UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055334 |
|---|---|
| Receipt number | R000063214 |
| Scientific Title | Hypothesis generating study to assess 3-month personal health record (Fitbit) retention and exercise tolerance in outpatients undergoing outpatient cardiac rehabilitation after transcatheter aortic valve replacement |
| Date of disclosure of the study information | 2024/08/28 |
| Last modified on | 2025/02/04 11:59:18 |
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Basic information
Public title
Study to assess 3-month Fitbit retention and exercise tolerance in outpatients undergoing outpatient cardiac rehabilitation after transcatheter aortic valve replacement
Acronym
Study to assess 3-month Fitbit retention and exercise tolerance in outpatients undergoing outpatient cardiac rehabilitation after transcatheter aortic valve replacement
Scientific Title
Hypothesis generating study to assess 3-month personal health record (Fitbit) retention and exercise tolerance in outpatients undergoing outpatient cardiac rehabilitation after transcatheter aortic valve replacement
Scientific Title:Acronym
Hypothesis generating study to assess 3-month personal health record (Fitbit) retention and exercise tolerance in outpatients undergoing outpatient cardiac rehabilitation after transcatheter aortic valve replacement
Region
| Japan |
Condition
Condition
severe aortic valve stenosis
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A single-center, single-arm, hypothesis-generating intervention study was designed to determine the primary outcome of 3-month retention of a wristwatch personal health record (PHR) (hereafter referred to as Fitbit) in patients undergoing transcatheter aortic valve implantation (TAVI). A single-center, single-arm, hypothesis-generating intervention study was designed with a primary outcome of retention of wristwatch personal health record (PHR) (henceforth Fitbit) use. Secondary outcomes will be the representative values of heart rate and step rate measured by Fitbit, as well as the 6-minute walk test, which will be evaluated over time. This study focuses on confirming the acceptability of Fitbit in the TAVI patient population for the very elderly and frail.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of Fitbit wearers who continue to wear the Fitbit at 3 months after TAVI
Key secondary outcomes
1) The following items at the beginning of the intervention and 3 months later
6-minute walking distance over time
2) Representative values (mean, median, mode, maximum, and minimum) of number of steps and heart rate measured by Fitbit
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Patients indicated for TAVI will be fitted with a wearable device (Fitbit) at the start of their first post-TAVI exercise rehearsal.
The primary outcome will be the 3-month retention rate of wearing the Fitbit, with Day 0 as the initial rehabilitation period.
The target number of patients is 30.
The number of interventions will be the 6-minute walk test at the beginning of the initial exercise rehearsal and at the end of the 3-month exercise rehearsal.
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
Eligibility
Age-lower limit
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are eligible
1) Patients who have undergone TAVI in severe aortic stenosis
2) Patients aged 60 years or older at the time of consent (regardless of gender)
3) Research subjects who have given a full explanation of their participation in this study and have given their free written consent.
4) Patients scheduled for outpatient cardiac rehabilitation
Key exclusion criteria
Patients who violate any of the following conditions will not be included in this study
1) Patients who do not have a reliable Internet connection at home, do not have a smartphone, or are otherwise unable to establish a Fitbit use environment.
2) Patients for whom exercise therapy is contraindicated
3) Patients who have difficulty performing the exercise tolerance test due to other diseases or pain
4) Patients who have difficulty operating the Fitbit due to visual or hearing impairment
5) Patients who have experienced hypotension, fatal arrhythmia, or other adverse events during cardiac rehabilitation, exercise stress tests, or exercise therapy.
5) Patients who have experienced hypotension, fatal arrhythmia or other adverse events during cardiac rehabilitation, exercise testing or exercise therapy
6) Patients scheduled to undergo inpatient cardiac rehabilitation for more than 4 weeks
7) Patients who have participated in other clinical trials or clinical studies involving interventions within the past 12 weeks of obtaining consent
8) Patients who the investigator determines to be incapable of correctly understanding the significance of the research and complying with the compliance requirements due to dementia, mental illness, etc.
9) Other patients who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Saito |
Organization
Shonan Kamakura General Hospital
Division name
Cardiac Center
Zip code
247-8533
Address
1370-1 Okamoto,Kamakura-City
TEL
0467-46-1717
transradial@kamakuraheart.org
Public contact
Name of contact person
| 1st name | Futoshi |
| Middle name | |
| Last name | Yamanaka |
Organization
Shonan Kamakura General Hospital
Division name
Cardiac Center
Zip code
247-8533
Address
1370-1 Okamoto,Kamakura-City
TEL
0467-46-1717
Homepage URL
futoshi.yamanaka@gmail.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
The Tokushukai Group Ethics Commitee
Address
15F, Tokyo-Do Chiyoda Bldg. 1-3-1 Kudan-Minami, Chiyoda-ku, Tokyo, Japan
Tel
0332634801
crb_itoku@shonankamakura.or.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063214
