UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053775 |
|---|---|
| Receipt number | R000061110 |
| Scientific Title | Impact of Online Support of Physical Activity Management Using a Wearable Device on Renal Function in Patients with Acute Coronary Syndrome: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/03/05 |
| Last modified on | 2024/03/04 21:17:04 |
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Basic information
Public title
Impact of Online Support of Physical Activity Management Using a Wearable Device on Renal Function in Patients with Acute Coronary Syndrome
Acronym
Impact of Online Support of Physical Activity Management on Renal Function in ACS Patients
Scientific Title
Impact of Online Support of Physical Activity Management Using a Wearable Device on Renal Function in Patients with Acute Coronary Syndrome: A Randomized Controlled Trial
Scientific Title:Acronym
Impact of Online Support of Physical Activity Management on Renal Function in ACS Patients
Region
| Japan |
Condition
Condition
Acute coronary syndrome
Classification by specialty
| Cardiology | Nephrology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A primary purpose of this study is to determine the impact of an online support of physical activity management using a wearable device on renal function in patients with acute coronary syndrome (ACS).
Basic objectives2
Others
Basic objectives -Others
A secondary purpose is to clarify the impact of an online support of physical activity management on other factors such as cardiac function, physical function, and quality of life, and to test whether this could be an alternative intervention available to ACS patients who have difficulty participating in outpatient cardiac rehabilitation.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
estimated glomerular filtration rate calculated by serum cystatin C (eGFRcys)
Key secondary outcomes
Urine albumin/creatinine ratio, brain natriuretic peptide, average number of steps, peak oxygen uptake, quality of life (EQ-5D), and incidence of adverse events
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
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group (online support of physical activity management)
The online support of physical activity management in this study will be implemented for 3 months starting at the time of discharge from the hospital. Patients in the intervention group will manage their own physical activity based on educational support by a physical therapist. Patients in the intervention group will receive a wrist-worn wearable device (Fitbit Inspire 3) after assignment, and at the same time, they will download the physical activity management application software, Recaval (Saplim, Inc.) to their smartphones. The patient's physical activity data and pulse rate data obtained from the wearable device will be transmitted in real time via the app to the tablet device of the physical therapist in charge of the research facility. Patients will be instructed to wear the wearable device when not bathing or charging the device. In addition, patients will be instructed to enter their daily blood pressure and subjective symptom self-records on the app, which will also be monitored daily by the physical therapist.
At the beginning of the intervention and every two weeks thereafter, the physical therapist provides a summary report of daily vital sign data to the patient on the app, along with educational comments and praise for each patient's physical activity and activity pulse rate goals and achievement of those goals.
Interventions/Control_2
Control group (usual care)
The patients in the control groups will receive usual care, including patient education, medications, outpatient visits, and laboratory tests at the time of discharge from the hospital, within the scope of usual medical care. However, if patients wish to participate in outpatient cardiac rehabilitation during the observation period, their wishes will be respected and they may freely choose to participate in outpatient cardiac rehabilitation after consultation with a physician. In this case, the patient will not be excluded from the study, but will continue to be observed under the conditions of "intervention + outpatient cardiac rehabilitation" for the intervention group and "usual care + outpatient cardiac rehabilitation" for the control group.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Age 18 years or older at the time of consent
2) Patients who developed ACS and underwent percutaneous coronary angioplasty and inpatient cardiac rehabilitation
3) Patients who have difficulty participating in outpatient cardiac rehabilitation after discharge from the hospital
4) Patients who have a smartphone
5) Patients who agreed to participate in this study
Key exclusion criteria
1) Patients who are not independent in daily living
2) Patients with unstable angina pectoris
3) Patients with uncontrolled arrhythmia causing hemodynamic abnormalities
4) Patients with severe valvular heart disease
5) Patients with uncontrolled diabetes mellitus
6) Patients with other diseases that contraindicate the use of exercise therapy
7) Patients on dialysis
8) Patients with complications of other acute diseases or indications for surgical treatment
9) Patients with dementia
10) Patients who have difficulty in receiving regular outpatient visits at the facility after discharge from the hospital
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Toshimi |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5552
satot-pt@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Toshimi |
| Middle name | |
| Last name | Sato |
Organization
Fukushima Medical University
Division name
Department of Physical Therapy
Zip code
960-8516
Address
10-6, Sakaemachi, Fukushima City, Japan
TEL
024-581-5552
Homepage URL
satot-pt@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima Medical University
Address
1 Hikariga-oka, Fukushima City 960-1295, JAPAN
Tel
+81-24-547-1111
rs@fmu.ac.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
総合南東北病院（福島県）、太田西ノ内病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061110
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