UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046777 |
|---|---|
| Receipt number | R000053362 |
| Scientific Title | A Pilot Study of Unsupervised Home-based Cardiac Rehabilitation Using a Wearable Device and Smartphone Application |
| Date of disclosure of the study information | 2022/01/31 |
| Last modified on | 2023/09/19 22:23:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Pilot Study of Unsupervised Home-based Cardiac Rehabilitation Using a Wearable Device and Smartphone Application
Acronym
A Pilot Study of Unsupervised Home-based Cardiac Rehabilitation with Gamification (GamiHeart pilot study)
Scientific Title
A Pilot Study of Unsupervised Home-based Cardiac Rehabilitation Using a Wearable Device and Smartphone Application
Scientific Title:Acronym
A Pilot Study of Unsupervised Home-based Cardiac Rehabilitation with Gamification (GamiHeart pilot study)
Region
| Japan |
Condition
Condition
Acute Cardiac Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether a wearable device (smartwatch) and a smartphone application with a minimum of gamification elements can be safely used for unsupervised home-based cardiac rehabilitation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency with which patients appropriately performed unsupervised home-based cardiac rehabilitation during the study period
Key secondary outcomes
1. Change in body mass index, peak VO2 and anaerobic threshold in cardiopulmonary exercise test, LDL-cholesterol, HDL-cholesterol, triglycerides, and HbA1c in blood test
2. Change in Health-Related Quality of Life questionnaire (36-Item Short Form Survey, SF-36), depressive and anxiety symptoms questionnaire (Hospital Anxiety and Depression Scale, HADS)
3. Change in the visual analogue scale (0-100, with higher scores indicating greater discomfort with exercise therapy)
(As for 1-3, changes are shown before and after the intervention period [4-5 weeks]).
4. Correlation between the results of the Type D personality questionnaire (Type D Scale-14, DS-14) administered before intervention and the primary outcome.
5. Frequency of new complications during the study period (4-5 weeks)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Wearing a smartwatch and using a smartphone application during the intervention period (4-5 weeks)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients hospitalized for acute coronary syndrome and undergoing percutaneous coronary intervention who are 20 years of age or older and can perform outdoor activities of daily living without assistance
Key exclusion criteria
1. Patients who are unable to give their written consent
2. Patients who are unable to fill out the questionnaire on their own
3. Patients who are walking with a cane or cannot walk to the hospital by themselves
4. Patients with other serious diseases (cancer, collagen disease, etc.) who are judged by the physician in charge to be inappropriate for this study
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Akashi |
Organization
St. Marianna University Hospital
Division name
Cardiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
044-977-8111
yoakashi-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Kaihara |
Organization
St. Marianna University Hospital
Division name
Cardiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL
044-977-8111
Homepage URL
m03014tk@jichi.ac.jp
Sponsor or person
Institute
St. Marianna University Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University Hospital
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
St. Marianna University Hospital
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
Tel
044-977-8111
junkanki@marianna-u.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 31 | 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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 01 | Month | 30 | Day |
Last modified on
| 2023 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053362
