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The study aims to investigate if physical capacity obtained in the cardiopulmonary exercise test can predict cardiovascular alterations in Hodgkin Lymphoma (HL) Survivors. In addition, to study the effects of exercise training on physical capacity and cardiovascular responses in these patients.
Hodgkin Lymphoma (HL) is a hematological neoplasia that mainly affects young people. Anthracycline-based chemotherapy, followed or not by mediastinal radiotherapy, substantially improves prognosis in this set of patients. Observational studies have shown that cardiovascular disease is the most non oncologic cause of death in this population. Coronary artery disease (CAD) affects 26% of survivors after 10 years of absence of HL . However, the early intervention and the assessment to predict the cardiovascular risk remain little known. In this study, the investigators will test the hypothesis that physical capacity can predict the cardiovascular alterations in HL Survivors. In addition, exercise training improves physical capacity and heart rate responses in this set of patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise training group | Experimental | Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks |
|
| Control Group | Sham Comparator | Patients will be only clinically followed up. They will not perform exercise training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Characteristics | Procedure | Body Weight, Height |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical Capacity - Peak oxygen consumption (mL/kg/min) | Oxygen consuption in crescent effort will be calculated by aggregation of volume (mL), body weight (Kg) and time (minutes). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Hate (beat/min) | Post-exercise heart rate will be evaluated by the number of beats in time masurement (one minute). | 4 months |
| Cardiac Function - Ejection Fraction | Ejection Fraction (EF=ESV-EDV/EDV) combines end systolic (ESV) and diastolic volumes (EDV)(mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos E Negrao, PhD | Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luciana de Souza Santos | São Paulo | São Paulo | 05403-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26541251 | Background | Ansell SM. Hodgkin Lymphoma: Diagnosis and Treatment. Mayo Clin Proc. 2015 Nov;90(11):1574-83. doi: 10.1016/j.mayocp.2015.07.005. | |
| 17194904 | Background | Heidenreich PA, Schnittger I, Strauss HW, Vagelos RH, Lee BK, Mariscal CS, Tate DJ, Horning SJ, Hoppe RT, Hancock SL. Screening for coronary artery disease after mediastinal irradiation for Hodgkin's disease. J Clin Oncol. 2007 Jan 1;25(1):43-9. doi: 10.1200/JCO.2006.07.0805. |
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| Assessment of Heart rate variability | Diagnostic Test | Holter 24h |
|
| Blood Pressure and Cardiac Autonomic Control | Diagnostic Test | Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap. |
|
| Evaluation of Baroreflex Control | Diagnostic Test | The magnitude and latency of the baroreflex control of the heart rate will be assessed by bivariate analysis using the autoregressive method. |
|
| Cardiac Function and Structure | Diagnostic Test | Echocardiogram |
|
| Assessment of Coronary Anatomy and Calcium Score | Diagnostic Test | Angiotomography |
|
| Blood Assessments | Diagnostic Test | Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010). |
|
| Physical Capacity | Diagnostic Test | Cardiopulmonary Exercise Test. |
|
| Physical Training | Procedure | Aerobic exercise: 48 sessions of 60 minutes: 5 minutes of warm-up, 40 minutes of exercise. Resistance exercise: 10 minutes of exercise and 5 minutes of recovery. |
|
| 4 months |
| 30955352 | Background | Gilchrist SC, Barac A, Ades PA, Alfano CM, Franklin BA, Jones LW, La Gerche A, Ligibel JA, Lopez G, Madan K, Oeffinger KC, Salamone J, Scott JM, Squires RW, Thomas RJ, Treat-Jacobson DJ, Wright JS; American Heart Association Exercise, Cardiac Rehabilitation, and Secondary Prevention Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Council on Peripheral Vascular Disease. Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. Circulation. 2019 May 21;139(21):e997-e1012. doi: 10.1161/CIR.0000000000000679. |
| 24613809 | Background | Girinsky T, M'Kacher R, Lessard N, Koscielny S, Elfassy E, Raoux F, Carde P, Santos MD, Margainaud JP, Sabatier L, Ghalibafian M, Paul JF. Prospective coronary heart disease screening in asymptomatic Hodgkin lymphoma patients using coronary computed tomography angiography: results and risk factor analysis. Int J Radiat Oncol Biol Phys. 2014 May 1;89(1):59-66. doi: 10.1016/j.ijrobp.2014.01.021. Epub 2014 Mar 7. |
| 22570290 | Background | Hoppe RT, Advani RH, Ai WZ, Ambinder RF, Aoun P, Bello CM, Bierman PJ, Blum KA, Chen R, Dabaja B, Duron Y, Forero A, Gordon LI, Hernandez-Ilizaliturri FJ, Hochberg EP, Maloney DG, Mansur D, Mauch PM, Metzger M, Moore JO, Morgan D, Moskowitz CH, Poppe M, Pro B, Winter JN, Yahalom J, Sundar H; National Comprehensive Cancer Network. Hodgkin lymphoma, version 2.2012 featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2012 May;10(5):589-97. doi: 10.6004/jnccn.2012.0061. |
| 12163425 | Background | Kavanagh T, Mertens DJ, Hamm LF, Beyene J, Kennedy J, Corey P, Shephard RJ. Prediction of long-term prognosis in 12 169 men referred for cardiac rehabilitation. Circulation. 2002 Aug 6;106(6):666-71. doi: 10.1161/01.cir.0000024413.15949.ed. |
| 17119114 | Background | Aleman BM, van den Belt-Dusebout AW, De Bruin ML, van 't Veer MB, Baaijens MH, de Boer JP, Hart AA, Klokman WJ, Kuenen MA, Ouwens GM, Bartelink H, van Leeuwen FE. Late cardiotoxicity after treatment for Hodgkin lymphoma. Blood. 2007 Mar 1;109(5):1878-86. doi: 10.1182/blood-2006-07-034405. Epub 2006 Nov 21. |
| 25257632 | Background | Koelwyn GJ, Jones LW, Moslehi J. Unravelling the causes of reduced peak oxygen consumption in patients with cancer: complex, timely, and necessary. J Am Coll Cardiol. 2014 Sep 30;64(13):1320-2. doi: 10.1016/j.jacc.2014.07.949. No abstract available. |
| 25677317 | Background | Groarke JD, Tanguturi VK, Hainer J, Klein J, Moslehi JJ, Ng A, Forman DE, Di Carli MF, Nohria A. Abnormal exercise response in long-term survivors of hodgkin lymphoma treated with thoracic irradiation: evidence of cardiac autonomic dysfunction and impact on outcomes. J Am Coll Cardiol. 2015 Feb 17;65(6):573-83. doi: 10.1016/j.jacc.2014.11.035. |
| 25911667 | Background | Wilson MG, Ellison GM, Cable NT. Basic science behind the cardiovascular benefits of exercise. Heart. 2015 May 15;101(10):758-65. doi: 10.1136/heartjnl-2014-306596. |
| 25424360 | Background | da Silva VP, de Oliveira NA, Silveira H, Mello RG, Deslandes AC. Heart rate variability indexes as a marker of chronic adaptation in athletes: a systematic review. Ann Noninvasive Electrocardiol. 2015 Mar;20(2):108-18. doi: 10.1111/anec.12237. Epub 2014 Nov 26. |
| 25257631 | Background | Cramer L, Hildebrandt B, Kung T, Wichmann K, Springer J, Doehner W, Sandek A, Valentova M, Stojakovic T, Scharnagl H, Riess H, Anker SD, von Haehling S. Cardiovascular function and predictors of exercise capacity in patients with colorectal cancer. J Am Coll Cardiol. 2014 Sep 30;64(13):1310-9. doi: 10.1016/j.jacc.2014.07.948. |
| 12104056 | Background | Pumprla J, Howorka K, Groves D, Chester M, Nolan J. Functional assessment of heart rate variability: physiological basis and practical applications. Int J Cardiol. 2002 Jul;84(1):1-14. doi: 10.1016/s0167-5273(02)00057-8. |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D064797 | Physical Conditioning, Human |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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