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NCT Number: NCT06463496

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Berg Balance Scale

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

    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.

  2. Timed Up and Go Test

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

    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.

Secondary outcomes

  1. Color Trails Test

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

    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 .

  2. The Stroop Color and Word Test

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

    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.

  3. Digit Span Test

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

    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 .

Sponsors and collaborators

Lead sponsor

Chang Chia-Jung

Other

Collaborators

  • Kaohsiung Veterans General Hospital.

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2024
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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