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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home-based walking group | Experimental | In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge. |
|
| General health education group | No Intervention | A general routine health education in the hospital before discharge. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home-based walking program | Behavioral | The home-based walking intervention involves five walking sessions per week over 12 weeks, with a target of 3,000 additional steps per session beyond daily activities. In the first week, participants in the experimental group will wear a smart wristband upon waking to record their average daily steps, which will guide their walking goals. By the 7th week, participants are expected to achieve at least 3,000 extra steps per session, completed in 30 continuous minutes. The wristband, synced via Bluetooth to its companion app, can store up to one month of walking data. Weekly phone follow-ups will record participants' daily step counts. No additional cloud uploads of personal data are required. |
| Measure | Description | Time Frame |
|---|---|---|
| Depression (Patient Health Questionnaire-9,PHQ-9) | A state of mood in daily life characterized by a loss of interest or pleasure in activities, accompanied by symptoms such as weight loss or decreased appetite, insomnia or excessive sleep, psychomotor abnormalities or agitation, fatigue or lack of energy, excessive guilt or self-deprecation, difficulty concentrating or making decisions, and suicidal thoughts, plans, or behaviors. Scoring Method： Each response is assigned a score based on the following scale:0 points: Not at all,1 point: Several days,2 points: More than half the days,3 points: Nearly every. PHQ-9 score obtained by adding score for each question (total points). 0-4: Minimal or no depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression Higher scores indicate more severe depressive symptoms, with a score of 10 or above generally suggesting the need for further clinical evaluation or intervention. | baseline, 1 month, 3 months |
| Frailty (CSHA-CFS) | Frailty is defined as a decline in overall physiological resilience, making it difficult to cope with stress or even daily activities. The current criteria for identifying frailty include the presence of at least three of the following five symptoms: reduced grip strength, decreased energy levels, slow walking speed, insufficient physical activity. A score from 1 (very fit) to 9 (terminally ill) is given based on the descriptions and pictographs of activity and functional status. Scoring Description:
| baseline, 1 month, 3 months |
| Quality of Life (Minnesota Living With Heart Failure Questionnaire,MLHFQ) | Quality of life refers to an individual's functional abilities and well-being across physical, psychological, and social domains. Functionality includes physical functions such as self-care (e.g., bathing, dressing, walking); role functions, such as work-related activities like household chores and professional tasks; and social functions, which involve the extent of interaction with family and friends. Well-being, on the other hand, is more subjective than functionality and encompasses emotions such as happiness, sadness, depression, anxiety, pain, and fatigue. Scoring Range: The MLHFQ consists of 21 items, each scored on a scale from 0 to 5. 0: No impact on daily life. 5: Maximum impact on daily life. Total Score: Add the scores for all 21 items to calculate the total score. The total score ranges from 0 to 105, with higher scores indicating a greater negative impact of heart failure on the patient's quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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Participants were randomly assigned using block randomization and divided into an experimental group and a control group.
This study collected data from hospitalized patients in the internal medicine and surgical wards of a medical center in northern Taiwan. Patients who met the following study criteria, as diagnosed and evaluated by a cardiologist, were informed of the research topic, purpose, study duration, and procedures
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| ID | Title | Description |
|---|---|---|
| FG000 | Home-based Walking Group | In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge. |
| FG001 | General Health Education Group | A general routine health education in the hospital before discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who are assigned to groups were not excluded from analyses at baseline
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| ID | Title | Description |
|---|---|---|
| BG000 | Home-based Walking Group | In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge. |
| BG001 | General Health Education Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Participants were divided into age < 60 year-old and >=60 year-old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression (Patient Health Questionnaire-9,PHQ-9) | A state of mood in daily life characterized by a loss of interest or pleasure in activities, accompanied by symptoms such as weight loss or decreased appetite, insomnia or excessive sleep, psychomotor abnormalities or agitation, fatigue or lack of energy, excessive guilt or self-deprecation, difficulty concentrating or making decisions, and suicidal thoughts, plans, or behaviors. Scoring Method： Each response is assigned a score based on the following scale:0 points: Not at all,1 point: Several days,2 points: More than half the days,3 points: Nearly every. PHQ-9 score obtained by adding score for each question (total points). 0-4: Minimal or no depression 5-9: Mild depression 10-14: Moderate depression 15-19: Moderately severe depression 20-27: Severe depression Higher scores indicate more severe depressive symptoms, with a score of 10 or above generally suggesting the need for further clinical evaluation or intervention. | Posted | Mean | Standard Deviation | points | baseline, 1 month, 3 months |
|
From enrollment until end of follow-up, up to 12 weeks (three months)
Adverse events were collected through systematic assessment during the study period, including participant self-report and clinical evaluation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Home-based Walking Group | In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge. |
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Despite randomization, the sample size was small (n=66) and drawn from a single medical center, limiting generalizability. The 12-week intervention may be insufficient to capture long-term changes, particularly in frailty. Exercise assessment relied on step counts, lacking information on intensity and diversity of training. Additionally, self-reported questionnaires may introduce response bias. Future studies should expand sample diversity, extend follow-up duration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chen An Wang | National Taiwan University Hospital | +886932738747 | graceann0513@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 22, 2025 | Mar 30, 2026 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D003863 | Depression |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| baseline, 1 month, 3 months |
A general routine health education in the hospital before discharge.
| BG002 | Total | Total of all reporting groups |
Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Participants were divided into two groups as female and male | Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| NYHA class | Participants were divided into NYHA class II and III | NYHA functional class was used to assess symptom severity, with Class II defined as slight limitation of physical activity and Class III defined as marked limitation. Higher class indicates worse functional status. | Count of Participants | Participants |
|
| Home-based Walking Group |
In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge. |
| OG001 | General Health Education Group | A general routine health education in the hospital before discharge. |
|
|
| Primary | Frailty (CSHA-CFS) | Frailty is defined as a decline in overall physiological resilience, making it difficult to cope with stress or even daily activities. The current criteria for identifying frailty include the presence of at least three of the following five symptoms: reduced grip strength, decreased energy levels, slow walking speed, insufficient physical activity. A score from 1 (very fit) to 9 (terminally ill) is given based on the descriptions and pictographs of activity and functional status. Scoring Description:
| Posted | Mean | Standard Deviation | points | baseline, 1 month, 3 months |
|
|
|
| Primary | Quality of Life (Minnesota Living With Heart Failure Questionnaire,MLHFQ) | Quality of life refers to an individual's functional abilities and well-being across physical, psychological, and social domains. Functionality includes physical functions such as self-care (e.g., bathing, dressing, walking); role functions, such as work-related activities like household chores and professional tasks; and social functions, which involve the extent of interaction with family and friends. Well-being, on the other hand, is more subjective than functionality and encompasses emotions such as happiness, sadness, depression, anxiety, pain, and fatigue. Scoring Range: The MLHFQ consists of 21 items, each scored on a scale from 0 to 5. 0: No impact on daily life. 5: Maximum impact on daily life. Total Score: Add the scores for all 21 items to calculate the total score. The total score ranges from 0 to 105, with higher scores indicating a greater negative impact of heart failure on the patient's quality of life. | Posted | Mean | Standard Deviation | points | baseline, 1 month, 3 months |
|
|
|
| 1 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | General Health Education Group | A general routine health education in the hospital before discharge. | 1 | 34 | 0 | 34 | 0 | 34 |
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| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 3-month |
|
| 3-month |
|