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NCT Number: NCT07128784

Aerobic Training and Cardiopulmonary Responses In Heart Failure

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 .

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Aerobic Exercise

Other

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

Primary outcomes

  1. cardiopulmonary exercise test results

    Time frame: 6 weeks

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

  2. cardiopulmonary exercise test results

    Time frame: 6 weeks

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

  3. cardiopulmonary exercise test results

    Time frame: 6 weeks

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

  4. cardiovascular exercise test result: Gas exchange parameters:

    Time frame: 6 weeks

    PETCO₂ (partial end-tidal carbon dioxide), kilopascal

Secondary outcomes

  1. Short Form (36) Health Scale

    Time frame: 6 weeks

    Short Form (36) Health Scale

    Description:

    The SF-36 is a widely used, patient-reported survey of health status designed to assess overall health-related quality of life. It evaluates physical and mental health across multiple dimensions and is commonly used in clinical research and health outcomes studies.

    Domains Assessed (8 Subscales): Physical Functioning , Role Limitations due to Physical Health,Pain, General Health Perceptions Vitality, Social Functioning, Role Limitations due to Emotional Problems, Mental Health

    These can also be summarized into two main component scores:

    Physical Component Summary (PCS) Mental Component Summary (MCS)

    Scoring Range:

    Each subscale is scored from 0 to 100. 0 represents the worst possible health status; 100 represents the best possible health status.

    Interpretation of Scores:

    Higher scores indicate better health outcomes and higher quality of life, lower scores reflect poorer perceived healt

  2. Hospital Anxiety and Depression Scale

    Time frame: 6 weeks

    The Hospital Anxiety and Depression Scale (HADS) is a self-assessment tool developed to detect states of anxiety and depression in patients in non-psychiatric hospital clinics. It is widely used in both clinical practice and research settings to screen for emotional distress, especially in individuals with physical illnesses.

    Structure:

    The scale consists of 14 items, divided into two subscales:

    HADS-A (Anxiety) - 7 items HADS-D (Depression) - 7 items Each item assesses symptoms experienced over the past week.

    Scoring Range:

    Each item is scored from 0 to 3. Subscale scores range from 0 to 21 for both anxiety and depression.

    Interpretation of Scores (per subscale):

    0-7: Normal 8-10: Borderline abnormal (mild) 11-21: Abnormal (clinically significant)

    Direction of Scores:

    Higher scores indicate greater severity of anxiety or depression symptoms. Lower scores suggest fewer or no symptoms.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

The Impact of Aerobic Exercise Training on Cardiopulmonary Exercise Capacity in Patients With Heart Failure

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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