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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335319
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Maria Helena Santa-Clara Pombo Rodrigues, University of Lisbon

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. 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. 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.

These patients will be randomized in 2 ET groups: 1) periodization; 2) non periodization. This experimental design will occur during 48 weeks 3 times per week with 4 assessment time points: M0) before starting the ET program (baseline); M1) 3 months after starting the ET; M2) 6 months after starting the ET program and M3) 12 months at the end of the community-based ET program.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Coronary Artery Disease Other: Periodized Exercise Training Regime Other: Non Periodized Exercise Training Regime Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect Of An Expanded Long Term Periodization Exercise Training In Patients With Cardiovascular Disease: Central And Peripheral Adaptations
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Periodized Exercise Training Regime
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
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.

Active Comparator: Non Periodized Exercise Training Regime
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
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.




Primary Outcome Measures :
  1. Change of peak oxygen consumption during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    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.

  2. Change of oxygen kinetics during submaximal test [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    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.


Secondary Outcome Measures :
  1. Change of Anaerobic Threshold VO2 during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Change in VO2 reached at the maximal cardiopulmonary exercise test at the Anaerobic Threshold.

  2. Change of Anaerobic Threshold Heart Rate during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Change in heart rate reached at the maximal cardiopulmonary exercise test at the Anaerobic Threshold.

  3. Change of Anaerobic Threshold Watts during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Change in watts reached at the maximal cardiopulmonary exercise test at the Anaerobic Threshold.

  4. Change of Respiratory Compensation Point VO2 during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Change in VO2 reached at the maximal cardiopulmonary exercise test at the Respiratory Compensation Point.

  5. Change of Respiratory Compensation Point Heart Rate during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Change in heart rate reached at the maximal cardiopulmonary exercise test at the Respiratory Compensation Point.

  6. Change of Respiratory Compensation Point Watts during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Change in watts reached at the maximal cardiopulmonary exercise test at the Respiratory Compensation Point.

  7. Change of Peak Heart Rate reached during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Maximal heart rate reached at the cardiopulmonary exercise testing.

  8. Change of Maximal Watts reached during cardiopulmonary exercise testing [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Maximal watts reached at the cardiopulmonary exercise testing.

  9. Change of Deoxyhaemoglobin of the vastus lateralis muscle at the submaximal test [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    The muscle deoxygenation dynamics of the Vastus Lateralis muscle will be evaluated throughout the submaximal CPET. Deoxyhaemoglobin (HHb) concentration will be quantified with a continuous-wave tissue oximeter (NIMO, Nirox srl, Brescia, Italy), based on the Near-infrared Spectroscopy (NIRS) system, which provides continuous, non-invasive monitoring of the relative concentration changes in these variables during rest and exercise.

  10. Change of Oxyhaemoglobin of the vastus lateralis muscle at the submaximal test [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    The muscle deoxygenation dynamics of the Vastus Lateralis muscle will be evaluated throughout the submaximal CPET. Oxyhaemoglobin (HbO2) concentration will be quantified with a continuous-wave tissue oximeter (NIMO, Nirox srl, Brescia, Italy), based on the Near-infrared Spectroscopy (NIRS) system, which provides continuous, non-invasive monitoring of the relative concentration changes in these variables during rest and exercise.

  11. Change of Total Haemoglobin of the vastus lateralis muscle at the submaximal test [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    The muscle deoxygenation dynamics of the Vastus Lateralis muscle will be evaluated throughout the submaximal CPET. Total haemoglobin (HbT) concentration will be quantified with a continuous-wave tissue oximeter (NIMO, Nirox srl, Brescia, Italy), based on the Near-infrared Spectroscopy (NIRS) system, which provides continuous, non-invasive monitoring of the relative concentration changes in these variables during rest and exercise.

  12. Change of Maximal Strength [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Maximal strength will be assessed by 1 Repetition Maximum (1RM) test for each of six weight exercises on variable resistance machines as follows: leg press, leg extension, leg curl, low row, chest press and lat pull down. The protocol will include four pre-test sessions to familiarize each patient with the test procedures. Correct exercise and breathing techniques (avoidance of the Valsalva manoeuvre) will be practiced.

  13. Change of Lean Soft-Tissue [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Total and regional lean soft-tissue will be estimated using dual energy radiographic absorptiometry (DXA) (Hologic Explorer-W, fan-beam densitometer, software QDR for windows version 12.4, Hologic, USA).

  14. Change of Fat Mass [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Total and regional body mass fat mass will be estimated using dual energy radiographic absorptiometry (DXA) (Hologic Explorer-W, fan-beam densitometer, software QDR for windows version 12.4, Hologic, USA).

  15. Change of Bone Mineral Content [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    Total bone mineral content will be estimated using dual energy radiographic absorptiometry (DXA) (Hologic Explorer-W, fan-beam densitometer, software QDR for windows version 12.4, Hologic, USA).

  16. Change of Quality of Life [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    The Short Form-36 Health Survey (SF-36) is a self-assessment health status questionnaire composed of 36 questions about socio-demographic, health and personal behavior. A Portuguese validated version of SF-36 is available.


Other Outcome Measures:
  1. Change of six minute walking test distance [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    The six minute walking test (6MWT) will be performed indoors, along a long flat, straight, enclosed 20-meter corridor with a hard surface that is seldom. Total distance during the test will be recorded.

  2. Change of 30-second chair stand repetitions [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    The 30-second chair stand, assesses the lower body strength, needed for numerous tasks such as climbing stairs or walking.

  3. Change of 8-foot up and go test duration [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    The 8-foot (2.44 meters) up and go test evaluates the agility/dynamic balance, which is important in tasks that require quick maneuvering.

  4. Change of chair sit-and-reach distance reached [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    For the flexibility for the lower limbs it will be assessed the chair sit-and-reach.

  5. Change of back scratch test distance reached [ Time Frame: At baseline, 3 months after starting the ET, 6 months after starting the ET and 12 months after starting the ET ]
    For the flexibility for the upper limbs it will be assessed the back scratch test.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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),

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335319


Locations
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Portugal
Faculty of Human Kinetics - University of Lisbon
Lisbon, Cruz Quebrada, Portugal, 1495-687
Sponsors and Collaborators
University of Lisbon
Investigators
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Principal Investigator: Helena Santa-Clara, PhD Faculty of Human Kinetics, University of Lisbon
  Study Documents (Full-Text)

Documents provided by Maria Helena Santa-Clara Pombo Rodrigues, University of Lisbon:
Additional Information:
Publications:
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corrà U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Løchen ML, Löllgen 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Helena Santa-Clara Pombo Rodrigues, Assistant Professor, University of Lisbon
ClinicalTrials.gov Identifier: NCT03335319    
Other Study ID Numbers: 30/2017
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participant data for all primary and secondary outcome measures will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Helena Santa-Clara Pombo Rodrigues, University of Lisbon:
Cardiovascular Disease
Coronary Artery Disease
Cardiopulmonary Exercise Testing
Oxygen Uptake Kinetics
Skeletal Muscle Oxygenation
Exercise Training
Periodized Exercise
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases