UMIN-ICDS Clinical Trial

Public title

Effects of Monthly Exercise Guidance in Elderly Patients with Heart Failure

Acronym

HF-STEP

Scientific Title

A Prospective Observational Study of Monthly Exercise Guidance in Elderly Patients with Heart Failure

Scientific Title:Acronym

HF-STEP

Region

Japan

Condition

Heart failure

Classification by specialty

Cardiology

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Exercise therapy is recommended after discharge for older patients with heart failure; however, participation in outpatient cardiac rehabilitation remains limited. The purpose of this prospective study is to investigate the effects of a low-frequency exercise guidance program consisting of monthly exercise counseling on physical function, daily functioning, life-space mobility, health-related quality of life, psychological status, and clinical outcomes in elderly patients with heart failure. In participants with family caregivers, caregiver burden will also be explored. In addition, a predefined subgroup analysis will be performed in patients with a discharge Short Physical Performance Battery (SPPB) score of 10 or lower.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in Short Physical Performance Battery (SPPB) score at 6 months

Key secondary outcomes

Changes in handgrip strength, body composition, Performance Measure for Activities of Daily Living (PMADL-8), Home-based Life-Space Assessment (Hb-LSA), daily step counts, EuroQol 5 Dimensions 5 Levels (EQ-5D-5L), Patient Health Questionnaire-9 (PHQ-9), and Zarit Burden Interview at 6 months, as well as heart failure rehospitalization and all-cause mortality within 1 year.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients aged 65 years or older with heart failure
2. Patients discharged home after hospitalization for heart failure
3. Ability to attend outpatient visits
4. Patients who received outpatient exercise guidance

Key exclusion criteria

1. Contraindication to exercise therapy determined by the attending physician
2. Severe cognitive impairment preventing study assessment
3. Expected difficulty in completing follow-up
4. Any condition judged by the investigators to make participation inappropriate

Target sample size

100

Name of lead principal investigator

1st name	Taku
Middle name
Last name	Kobayashi

Organization

Minamino Cardiovascular Hospital

Division name

Department of Rehabilitation

Zip code

192-0918

Address

1-25-1 Hyoe, Hachioji, Tokyo, Japan TEL

TEL

042-637-8101

Email

taku.k@minaminohc.jp

Name of contact person

1st name	Taku
Middle name
Last name	Kobayashi

Organization

Minamino Cardiovascular Hospital

Division name

Department of Rehabilitation

Zip code

192-0918

Address

1-25-1 Hyoe, Hachioji, Tokyo, Japan

TEL

042-637-8101

Homepage URL

Email

taku.k@minaminohc.jp

Institute

Minamino Cardiovascular Hospital

Institute

Department

Personal name

Organization

Minamino Cardiovascular Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Minamino Cardiovascular Hospital

Address

1-25-1 Hyoe, Hachioji, Tokyo, Japan

Tel

042-637-8101

Email

taku.k@minaminohc.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2030

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a single-center prospective observational study. Patients aged 65 years or older who are discharged after hospitalization for heart failure will be enrolled. Monthly exercise guidance will be provided after discharge. Physical function (SPPB and handgrip strength), body composition, physical activity, life-space mobility, activities of daily living, health-related quality of life, depressive symptoms, rehospitalization, and mortality will be assessed longitudinally to evaluate the effectiveness of exercise guidance. Caregiver burden will also be assessed in participants with family caregivers.

Registered date

2026

Year

06

Month

18

Day

Last modified on

2026

Year

06

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070743