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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06463496
• Other study ID #: KSVGH24-CT6-08
• Status: Not yet recruiting
• Start date: June 17, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Kaohsiung Veterans General Hospital.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Veterans General Hospital.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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