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NCT Number: NCT04352426

Symptom-limited Stair Climbing Test in Heart Failure

Aims: To assess the efficacy of symptom-limited stair-climbing test (SLSCT), in determining the exercise capacities of patients with chronic heart failure (CHF) in comparison with cardiopulmonary exercise test (CPET) and 6-minute walk test(6MWT) and to interpret the results according to the clinical status of the patients.

Methods: Thirty-one patients, aged 50-75 years, with stage II-III CHF according to the New York Heart Association Classification and left ventricular ejection fraction (LVEF) of ≤45% were included. The demographic and clinical characteristics of the patients were recorded. Exercise capacity was assessed by SLSCT, 6MWT, and CPET. The duration of patients' performance in the test, reasons for ending the test and predicted maximal oxygen consumption (VO2max) were recorded. Heart rate (HR), blood pressure (BP), dyspnoea severity [Modified Borg Scale (MBS)] and peripheral oxygen saturation were recorded. Pulmonary functions were assessed by spirometry.

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Key information

Conditions

Chronic Heart Failure

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 50-75 years of age
  • NYHA stage II-III
  • LVEF of 45% or less
  • Independently walking and climbing stairs
  • Volunteer to participate in research

Exclusion criteria

  • Any acute or chronic condition that would limit exercise capacity other than CHF
  • Insufficient mental status to perform tests and surveys
  • Orthopaedic problem limiting exercise test in lower extremity
  • Severe obesity or there is a secondary cause for obesity
  • Uncontrolled cardiac arrhythmia
  • Unstable angina

Treatment and study plan

Exercise test

Other

Tests were conducted to evaluate exercise capacity.

Primary outcomes

  1. Symptom-Limited Stair-Climbing Test(SLSCT)

    Time frame: baseline

    predicted VO2 max (ml/kg/min)

  2. Six-Minute Walk Test(6MWT)

    Time frame: baseline

    predicted VO2 max (ml/kg/min)

  3. Cardiopulmonary Exercise Test(CPET)

    Time frame: baseline

    predicted VO2 max (ml/kg/min)

Secondary outcomes

  1. Heart Rate

    Time frame: immediately after the procedure

    Heart Rate beats/min

  2. Left Ventricular Ejection Fraction

    Time frame: baseline

    Ecocardiography

  3. Blood Pressure

    Time frame: immediately after the procedure

    Systolic and diastolic blood pressure (mmHg)

Other outcomes

  1. FVC l/sec

    Time frame: baseline

    Forced Vital Capacity l/sec

  2. FEF 25-75 l/sec

    Time frame: baseline

    Forced Expiratory Flow 25-75 l/sec

  3. PEF l/sec

    Time frame: baseline

    Peak Expiratory Flow l/sec

  4. FEV1 %

    Time frame: baseline

    Forced Expiratory Volume in One Second %

  5. FVC %

    Time frame: baseline

    Forced Vital Capacity %

  6. FEF 25-75 %

    Time frame: baseline

    Forced Expiratory Flow %

  7. PEF %

    Time frame: baseline

    Peak Expiratory Flow %

  8. FEV1 l/sec

    Time frame: bseline

    Forced Vital Capacity l/sec

  9. FEV1/FVC

    Time frame: bseline

    FEV1/FVC %

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

Effectiveness of Symptom-limited Stair-climbing Test in the Determination of the Exercise Capacity of Patients With Chronic Heart Failure

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 20, 2020
Registry last updated
Apr 20, 2020

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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