Heart FailureNCT06463496
Balance and Executive Function in Middle-age and Older Patients With Heart Failure in Post-Acute Care Program
An observational study of Heart Failure, run by Chang Chia-Jung at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jun 2024to 28 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. Middle-aged and older patients with heart failure in in Post-Acute Care Program
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Balance Function, Executive Function
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Secondary outcomes (3)
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 .
Measured: 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.
Measured: 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 .
Measured: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start17 Jun 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Chia-Jung
- Sponsor type
- University, hospital or other
- Collaborators
- Kaohsiung Veterans General Hospital.
- Responsible party
- Sponsor-investigator, Chang Chia-Jung, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463496
- Sponsor's protocol ID
- KSVGH24-CT6-08
- Status last verified
- Jan 2026
- First submitted
- 11 Jun 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance and Executive Function in Middle-age and Older Patients With Heart Failure in Post-Acute Care Program
- ClinicalTrials.gov ID
- NCT06463496
- Acronym / sponsor ID
- KSVGH24-CT6-08
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Balance Function, Executive Function
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Chia-JungUniversity, hospital or other
- Collaborators
- Kaohsiung Veterans General Hospital.
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart failure group | – | –Patients with heart failure in post-acute care program |
| Healthy control group | – | –The age- and gender-matched healthy control group |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Middle-aged and older patients with heart failure in in Post-Acute Care Program
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Color Trails Test
Time frame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
The Stroop Color and Word Test
Time frame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Digit Span Test
Time frame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Chang Chia-Jung at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: T0 : Baseline ； T1: one month after discharge； T2: three months discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.