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Status unknownNCT03856736Updated Jan 11, 2021

Aerobic Exercise and Telomere Length in Patients With Heart Failure.

An interventional study of MIAT and Control in Heart Failure, sponsored by Hospital de Clinicas de Porto Alegre. Status unknown at 1 site in Brazil. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-11.

Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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).

02

Conditions studied

  • Heart Failure

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Keywords

  • Heart Failure
  • Telomere Length
  • Aerobic Exercise
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's planned enrollment of 24 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Hospital de Clinicas de Porto Alegre is the lead sponsor of 450 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    MIAT

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

    Other: MIAT · Other: Control

  • 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 · Other: Control

Interventions

  • OtherMIAT

    Moderated aerobic exercise

  • OtherControl

    Weekly body relaxation and sham group

06

What researchers measure

Primary outcomes

  1. Biological Aging

    Telomere Length

    Time frame: 16 weeks

Secondary outcomes

  1. Aerobic Capacity

    Cardiopulmonary Exercise Test - VO2peak

    Time frame: 16 weeks

  2. Echocardiography Variables

    Differents echocardiography variables such as Strain Global Longitudinal

    Time frame: 16 weeks

  3. Endothelial Function

    Flow-mediated dilation (FMD) of Brachial Artery

    Time frame: 16 weeks

  4. SSWS

    Walking Ability measured by a Self-Selected Walking Speed Test (SSWST)

    Time frame: 16 weeks

07

Study locations

1 site
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, RS 90035903, Brazil
08

References and documents

Publications

  • 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. PubMed 35410445 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 11, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03856736
Lead sponsor
Hospital de Clinicas de Porto Alegre
Responsible party
Sponsor
First posted
Feb 27, 2019
Start date
Mar 1, 2021 (estimated)
Primary completion
Aug 30, 2021 (estimated)
Completion
Dec 30, 2021 (estimated)
Last update
Jan 11, 2021

Study contacts

Leandro T Franzoni
Contact
lfranzoni@hcpa.edu.br
555133597634
Ricardo Stein, PhD
principal investigator · Hospital de Clínicas de Porto Alegre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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