercise adherence, compliance and training outcomes. Exercise periodization is a method typically used in sports training, but the impact of periodized exercise to yield optimal beneficial effects in cardiac patients is still unclear. In healthy or trained populations, periodization aims to optimize ET adaptations as compared with non periodized training, to prevent overtraining and to avoid plateauing of training adaptations. Periodized methods are considered to be superior to non periodized methods in trained populations and appears to be superior in inactive adults. In most of the CR programs there are no periodization or exercise progression during medium to long term interventions. Further randomized controlled trials (RCT) are necessary to evaluate long-term periodization outcomes. The purpose of this research project is twofold:

1. 1.To conduct a 12-month randomized control trial to evaluate the effects of a periodized ET regime versus a non periodized ET regime (guidelines) on VO2 peak, maximal strength, body composition, functionality and quality of life in cardiovascular disease patients.
2. 2.to differentiate the effects of a 12-month periodized ET regime versus a non periodized ET regime on the different components of the oxygen kinetics response and oxidative adaptations in cardiovascular disease patients.

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Keywords

Cardiovascular Disease; Coronary Artery Disease; Cardiopulmonary Exercise Testing; Oxygen Uptake Kinetics; Skeletal Muscle Oxygenation; Exercise Training; Periodized Exercise

Outcome Measures

Primary Outcomes (2)

• Change of peak oxygen consumption during cardiopulmonary exercise testing

  A symptom-limited ramp incremental cardiopulmonary exercise test, will be performed on a cycle ergometer (Ergostik, Geratherm Respiratory GmbH, Germany) with breath-by-breath gas exchange measurements. Each patient will be encouraged to exercise to exhaustion (20 Watt+20 Watt/min or 15 Watt+15 Watt/min or 10 Watt+10 Watt/min), as defined by intolerance, leg fatigue or dyspnea unless clinical criteria for test termination occurred. Peak oxygen capacity will be considered the highest attained VO2 during the final 30s of exercise. All patients should achieve a respiratory exchange ratio of \>1.1, an indicator of maximal effort.

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

• Change of oxygen kinetics during submaximal test

  The test load is set at 80% of the value of the work rate corresponding to the Anaerobic Threshold detected in the maximum test, which was performed first, or 50% of VO2 peak, if the Anaerobic Threshold could not be adequately determined. Cardiopulmonary data will be recorded for 5 minutes at rest followed by 1 minute unloaded pedaling. After unloaded pedaling, patients will perform the constant load test for 6 min at the work rate described above, followed by unloaded pedaling for 5min. To improve the confidence of the kinetic parameter determination, this test will be performed three times and the averaged profile will be used for the kinetic analysis.

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

Secondary Outcomes (16)

• Change of Anaerobic Threshold VO2 during cardiopulmonary exercise testing

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

• Change of Anaerobic Threshold Heart Rate during cardiopulmonary exercise testing

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

• Change of Anaerobic Threshold Watts during cardiopulmonary exercise testing

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

• Change of Respiratory Compensation Point VO2 during cardiopulmonary exercise testing

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

• Change of Respiratory Compensation Point Heart Rate during cardiopulmonary exercise testing

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

Other Outcomes (5)

• Change of six minute walking test distance

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

• Change of 30-second chair stand repetitions

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

• Change of 8-foot up and go test duration

  At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET

Study Arms (2)

Periodized Exercise Training Regime

EXPERIMENTAL

The ET program will be carried out 3 times a week (60 minutes per session) on non-consecutive days for 48 weeks and supervised for both groups. Exercise prescription will be gradually progressed through various combinations of duration, frequency and/or intensity of training. Over the 1st-15th exercise sessions: MCT and anatomical resistance training; from the 16th-30th session: combined ET with HIIT and hypertrophy; from the 31st-45th exercise session, after the adjustments of the respectively time point assessments: MCT and maximal strength; from the 46th-60th exercise sessions: HIIT with hypertrophy; at the end of the 60th session until the end (6 months has passed): the same exercise prescription will repeat all over again at the same order.

Other: Periodized Exercise Training Regime

Non Periodized Exercise Training Regime

ACTIVE COMPARATOR

participants will do a combined ET regime (aerobic and RT). Aerobic component: combine moderate to vigorous exercises 3 d.wk-1 on nonconsecutive days, for 20 min per session, involving major muscle groups using the available ergometers to perform continuous and rhythmic activities in nature. Resistance component: RT should be performed after the aerobic component of the exercise session to allow for adequate warm-up. Initial load should be trained initially with one set of 10-15 repetitions that can be lifted without straining (\~30%-40% 1RM for the upper body; \~50%-60% 1 RM for the lower body). Each major muscle group should be trained initially with one set; multiple set regimens may be introduced later as tolerated. It will be performed 8-10 exercises of the major muscle groups.

Other: Non Periodized Exercise Training Regime

Interventions

Periodized Exercise Training Regime OTHER

MCT 1st: 20 min on an ergometer; at Anaerobic Threshold (AT) 1 or, if the AT could not be adequately determined, 50-60% of the Heart Rate Reserve (HRR), Borg Rating of Perceived Exertion (RPE) equivalent 9-11. MCT 2nd: 20 minutes; 60-70%HRR, RPE 12-13. HIIT 1st: 4 interval training periods of 2 minutes (AT2 intensity or 80-90%HRR, RPE 15-17) and 4 active pauses of 2 minutes (below AT 1 or 40-50%HRR, RPE 6-9) between interval training periods. HIIT 2nd: same intervals as in 1st HIIT different intensities: high intensity interval above AT2 intensity or \> 90%HRR, RPE 17-19 and active pauses at AT 1 or 50-60%HRR, RPE 9-11. Resistance training adaptation: 2 sets of 15-20 repetitions 50% 1RM; Hypertrophy: 2 sets 8-12 repetitions at 60% 1RM; Maximal Strength: 2 sets of 6-8 repetitions at 80% 1RM.

Periodized Exercise Training Regime

Non Periodized Exercise Training Regime OTHER

To ensure that total training loads were similar in both groups despite differences in intensity, it will be used the training impulses (TRIMP) method from Edwards for the aerobic component and the volume load method for the RT component. All sessions will include 10 minutes of warm up and cool down standardized for both groups. By design, the non periodized group involves an identical total training volume and time commitment but differed regarding metabolic stress induced by the linear periodized group. All patients will be monitored with a HR monitor during the execution of the exercise session in order to achieve the HR training. Blood pressure will be assessed before and after completing each session. If necessary, the blood pressure will be measured during the ET session.

Non Periodized Exercise Training Regime

Eligibility Criteria

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

You may qualify if:

• angiographically documented coronary artery disease in at least one major epicardial vessel
• myocardial infarction,
• coronary revascularization (coronary artery bypass grafting, percutaneous transluminal coronary angioplasty, or coronary artery stent),

You may not qualify if:

• heart failure
• unstable angina pectoris
• heart transplants with either cardiac resynchronization therapy or implantable defibrillators
• inability to comply with guidelines for participation in exercise testing and training
• significant limiting and/or unstable comorbidities that would prevent full participation

Sponsors & Collaborators

• University of Lisbon: lead

Study Sites (1)

Faculty of Human Kinetics - University of Lisbon

Lisbon, Cruz Quebrada, 1495-687, Portugal

Location

Related Publications (14)

• Humphrey R, Guazzi M, Niebauer J. Cardiac rehabilitation in Europe. Prog Cardiovasc Dis. 2014 Mar-Apr;56(5):551-6. doi: 10.1016/j.pcad.2013.08.004. Epub 2013 Oct 5.

  PMID: 24607021 BACKGROUND

• Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.

  PMID: 27222591 BACKGROUND

• Elliott AD, Rajopadhyaya K, Bentley DJ, Beltrame JF, Aromataris EC. Interval training versus continuous exercise in patients with coronary artery disease: a meta-analysis. Heart Lung Circ. 2015 Feb;24(2):149-57. doi: 10.1016/j.hlc.2014.09.001. Epub 2014 Sep 16.

  PMID: 25306500 BACKGROUND

• Liou K, Ho S, Fildes J, Ooi SY. High Intensity Interval versus Moderate Intensity Continuous Training in Patients with Coronary Artery Disease: A Meta-analysis of Physiological and Clinical Parameters. Heart Lung Circ. 2016 Feb;25(2):166-74. doi: 10.1016/j.hlc.2015.06.828. Epub 2015 Jul 22.

  PMID: 26375499 BACKGROUND

• Marzolini S, Oh PI, Brooks D. Effect of combined aerobic and resistance training versus aerobic training alone in individuals with coronary artery disease: a meta-analysis. Eur J Prev Cardiol. 2012 Feb;19(1):81-94. doi: 10.1177/1741826710393197. Epub 2011 Feb 21.

  PMID: 21450617 BACKGROUND

• Anderson L, Oldridge N, Thompson DR, Zwisler AD, Rees K, Martin N, Taylor RS. Exercise-Based Cardiac Rehabilitation for Coronary Heart Disease: Cochrane Systematic Review and Meta-Analysis. J Am Coll Cardiol. 2016 Jan 5;67(1):1-12. doi: 10.1016/j.jacc.2015.10.044.

  PMID: 26764059 BACKGROUND

• Madssen E, Arbo I, Granoien I, Walderhaug L, Moholdt T. Peak oxygen uptake after cardiac rehabilitation: a randomized controlled trial of a 12-month maintenance program versus usual care. PLoS One. 2014 Sep 23;9(9):e107924. doi: 10.1371/journal.pone.0107924. eCollection 2014.

  PMID: 25247991 BACKGROUND

• Rhea MR, Alderman BL. A meta-analysis of periodized versus nonperiodized strength and power training programs. Res Q Exerc Sport. 2004 Dec;75(4):413-22. doi: 10.1080/02701367.2004.10609174.

  PMID: 15673040 BACKGROUND

• Strohacker K, Fazzino D, Breslin WL, Xu X. The use of periodization in exercise prescriptions for inactive adults: A systematic review. Prev Med Rep. 2015 May 6;2:385-96. doi: 10.1016/j.pmedr.2015.04.023. eCollection 2015.

  PMID: 26844095 BACKGROUND

• Conlon JA, Newton RU, Tufano JJ, Banyard HG, Hopper AJ, Ridge AJ, Haff GG. Periodization Strategies in Older Adults: Impact on Physical Function and Health. Med Sci Sports Exerc. 2016 Dec;48(12):2426-2436. doi: 10.1249/MSS.0000000000001053.

  PMID: 27434088 BACKGROUND

• Balady GJ, Arena R, Sietsema K, Myers J, Coke L, Fletcher GF, Forman D, Franklin B, Guazzi M, Gulati M, Keteyian SJ, Lavie CJ, Macko R, Mancini D, Milani RV; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Interdisciplinary Council on Quality of Care and Outcomes Research. Clinician's Guide to cardiopulmonary exercise testing in adults: a scientific statement from the American Heart Association. Circulation. 2010 Jul 13;122(2):191-225. doi: 10.1161/CIR.0b013e3181e52e69. Epub 2010 Jun 28. No abstract available.

  PMID: 20585013 BACKGROUND

• Yamamoto S, Hotta K, Ota E, Mori R, Matsunaga A. Effects of resistance training on muscle strength, exercise capacity, and mobility in middle-aged and elderly patients with coronary artery disease: A meta-analysis. J Cardiol. 2016 Aug;68(2):125-34. doi: 10.1016/j.jjcc.2015.09.005. Epub 2015 Dec 12.

  PMID: 26690738 BACKGROUND

• Shepherd CW, While AE. Cardiac rehabilitation and quality of life: a systematic review. Int J Nurs Stud. 2012 Jun;49(6):755-71. doi: 10.1016/j.ijnurstu.2011.11.019. Epub 2011 Dec 23.

  PMID: 22197653 BACKGROUND

• Pinto R, Angarten V, Santos V, Melo X, Santa-Clara H. The effect of an expanded long-term periodization exercise training on physical fitness in patients with coronary artery disease: study protocol for a randomized controlled trial. Trials. 2019 Apr 11;20(1):208. doi: 10.1186/s13063-019-3292-9.

  PMID: 30975195 DERIVED

Related Links

• Official Website of the Cardiovascular Rehabilitation Center of the University of Lisbon (CRECUL)

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Helena Santa-Clara, PhD

  Faculty of Human Kinetics, University of Lisbon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be randomized and stratified (by gender and age) into either one of the two groups exercise training groups: 1) periodization or 2) non periodization. The randomization code will be developed with a computer random-number generator to select random permuted blocks.

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: November 7, 2017
• Study Start: October 1, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.

Locations

PT (1)