Heart FailureNCT06791967
The Impact of a Home-Based Walking Exercise Program on Heart Failure
A study testing home-based walking program in people with Heart Failure and Home-based Walking Excercise, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure, Home-based Walking Excercise, Depression
- What is being tested?
- home-based walking program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Mar 2025to 13 Feb 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- home-based walking program
- Medical subject headings
- Heart Failure, Depression, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based walking programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Home-based walking group | Experimental | In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge. Receives: Behavioral: home-based walking program |
| General health education group | No intervention | A general routine health education in the hospital before discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- Very Fit
- Fit
- Managing Well
- Living with Very Mild Frailty
- Living with Mild Frailty
- Living with Moderate Frailty
- Living with Severe Frailty
- Living with Very Severe Frailty
- Terminally Ill In the CSHA-CFS assessment, higher scores indicate greater frailty. A score of 1 reflects very fit individuals, while a score of 9 indicates terminal illness and full dependency. Mid-range scores (4-6) signify moderate frailty with functional limitations.
Measured: 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.
Measured: baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start2 Mar 2025
- Primary completion25 Jul 2025
- Study completion13 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06791967
- Sponsor's protocol ID
- 202407218RIND
- Status last verified
- Mar 2026
- First submitted
- 12 Jan 2025
- Last updated
- 12 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06791967
- Acronym / sponsor ID
- 202407218RIND
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 24 Jan 2025 (actual)
- Results
- Posted 12 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based walking group | Experimental | Behavioral: home-based walking programIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based walking programThe 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. | Behavioural | Home-based walking group |
Primary outcome
Depression (Patient Health Questionnaire-9,PHQ-9)
Time frame: baseline, 1 month, 3 months
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.
Frailty (CSHA-CFS)
Time frame: baseline, 1 month, 3 months
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: 1. Very Fit 2. Fit 3. Managing Well 4. Living with Very Mild Frailty 5. Living with Mild Frailty 6. Living with Moderate Frailty 7. Living with Severe Frailty 8. Living with Very Severe Frailty 9. Terminally Ill In the CSHA-CFS assessment, higher scores indicate greater frailty. A score of 1 reflects very fit individuals, while a score of 9 indicates terminal illness and full dependency. Mid-range scores (4-6) signify moderate frailty with functional limitations.
Quality of Life (Minnesota Living With Heart Failure Questionnaire,MLHFQ)
Time frame: baseline, 1 month, 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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?
A study testing home-based walking program in people with Heart Failure and Home-based Walking Excercise, run by National Taiwan University Hospital 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 12 May 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?
Yes. Results are posted in the registry (first posted 12 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression (Patient Health Questionnaire-9,PHQ-9) (time frame: baseline, 1 month, 3 months). The study lists 3 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 12 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.