Aerobic Exercise and Telomere Length in Patients With Heart Failure.

January 8, 2021 updated by: Hospital de Clinicas de Porto Alegre

Effects of Aerobic Exercise on Telomere Length in Patients With Systolic Heart Failure: A Randomized Clinical Trial.

The present study will analyze and compare the chronic effects of aerobic exercise in subjects with systolic heart failure on telomere length.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 HFREF.

Therefore, the aim of the present study will be to analyze and compare the chronic effects of aerobic exercise in subjects with HFREF on telomere length.

The specifics aims of this study are: to analyze and compare the chronic effects of aerobic exercise in individuals with HFREF in the following variables: Functional Capacity (Cardiopulmonary Exercise Testing); Echocardiographic Variables by Doppler echocardiogram; Endothelial Function measured by Flow-Mediated Dilation (FMD) of the Brachial Artery; Walking Ability measured by a Self-Selected Walking Speed Test (SSWST)

This is a randomized clinical trial, with two 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 10 patients for each group (20 in total). Considering 20% loss, it will be necessary to include 12 patients per group (24 patients in total).

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035903
        • Hospital de Clinicas de Porto Alegre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary diagnosis of HF with ejection fraction <40%;
  • Clinically stable patients with at least three months on optimal HF treatment;
  • Age between 50 and 80 years;
  • New York Heart Association (NYHA) functional class II to III;
  • No contraindications to participate in an exercise program;
  • Mentally able to understand instructions during the study.

Exclusion Criteria:

  • Severe valve disease;
  • Peripheral artery disease with symptoms of intermittent claudication;
  • Uncontrolled hypertension;
  • Drug or alcohol abuse;
  • Cognitive and/or osteomyoarticular conditions that prevent exercise;
  • Logistical impossibility of attending the hospital intervention;
  • Engaging in supervised physical exercise in the past three months;
  • Do not complete the run-in period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIAT
Composite of the execution of moderated-intensity aerobic training (MIAT) twice week.
Other: MIAT
Moderated aerobic exercise
Other: Control
Weekly body relaxation and sham group
Experimental: Control
Consisting of two session per week of different activities, such as body relaxation, low-intesity/volume of aerobic exercise to mimic sham group.
Other: MIAT
Moderated aerobic exercise
Other: Control
Weekly body relaxation and sham group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biological Aging
Time Frame: 16 weeks
Telomere Length
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aerobic Capacity
Time Frame: 16 weeks
Cardiopulmonary Exercise Test - VO2peak
16 weeks
Echocardiography Variables
Time Frame: 16 weeks
Differents echocardiography variables such as Strain Global Longitudinal
16 weeks
Endothelial Function
Time Frame: 16 weeks
Flow-mediated dilation (FMD) of Brachial Artery
16 weeks
SSWS
Time Frame: 16 weeks
Walking Ability measured by a Self-Selected Walking Speed Test (SSWST)
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ricardo Stein, PhD, Hospital de Clinicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

February 15, 2019

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 27, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180651

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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