Symptom-limited Stair Climbing Test in Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352426
• Other study ID #: busra.alkan
• Status: Completed
• Start date: January 13, 2017
• Est. completion date: November 12, 2017

Study information

• Verified date: April 2020
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 12, 2017
• Est. primary completion date: November 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Other:
• Exercise Test
Tests were conducted to evaluate exercise capacity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KTO Karatay University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	FVC l/sec	Forced Vital Capacity l/sec	baseline
Other	FEF 25-75 l/sec	Forced Expiratory Flow 25-75 l/sec	baseline
Other	PEF l/sec	Peak Expiratory Flow l/sec	baseline
Other	FEV1 %	Forced Expiratory Volume in One Second %	baseline
Other	FVC %	Forced Vital Capacity %	baseline
Other	FEF 25-75 %	Forced Expiratory Flow %	baseline
Other	PEF %	Peak Expiratory Flow %	baseline
Other	FEV1 l/sec	Forced Vital Capacity l/sec	bseline
Other	FEV1/FVC	FEV1/FVC %	bseline
Primary	Symptom-Limited Stair-Climbing Test(SLSCT)	predicted VO2 max (ml/kg/min)	baseline
Primary	Six-Minute Walk Test(6MWT)	predicted VO2 max (ml/kg/min)	baseline
Primary	Cardiopulmonary Exercise Test(CPET)	predicted VO2 max (ml/kg/min)	baseline
Secondary	Heart Rate	Heart Rate beats/min	immediately after the procedure
Secondary	Left Ventricular Ejection Fraction	Ecocardiography	baseline
Secondary	Blood Pressure	Systolic and diastolic blood pressure (mmHg)	immediately after the procedure