Symptom-limited Stair Climbing Test in Heart Failure

April 15, 2020 updated by: KTO Karatay University

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

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Thirty-one patients age 65.52±7.57 years with stage II-III according to the NYHA classification, diagnosed with CHF, with a LVEF of 45% or less admitted to study.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2017

Primary Completion (Actual)

November 10, 2017

Study Completion (Actual)

November 12, 2017

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

April 15, 2020

First Posted (Actual)

April 20, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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