Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2017-10-21
2023-10-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
NONE
Study Groups
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Exercise training group
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Physical Characteristics
Body Weight, Height
Assessment of Heart rate variability
Holter 24h
Blood Pressure and Cardiac Autonomic Control
Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.
Evaluation of Baroreflex Control
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
Echocardiogram
Assessment of Coronary Anatomy and Calcium Score
Angiotomography
Blood Assessments
Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).
Physical Capacity
Cardiopulmonary Exercise Test.
Physical Training
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.
Control Group
Patients will be only clinically followed up. They will not perform exercise training.
Physical Characteristics
Body Weight, Height
Assessment of Heart rate variability
Holter 24h
Blood Pressure and Cardiac Autonomic Control
Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.
Evaluation of Baroreflex Control
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
Echocardiogram
Assessment of Coronary Anatomy and Calcium Score
Angiotomography
Blood Assessments
Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).
Physical Capacity
Cardiopulmonary Exercise Test.
Interventions
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Physical Characteristics
Body Weight, Height
Assessment of Heart rate variability
Holter 24h
Blood Pressure and Cardiac Autonomic Control
Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.
Evaluation of Baroreflex Control
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
Echocardiogram
Assessment of Coronary Anatomy and Calcium Score
Angiotomography
Blood Assessments
Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).
Physical Capacity
Cardiopulmonary Exercise Test.
Physical Training
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.
Eligibility Criteria
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Inclusion Criteria
* Over 18 years old
* Chemotherapy with anthracycline and mediastinal radiotherapy in the last 5 years or more
Exclusion Criteria
* Pregnant women,
* Iodinated contrast allergy,
* Life expectancy less than 1 year.
18 Years
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Carlos E Negrao, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
Locations
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Luciana de Souza Santos
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Ansell SM. Hodgkin Lymphoma: Diagnosis and Treatment. Mayo Clin Proc. 2015 Nov;90(11):1574-83. doi: 10.1016/j.mayocp.2015.07.005.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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432715154
Identifier Type: -
Identifier Source: org_study_id
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