Aerobic Exercise and Telomere Length in Patients With Heart Failure.
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|ClinicalTrials.gov Identifier: NCT03856736|
Recruitment Status : Recruiting
First Posted : February 27, 2019
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: HIIT and MCT Other: MCT Other: Control||Not Applicable|
Aging can be characterized by an organic and functional decrease, which is not related to disease, that is, a process that happens naturally over time. One of the markers of the aging process is telomeres, which consist of a complex of DNA sequences located at the ends of the chromosome, composed of protective proteins that have the function of protecting information from the DNA (genome), that is, telomeres are responsible for reconstructing the information lost during cell division due to the wear and tear of the chromosome ends. The telomere length may be shorter in some diseases, such as heart failure with reduced ejection fraction (HFREF) compared with healthy subjects.
The HFREF is a complex clinical syndrome of poor prognosis and high prevalence. Its characteristics include fatigue, dyspnea and intolerance to physical exertion due to reduction in cardiac output, concomitant with respiratory changes, weakness in peripheral muscles and incidence of depression. Exercise as a strategy for the treatment of heart failure (HF) can be effective in improving the quality of life, functional capacity and prognosis of the disease. In sedentary individuals who do not have HF, a natural reduction of telomeres occurs, which is associated with the early development of the aging process. Increasing or maintaining the size of telomeres can be a way to intervene in the aging process and thus slow the progression of HF, since one of its main functions is to protect the chromosome from cellular aging.
One of the most promising strategies for intervening in aging is the practice of physical exercise. However, the effects of physical exercise on the telomere length of individuals with HF are unknown. However, we know that physical exercise for HF shows positive results in relation to functional capacity, as measured by peak oxygen consumption (VO2peak). In addition, the improvement in functional capacity, increase in peak oxygen consumption (VO2peak), is directly related to the increase in telomere length. However, there is a lack of concise results in the literature regarding the chronic effects of aerobic exercise on the telomere length in subjects with HF.
Therefore, the aim of the present study will be to analyze and compare the chronic effects of two different protocols of aerobic exercise in subjects with HF on telomere length.
The specifics aims of this study are: to analyze and compare the chronic effects of two different protocols of physical exercise in individuals with HF in the following variables: Functional Capacity (Cardiopulmonary Exercise Testing); Body Composition (Bioimpedance); Quality of Life (Minnesota Questionnaire).
This is a randomized clinical trial, with three intervention groups that will be assessed pre and post intervention. The randomization sequence will be generated by REDCap and it will be performed by a participant not involved in the other study phases (principal investigators will be blinded).
For significance level of 5%, power of 80%, difference to be detected equal to the standard deviation of 0.0026, the sample size calculated is 12 patients for each group (36 in total). Considering 20% loss, it will be necessary to include 15 patients per group (45 patients in total).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Effects of Two Different Aerobic Training on Telomere Length in Patients With Heart Failure: Randomized Clinical Trial.|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||November 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Experimental: HIIT and MCT
High Intensity Interval Training (HIIT) and Moderated Continuous Training (MCT), composite by the execution of moderated continuous exercises and high intensity interval exercises in the first two mesocycles, in the last mesocycle will only perform the HIIE.
Other: HIIT and MCT
High Intensity and Moderated Exercise
Composite of the execution of moderated continuos exercise (MCE)
Consisting of one session per week of different activities, such as educational lectures in health and wellness.
Weekly lectures and educational approach
- Biological Aging [ Time Frame: 12 weeks ]Telomere Length
- Aerobic Capacity [ Time Frame: 12 weeks ]Cardiopulmonary Exercise Test - VO2peak
- Body Composition [ Time Frame: 12 weeks ]Bioimpedance
- Health-Related Quality of Life: MLHFQ [ Time Frame: 12 weeks ]Health-Related Quality of Life will be measured by a questionnaire (Minnesota Living with Heart Failure questionnaire - MLHFQ)
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): NCT03856736
|Contact: Leandro T Franzonifirstname.lastname@example.org|
|Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035903|
|Contact: Leandro T Franzoni 5133597634 email@example.com|
|Principal Investigator:||Ricardo Stein, PhD||Hospital de Clínicas de Porto Alegre|