UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060418 |
|---|---|
| Receipt number | R000068843 |
| Scientific Title | A Randomized Controlled Trial of Step-Count-Targeted Physical Therapy for the Prevention of Hospital-Associated Disability in Elderly Patients After Cardiovascular Surgery. |
| Date of disclosure of the study information | 2026/01/20 |
| Last modified on | 2026/01/20 22:48:05 |
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Basic information
Public title
Effect of Step-Count-Targeted Physical Therapy on Prevention of Hospital-Associated Disability in Elderly Patients After Cardiovascular Surgery: A Randomized Controlled Trial.
Acronym
STEP-HAD Study
Scientific Title
A Randomized Controlled Trial of Step-Count-Targeted Physical Therapy for the Prevention of Hospital-Associated Disability in Elderly Patients After Cardiovascular Surgery.
Scientific Title:Acronym
STEP-HAD Trial
Region
| Japan |
Condition
Condition
Cardiovascular Diseases
Classification by specialty
| Cardiology | Vascular surgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether step-count-targeted physical therapy is effective in preventing hospital-associated disability in elderly patients after cardiovascular surgery.in addition, this study aims to examine whether the effectiveness of the intervention differs according to the degree of surgical invasiveness, including open-heart surgery, minimally invasive cardiac surgery (MICS), transcatheter aortic valve replacement (TAVR), and transcatheter edge-to-edge repair(TEER).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Change in the total Functional independence Measure (FIM) score from preoperative baseline to hospital Discharge.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group step count targeted physical therapy: Participants in the intervention group will receive step count targeted physical therapy in addition to standard physical therapy. The intervention period will start when postoperative walking training is initiated and the participant becomes able to perform independent standing exercises and will continue until hospital discharge. Participants will wear a triaxial accelerometer based activity monitor throughout the day except during bathing. The display of the activity monitor will be turned on so that participants can check their daily step counts. The initial daily step count target will be nine hundred steps or more. Participants who achieve this target will subsequently be encouraged to reach a higher target of one thousand three hundred eight steps or more. articipants will be instructed to perform self directed exercise every day consisting of walking practice or stepping in place when independent walking is not permitted. Daily step counts will be recorded by the participants every night on a step count log sheet. A physical therapist will review the recorded step counts at least once per day during routine physical therapy sessions and will provide encouragement positive feedback and specific guidance to support achievement of the daily step target. Exercise intensity will be prescribed at a Borg rating of perceived exertion level between eleven and thirteen. If any safety related symptoms occur the intervention will be temporarily discontinued and resumption will be considered after clinical stabilization.
Interventions/Control_2
Control group standard physical therapy: Participants in the control group will receive standard physical therapy alone according to institutional practice. They will wear the same activity monitor but the display will be turned off and no feedback regarding step counts or physical activity will be provided.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients hospitalized at the study institution who are prescribed physical therapy by a physician
2.Patients scheduled to undergo elective open-heart surgery, minimally invasive cardiac surgery (MICS), transcatheter aortic valve replacement (TAVR), or transcatheter edge-to-edge repair (TEER)
3.Aged 65 years or older
4.Patients who have undergone a preoperative physical therapy assessment
5.Patients who have provided written informed consent to participate in the study
Key exclusion criteria
1 Patients who underwent emergency surgery
2 Patients with delayed extubation lasting more than forty eight hours
3 Patients with preoperative cognitive impairment defined as a Mini Mental State Examination score of twenty three or lower
4 Patients with preoperative functional dependency defined as a Barthel Index score of less than eighty five or a Functional Independence Measure score of less than eighty eight
5 Patients who developed postoperative cerebral infarction
6 Patients with uncontrolled arrhythmias or uncontrolled hypertension
7 Patients judged to be unsuitable for study participation by the principal investigator
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Kazama |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Department of Rehabilitation
Zip code
3710004
Address
3-12 Kameizumimachi, Maebashi, Gunma, Japan
TEL
0272697455
kazamahiroko1031@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Kazama |
Organization
Gunma Prefectural Cardiovascular Center
Division name
Departmento of Rehabilitation
Zip code
3710004
Address
3-12 Kameizumimachi, Maebashi, Gunma, Japan
TEL
0272697455
Homepage URL
kazamahiroko1031@yahoo.co.jp
Sponsor or person
Institute
Gunma Prefectural Cardiovascular Center, Department of Rehabilitation
Institute
Department
Personal name
Kazama Hiroko
Funding Source
Organization
Gunma Prefectural Cardiovascular Center, Department of Rehabilitation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Prefectural Cardiovascular Center
Address
3-12 Kameizumimachi, Maebashi, Gunma, Japan
Tel
0272697455
kazamahiroko1031@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
群馬県立心臓血管センター（群馬県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 20 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068843
