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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
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:
The present study will analyze and compare the chronic effects of two different protocols of aerobic exercise in subjects with heart failure on telomere length.

Condition or disease Intervention/treatment Phase
Heart Failure Other: HIIT and MCT Other: MCT Other: Control Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: MCT
Composite of the execution of moderated continuos exercise (MCE)
Other: MCT
Moderated exercise

Experimental: Control
Consisting of one session per week of different activities, such as educational lectures in health and wellness.
Other: Control
Weekly lectures and educational approach




Primary Outcome Measures :
  1. Biological Aging [ Time Frame: 12 weeks ]
    Telomere Length


Secondary Outcome Measures :
  1. Aerobic Capacity [ Time Frame: 12 weeks ]
    Cardiopulmonary Exercise Test - VO2peak

  2. Body Composition [ Time Frame: 12 weeks ]
    Bioimpedance

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ejection fraction < 40% - determinated by doppler echocardiography;
  • NYHA fucntional class between II and III;
  • Individuals able to perform the protocol of physical exercise.

Exclusion Criteria:

  • Severe pulmonary disease;
  • Moderate to severe valve disease;
  • Peripheral arterial disease with intermittent claudication;
  • Stable angina
  • Uncontrolled diabetes
  • Uncontrolled hypertension (systolic pressure greater than 180 mmHg and diastolic pressure greater than 100 mmHg)
  • Haemodialysis;
  • Atrial fibrillation;
  • Complex arrhythmia and ischemia that compromise cardiac function;
  • Presence of pacemaker
  • Cognitive condition and / or osteomyelitis that prevents the performance of any stage of the experiment of 150 minutes or more of moderate physical activity per week;
  • Current participation, or less than three months in another clinical trial and unable to attend HCPA three times a week.

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): NCT03856736


Contacts
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Contact: Leandro T Franzoni 555133597634 lfranzoni@hcpa.edu.br

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035903
Contact: Leandro T Franzoni    5133597634    lfranzoni@hcpa.edu.br   
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Ricardo Stein, PhD Hospital de Clínicas de Porto Alegre

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT03856736     History of Changes
Other Study ID Numbers: 180651
First Posted: February 27, 2019    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Hospital de Clinicas de Porto Alegre:
Heart Failure
Telomere Length
Aerobic Exercise
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases