NCT04352426

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 20, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

April 6, 2020

Last Update Submit

April 15, 2020

Conditions

Keywords

chronic heart failureexercise capacitysymptom-limited stair-climbing test

Outcome Measures

Primary Outcomes (3)

  • Symptom-Limited Stair-Climbing Test(SLSCT)

    predicted VO2 max (ml/kg/min)

    baseline

  • Six-Minute Walk Test(6MWT)

    predicted VO2 max (ml/kg/min)

    baseline

  • Cardiopulmonary Exercise Test(CPET)

    predicted VO2 max (ml/kg/min)

    baseline

Secondary Outcomes (3)

  • Heart Rate

    immediately after the procedure

  • Left Ventricular Ejection Fraction

    baseline

  • Blood Pressure

    immediately after the procedure

Other Outcomes (9)

  • FVC l/sec

    baseline

  • FEF 25-75 l/sec

    baseline

  • PEF l/sec

    baseline

  • +6 more other outcomes

Interventions

Tests were conducted to evaluate exercise capacity.

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

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

Study Record Dates

First Submitted

April 6, 2020

First Posted

April 20, 2020

Study Start

January 13, 2017

Primary Completion

November 10, 2017

Study Completion

November 12, 2017

Last Updated

April 20, 2020

Record last verified: 2020-04