NCT06463496

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

First Submitted

Initial submission to the registry

June 11, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

June 17, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

June 11, 2024

Last Update Submit

January 12, 2026

Conditions

Keywords

Heart FailureBalance FunctionExecutive Function

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Color Trails Test

    T0 : Baseline ; T1: one month after discharge; T2: three months discharge

  • The Stroop Color and Word Test

    T0 : Baseline ; T1: one month after discharge; T2: three months discharge

  • Digit Span Test

    T0 : Baseline ; T1: one month after discharge; T2: three months discharge

Study Arms (2)

Heart failure group

Patients with heart failure in post-acute care program

Healthy control group

The age- and gender-matched healthy control group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Occupational therqapy

Study Record Dates

First Submitted

June 11, 2024

First Posted

June 17, 2024

Study Start

June 17, 2024

Primary Completion

February 28, 2026

Study Completion

February 28, 2026

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations