Balance and Executive Function in Middle-age and Older Patients With Heart Failure in Post-Acute Care Program

This trial is a single-center clinical trial in Taiwan with an expected enrollment of 60 people in Taiwan. The purpose of this trial is to compare the performance of middle-aged and elderly patients with subacute heart failure with that of a healthy control group in terms of balance function and executive function, as well as to investigate whether there is a correlation between balance function and executive function in middle-aged and elderly patients with heart failure and to track the changes in balance and executive function one month and three months after discharge from the hospital. Please think carefully before deciding whether to participate in this trial.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung City, Taiwan
    • Kaohsiung Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

1. Middle-aged and older patients with heart failure in in Post-Acute Care Program

Description

Inclusion Criteria:

• Diagnosed with heart failure and receiving post-acute care program for heart failure
• Left ventricular ejection fraction≦40%
• Age ≥ 45
• No cognitive impairment
• Ambulate independently or with the use of aids
• Clinical symptoms are stable
• Voluntary participation

Exclusion Criteria:

• Use of medications that cause dizziness or interfere with balance
• Have other diagnoses that may affect balance, such as stroke, Parkinson's disease
• Color blindness, severe hearing or visual impairment that prevents reading questions and listening to instructions

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Heart failure group; Patients with heart failure in post-acute care program
Healthy control group; The age- and gender-matched healthy control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	The balance function will be evaluated using the Berg Balance Scale. Berg Balance Scale have 14 subtests, each of which is scored on a scale of 0 to 4, for a total score of 56, with higher scores indicating better balance.	T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Timed Up and Go Test	The balance function will be evaluated using the Timed Up and Go Test. Timed Up and Go Test use a chronograph to measure the total time spent (in seconds), with less time representing better ability.	T0 : Baseline ； T1: one month after discharge； T2: three months discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Color Trails Test	The Working memory will be evaluated using Color Trails Test. Scoring is based on the total number of seconds to complete the test. Lower scores represent greater difficulty inWorking memory .	T0 : Baseline ； T1: one month after discharge； T2: three months discharge
The Stroop Color and Word Test	The Inhibitor Control will be evaluated using the Stroop Color and Word Test. The test consisted of three parts, each spanning 45 s where participants read out as many colour words such as ''red, green, blue and purple'' or coloured items words as possible. Number of items corrected and wrongly read out were used to compute the predicted colour-word (Pcw) and interference (IF).Lower scores represent greater difficulty in inhibiting incongruence.	T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Digit Span Test	The Cognitive flexibility will be evaluated using the Digit Span test. The scores range from 0 to 45. Lower scores represent greater difficulty in Cognitive flexibility .	T0 : Baseline ； T1: one month after discharge； T2: three months discharge

Collaborators and Investigators

• Sponsor: Chang Chia-Jung
• Collaborators: Kaohsiung Veterans General Hospital.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Estimated): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Heart Failure; Executive Function; Balance Function
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: KSVGH24-CT6-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No