The Impact of a Home-Based Walking Exercise Program on Heart Failure

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

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

Conditions

Heart Failure, Home-based Walking Excercise, Depression, Frailty, Quality of Life

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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:

   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.

   Measured: baseline, 1 month, 3 months

3. 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.

1. First posted24 Jan 2025
2. Study start2 Mar 2025
3. Primary completion25 Jul 2025
4. 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.