Clinical trial NCT06791967: The Impact of a Home-Based Walking Exercise Program on Heart Failure
Official title: Effectiveness of a Home-base Walking Exercise Program on Depression,Frailty,and Quality of Life in Patients with Heart Failure: a Single-Center Randomized-Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heart Failure
Home-based Walking Excercise
Depression
Frailty
Quality of Life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Heart disease is the second leading cause of death in Taiwan, with approximately 700,000 individuals affected by heart failure. Despite the proven benefits of rehabilitative exercise, participation in cardiac rehabilitation remains suboptimal. To address this, integrating physical activity into daily life, such as home-based walking exercises, offers a practical alternative to promote health and improve outcomes in heart failure patients. Walking exercises have been shown to significantly impact mortality rates and enhance the quality of life in this population.

This study aims to assess the effects of a 12-week home-based walking exercise program on depression, frailty, and quality of life in patients with heart failure. Using an experimental design, heart failure patients hospitalized in a medical center's internal medicine ward were randomly divided into an experimental group (n=34) and a control group (n=34). While both groups received standard health education, the experimental group also participated in a home-based walking intervention after discharge. Data were collected before the intervention and at the 1st and 3rd months post-intervention. The generalized estimation equation (GEE) was employed to analyze changes in depression, frailty, and quality of life, focusing on group differences and interactions between time and group.

The expected outcomes of the study include improved quality of life, reduced frailty, and alleviated depression in the experimental group, highlighting the value of home-based walking exercise. Additionally, the intervention model can complement existing post-discharge nursing practices by incorporating remote nursing guidance to enhance exercise adherence without increasing healthcare costs. This approach not only benefits patients by encouraging long-term physical activity but also reduces the burden on healthcare systems, making it a sustainable and effective strategy for managing heart failure.

Detailed description: Background: According to statistics from the Ministry of Health and Welfare, heart disease ranks second among the top ten causes of death in the nation. It is estimated that approximately 700,000 people in Taiwan suffer from heart failure. Despite research confirming the multiple benefits of rehabilitative exercise, actual patient participation in rehabilitation is not ideal. Therefore, incorporating physical activities from daily life as an alternative method can promote the clinical value and practical significance of home-based walking exercise. Walking exercise has a significant impact on the mortality rate and quality of life of patients with heart failure.

Objective: This study aims to investigate the benefits of a home-based walking exercise intervention on depression, frailty, and quality of life in patients with heart failure.

Methods: The study adopts an experimental research design, targeting heart failure patients hospitalized in the internal medicine ward of a medical center in northern Taiwan. Participants were randomly assigned to either the control group (n=34) or the experimental group (n=34). In addition to receiving standard health education, the experimental group participated in a 12-week home-based walking exercise program after discharge. The control group received standard health education once before discharge. Data were analyzed using the generalized estimation equation (GEE) to examine the variables of depression, frailty, and quality of life in both the experimental and control groups before the intervention, and at the 1st and 3rd months post- intervention. The analysis focused on group effects and the interaction between group and time.

Expected Clinical Practice Applications: Based on past literature analysis, home-based walking exercise combined with remote nursing guidance is expected to improve the quality of life, reduce frailty, and alleviate depression in patients with heart failure. Patients can significantly benefit from performing walking exercises at home, while also reducing the clinical workload and costs associated with cardiac rehabilitation for healthcare providers. The intervention model from this study can coexist with current post-discharge nursing follow-up practices. By encouraging continuous home-based walking exercises through remote nursing guidance, the approach ensures ongoing care and personalized nursing without incurring additional nursing costs, thereby effectively enhancing patients' willingness to engage in exercise.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with heart failure classified as New York Heart Association (NYHA) Functional Class II-III by a physician.
* Approval from the attending physician to participate in the home-based walking program after discharge.
* Aged between 18 and 80 years.
* Patients unable to attend outpatient cardiac rehabilitation.
* No regular exercise habits, such as performing less than 30 minutes of aerobic exercise per week.
* Able to walk independently without the aid of assistive devices.
* Patients with clear consciousness, no cognitive impairment, and no history of mental illness.
* Able to communicate in Mandarin or Taiwanese dialect.
* Willing to participate in the study, sign the informed consent form, and comply with the home-based walking program.

Exclusion Criteria:

* Patients diagnosed with heart failure classified as New York Heart Association (NYHA) functional class IV by a physician.
* Patients diagnosed with depression by a psychiatrist.
* Patients with cognitive impairment or language communication disorders.
* Patients who are bedridden for an extended period.

Primary outcomes:
measure: Depression (Patient Health Questionnaire-9,PHQ-9)
timeFrame: baseline, 1 month, 3 months
measure: Frailty (CSHA-CFS)
timeFrame: baseline, 1 month, 3 months
measure: Quality of Life (Minnesota Living With Heart Failure Questionnaire,MLHFQ)
timeFrame: baseline, 1 month, 3 months
Secondary outcomes:
Other outcomes:
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