- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04352426
Symptom-limited Stair Climbing Test in Heart Failure
Effectiveness of Symptom-limited Stair-climbing Test in the Determination of the Exercise Capacity of Patients With Chronic 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.
Study Overview
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Symptom-Limited Stair-Climbing Test(SLSCT)
Time Frame: baseline
|
predicted VO2 max (ml/kg/min)
|
baseline
|
|
Six-Minute Walk Test(6MWT)
Time Frame: baseline
|
predicted VO2 max (ml/kg/min)
|
baseline
|
|
Cardiopulmonary Exercise Test(CPET)
Time Frame: baseline
|
predicted VO2 max (ml/kg/min)
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: immediately after the procedure
|
Heart Rate beats/min
|
immediately after the procedure
|
|
Left Ventricular Ejection Fraction
Time Frame: baseline
|
Ecocardiography
|
baseline
|
|
Blood Pressure
Time Frame: immediately after the procedure
|
Systolic and diastolic blood pressure (mmHg)
|
immediately after the procedure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FVC l/sec
Time Frame: baseline
|
Forced Vital Capacity l/sec
|
baseline
|
|
FEF 25-75 l/sec
Time Frame: baseline
|
Forced Expiratory Flow 25-75 l/sec
|
baseline
|
|
PEF l/sec
Time Frame: baseline
|
Peak Expiratory Flow l/sec
|
baseline
|
|
FEV1 %
Time Frame: baseline
|
Forced Expiratory Volume in One Second %
|
baseline
|
|
FVC %
Time Frame: baseline
|
Forced Vital Capacity %
|
baseline
|
|
FEF 25-75 %
Time Frame: baseline
|
Forced Expiratory Flow %
|
baseline
|
|
PEF %
Time Frame: baseline
|
Peak Expiratory Flow %
|
baseline
|
|
FEV1 l/sec
Time Frame: bseline
|
Forced Vital Capacity l/sec
|
bseline
|
|
FEV1/FVC
Time Frame: bseline
|
FEV1/FVC %
|
bseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- busra.alkan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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