NCT07128784

Brief Summary

The goal of this observational study is to learn about the short-term effects of aerobic exercise in heart failure patients who were given exercise prescription with cardiopulmonary exercise stres test acocording to aerobic capacity . The main question it aims to answer is: Does aerobic exercise increase aerobic capacity and quality of life Participants already taking aerobic capacity as part of their regular medical care for Heart failure will asses with cardiopulmonary exercise test and clinical questionaries about quality of life and depression-anxiety level before and after aerobic exercise treatment .

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

June 12, 2025

Last Update Submit

August 11, 2025

Conditions

Keywords

cardiopulmonary exercise testaerobic capacityaerobic exerciseheart failure

Outcome Measures

Primary Outcomes (4)

  • cardiopulmonary exercise test results

    Cardiovascular responses: VO2 max value (ml/kg/dk)

    6 weeks

  • cardiopulmonary exercise test results

    Cardiovascular responses: heart rate (bpm, beats/min)

    6 weeks

  • cardiopulmonary exercise test results

    gas exchange response: VE/VCO2: EQCO2: Ventilatory equivalent for carbon dioxide minute ventilation while the produced CO₂ is removed,

    6 weeks

  • cardiovascular exercise test result: Gas exchange parameters:

    PETCO₂ (partial end-tidal carbon dioxide), kilopascal

    6 weeks

Secondary Outcomes (2)

  • Short Form (36) Health Scale

    6 weeks

  • Hospital Anxiety and Depression Scale

    6 weeks

Study Arms (1)

aerobic exercise

Other: Aerobic exercise

Interventions

continuous, moderate intencity aerobic exercise, 3 days a week, 30 minutes per day, 150/min per week for a total of 6 weeks

aerobic exercise

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18-75 age of years , male and female , diagnosed with heart failure with reduced EF

You may qualify if:

  • Age 18-75,
  • Diagnosed with compensated HF,
  • BMI 18-30 kg/m²,
  • LVEF \< 0.4,
  • NYHA 2-3,
  • Clinical symptoms have been stable for at least 2 weeks, and the dose of angiotensin-converting enzyme inhibitor/angiotensin receptor antagonist/angiotensin receptor inhibitor, beta-blocker, aldosterone inhibitor, and other drugs has been stable for at least 2 weeks.

You may not qualify if:

  • History of a heart implant device within the last 6 weeks or a heart implant device or heart transplant plan within the next 12 months,
  • Acute coronary syndrome within the last 6 weeks, severe valvular heart disease, congenital heart disease, severe hypertrophic obstructive cardiomyopathy, acute myocarditis/pericarditis, intracardiac thrombosis, primary pulmonary hypertension,
  • Uncontrolled hypertension (systolic blood pressure \>200 mmHg and/or diastolic blood pressure \>110 mmHg),
  • Severe arrhythmias such as ventricular tachycardia, frequent multisource premature ventricular beats, high atrioventricular block, and significant QT interval prolongation during exercise testing,
  • Progressive dyspnea or
  • Loss of exercise endurance at rest within the last 3-5 days under low-intensity exercise load (\<2 MET) who have suffered myocardial ischemia,
  • Patients with cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (2)

  • Lelonek M. Heart failure with preserved ejection fraction after the PARAGON-HF trial results: current knowledge and future directions. Kardiol Pol. 2020 Dec 23;78(12):1199-1205. doi: 10.33963/KP.15639. Epub 2020 Oct 6.

    PMID: 33021355BACKGROUND
  • Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.

    PMID: 29174292BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2025

First Posted

August 19, 2025

Study Start

April 1, 2025

Primary Completion

June 15, 2025

Study Completion

June 20, 2025

Last Updated

August 19, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations