Trial Outcomes & Findings for The Impact of a Home-Based Walking Exercise Program on Heart Failure (NCT NCT06791967)
NCT ID: NCT06791967
Last Updated: 2026-05-12
Results Overview
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.
COMPLETED
NA
68 participants
baseline, 1 month, 3 months
2026-05-12
Participant Flow
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
Participants were randomly assigned using block randomization and divided into an experimental group and a control group.
Participant milestones
| Measure |
Home-based Walking Group
In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge.
|
General Health Education Group
A general routine health education in the hospital before discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
33
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
Baseline characteristics by cohort
| Measure |
Home-based Walking Group
n=34 Participants
In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge.
|
General Health Education Group
n=34 Participants
A general routine health education in the hospital before discharge.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age < 60 year-old
|
18 Participants
n=1512 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
11 Participants
n=504 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
29 Participants
n=2016 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
|
Age, Customized
Age >= 60 year-old
|
16 Participants
n=1512 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
23 Participants
n=504 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
39 Participants
n=2016 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
|
Sex: Female, Male
Female
|
7 Participants
n=1512 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
10 Participants
n=504 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
17 Participants
n=2016 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
|
Sex: Female, Male
Male
|
27 Participants
n=1512 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
24 Participants
n=504 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
51 Participants
n=2016 Participants • Participants who withdrew or were lost to follow-up before this assessment were not included in the analysis.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=1512 Participants
|
34 Participants
n=504 Participants
|
68 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
NYHA class
NYHA class II
|
24 Participants
n=1512 Participants • 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.
|
20 Participants
n=504 Participants • 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.
|
44 Participants
n=2016 Participants • 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.
|
|
NYHA class
NYHA class III
|
10 Participants
n=1512 Participants • 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.
|
14 Participants
n=504 Participants • 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.
|
24 Participants
n=2016 Participants • 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.
|
PRIMARY outcome
Timeframe: baseline, 1 month, 3 monthsA 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.
Outcome measures
| Measure |
Home-based Walking Group
n=34 Participants
In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge.
|
General Health Education Group
n=34 Participants
A general routine health education in the hospital before discharge.
|
|---|---|---|
|
Depression (Patient Health Questionnaire-9,PHQ-9)
Baseline
|
4.62 points
Standard Deviation 3.64
|
5.21 points
Standard Deviation 3.41
|
|
Depression (Patient Health Questionnaire-9,PHQ-9)
1-month
|
2.21 points
Standard Deviation 2.04
|
4.73 points
Standard Deviation 4.05
|
|
Depression (Patient Health Questionnaire-9,PHQ-9)
3-month
|
1.33 points
Standard Deviation 1.32
|
3.58 points
Standard Deviation 3.35
|
PRIMARY outcome
Timeframe: baseline, 1 month, 3 monthsFrailty 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.
Outcome measures
| Measure |
Home-based Walking Group
n=34 Participants
In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge.
|
General Health Education Group
n=34 Participants
A general routine health education in the hospital before discharge.
|
|---|---|---|
|
Frailty (CSHA-CFS)
Baseline
|
1.97 points
Standard Deviation 1.00
|
2.24 points
Standard Deviation 1.08
|
|
Frailty (CSHA-CFS)
1-month
|
1.70 points
Standard Deviation 0.88
|
2.06 points
Standard Deviation 0.93
|
|
Frailty (CSHA-CFS)
3-month
|
1.52 points
Standard Deviation 0.76
|
1.85 points
Standard Deviation 0.87
|
PRIMARY outcome
Timeframe: baseline, 1 month, 3 monthsQuality 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.
Outcome measures
| Measure |
Home-based Walking Group
n=34 Participants
In addition to general health education, patients will receive a 12-week home walking exercise program intervention after discharge.
|
General Health Education Group
n=34 Participants
A general routine health education in the hospital before discharge.
|
|---|---|---|
|
Quality of Life (Minnesota Living With Heart Failure Questionnaire,MLHFQ)
Baseline
|
17.56 points
Standard Deviation 10.24
|
17.68 points
Standard Deviation 15.42
|
|
Quality of Life (Minnesota Living With Heart Failure Questionnaire,MLHFQ)
1-month
|
8.48 points
Standard Deviation 8.28
|
16.88 points
Standard Deviation 10.09
|
|
Quality of Life (Minnesota Living With Heart Failure Questionnaire,MLHFQ)
3-month
|
5.33 points
Standard Deviation 5.57
|
15.09 points
Standard Deviation 8.43
|
Adverse Events
Home-based Walking Group
General Health Education Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place