NCT03856736

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
2 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

February 15, 2019

Last Update Submit

January 8, 2021

Conditions

Keywords

Heart FailureTelomere LengthAerobic Exercise

Outcome Measures

Primary Outcomes (1)

  • Biological Aging

    Telomere Length

    16 weeks

Secondary Outcomes (4)

  • Aerobic Capacity

    16 weeks

  • Echocardiography Variables

    16 weeks

  • Endothelial Function

    16 weeks

  • SSWS

    16 weeks

Study Arms (2)

MIAT

EXPERIMENTAL

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

Other: MIATOther: Control

Control

EXPERIMENTAL

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

Other: MIATOther: Control

Interventions

MIATOTHER

Moderated aerobic exercise

ControlMIAT
ControlOTHER

Weekly body relaxation and sham group

ControlMIAT

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ricardo Stein, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leandro T Franzoni

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2019

First Posted

February 27, 2019

Study Start

March 1, 2021

Primary Completion

August 30, 2021

Study Completion

December 30, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations