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Aerobic Exercise and Telomere Length in Patients With Heart Failure.

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
MIAT
Control
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Telomere Length, Aerobic Exercise

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MIAT

Control

Arm Description

Composite of the execution of moderated-intensity aerobic training (MIAT) twice week.

Consisting of two session per week of different activities, such as body relaxation, low-intesity/volume of aerobic exercise to mimic sham group.

Outcomes

Primary Outcome Measures

Biological Aging
Telomere Length

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2019
Last Updated
January 8, 2021
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03856736
Brief Title
Aerobic Exercise and Telomere Length in Patients With Heart Failure.
Official Title
Effects of Aerobic Exercise on Telomere Length in Patients With Systolic Heart Failure: A Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Anticipated)
Primary Completion Date
August 30, 2021 (Anticipated)
Study Completion Date
December 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Telomere Length, Aerobic Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MIAT
Arm Type
Experimental
Arm Description
Composite of the execution of moderated-intensity aerobic training (MIAT) twice week.
Arm Title
Control
Arm Type
Experimental
Arm Description
Consisting of two session per week of different activities, such as body relaxation, low-intesity/volume of aerobic exercise to mimic sham group.
Intervention Type
Other
Intervention Name(s)
MIAT
Intervention Description
Moderated aerobic exercise
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Weekly body relaxation and sham group
Primary Outcome Measure Information:
Title
Biological Aging
Description
Telomere Length
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Aerobic Capacity
Description
Cardiopulmonary Exercise Test - VO2peak
Time Frame
16 weeks
Title
Echocardiography Variables
Description
Differents echocardiography variables such as Strain Global Longitudinal
Time Frame
16 weeks
Title
Endothelial Function
Description
Flow-mediated dilation (FMD) of Brachial Artery
Time Frame
16 weeks
Title
SSWS
Description
Walking Ability measured by a Self-Selected Walking Speed Test (SSWST)
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Leandro T Franzoni
Phone
555133597634
Email
lfranzoni@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Stein, PhD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035903
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leandro T Franzoni
Phone
5133597634
Email
lfranzoni@hcpa.edu.br

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35410445
Citation
Franzoni LT, Garcia EL, Motta SB, Ahner MM, Bertoletti OA, Saffi MAL, da Silveira AD, Pereira AA, Pereira AH, Danzmann LC, Stein R. Aerobic exercise and telomere length in patients with systolic heart failure: protocol study for a randomized controlled trial. Trials. 2022 Apr 11;23(1):283. doi: 10.1186/s13063-022-06257-1.
Results Reference
derived

Learn more about this trial

Aerobic Exercise and Telomere Length in Patients With Heart Failure.

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