UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057539 |
|---|---|
| Receipt number | R000065736 |
| Scientific Title | Impact of Combining Wearable Devices with Outpatient Cardiac Rehabilitation on Work Productivity and Quality of Life in Employed Patients with Heart Disease: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/04/07 |
| Last modified on | 2025/10/07 09:17:30 |
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Basic information
Public title
Wearable device-enhanced Outpatient cardiac Rehabilitation for improving Quality of life and productivity in Heart Disease
Acronym
WORQ-HD trial
Scientific Title
Impact of Combining Wearable Devices with Outpatient Cardiac Rehabilitation on Work Productivity and Quality of Life in Employed Patients with Heart Disease: A Randomized Controlled Trial
Scientific Title:Acronym
WORQ-HD trial
Region
| Japan |
Condition
Condition
Heart Disease
Classification by specialty
| Cardiology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether remote monitoring of physical activity at work using wearable devices contributes to maintaining work productivity and improving health-related quality of life in patients with heart disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is presenteeism, which will be assessed using the Japanese version of the Work Limitations Questionnaire.
The assessment will be conducted at baseline and at 12 weeks to evaluate changes over time.
Key secondary outcomes
Health-related quality of life will be assessed using the EQ-5D-5L.
Exercise tolerance will be evaluated based on peak oxygen uptake and anaerobic threshold obtained from cardiopulmonary exercise testing.
Physical function will be assessed through isometric knee extension strength using a muscle strength measurement device, and by evaluating balance, gait speed, and the five-time sit-to-stand test using the Short Physical Performance Battery (SPPB).
Adherence will be assessed by the number of outpatient visits and the number of web-based guidance sessions during the study period.
Cardiac disease control will be evaluated by measuring NT-proBNP levels in blood samples.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
In the intervention group, patients will be provided with a wearable device (Fitbit) , along with instructions on how to use it.
Patients will be instructed to wear the Fitbit at all times except during sleep and bathing. They will also be advised to charge the device once a week during sleep.
Healthcare providers will contact patients once a week via the Fitbit application (outside of outpatient visits).
The communication will focus on confirming the prescribed exercise intensity and the actual activity intensity during work.
If patients are unable to use the chat function for any reason, contact will be made by phone.
In both the intervention and control groups, outpatient cardiac rehabilitation will be conducted once a week in accordance with established guidelines. Exercise prescriptions will be tailored to each patient's condition based on cardiopulmonary exercise testing, targeting either the anaerobic threshold or 40-60% of peak oxygen uptake (VO2peak), or an intensity corresponding to 40-60% of heart rate reserve (HRR) using the Karvonen method. Each session will last 30 to 60 minutes. Home-based exercise will be recommended three times per week at the same intensity as the outpatient sessions. Patient education - including guidance on body weight, blood pressure, and diet - will also follow the guidelines and be adapted as necessary based on the patient's condition.
Interventions/Control_2
Routine medical care, including consultations and therapeutic guidance such as nutritional counseling, will continue.
In both the intervention and control groups, outpatient cardiac rehabilitation will be conducted once a week in accordance with established guidelines. Exercise prescriptions will be tailored to each patient's condition based on cardiopulmonary exercise testing, targeting either the anaerobic threshold or 40-60% of peak oxygen uptake (VO2peak), or an intensity corresponding to 40-60% of heart rate reserve (HRR) using the Karvonen method. Each session will last 30 to 60 minutes. Home-based exercise will be recommended three times per week at the same intensity as the outpatient sessions. Patient education - including guidance on body weight, blood pressure, and diet - will also follow the guidelines and be adapted as necessary based on the patient's condition.
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) Patients with heart disease who are eligible for cardiac rehabilitation and are attending outpatient clinics at the collaborating institutions
2) Patients who are employed at the time of obtaining informed consent
3) Patients aged 18 years or older at the time of obtaining informed consent
Key exclusion criteria
1) Patients who do not provide informed consent
2) Patients who have difficulty operating a smartphone
3) Patients who are restricted from working by their attending physician or occupational physician
4) Patients with contraindications to cardiac rehabilitation
5) Patients with a silicone allergy
6) Patients with implanted cardiac electrical devices
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazufumi |
| Middle name | |
| Last name | Kitagaki |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Houjou Daito, Osaka
TEL
072-863-5043
k-kitagaki@un.shijonawate-gakuen.ac.jp
Public contact
Name of contact person
| 1st name | Kazufumi |
| Middle name | |
| Last name | Kitagaki |
Organization
Shijonawate Gakuen University
Division name
Faculty of Rehabilitation
Zip code
574-0011
Address
5-11-10 Houjou Daito, Osaka
TEL
072-863-5043
Homepage URL
k-kitagaki@un.shijonawate-gakuen.ac.jp
Sponsor or person
Institute
Shijonawate Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ide Heart Clinic, Kino Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shijonawate Gakuen University
Address
5-11-10 Houjou Daito, Osaka
Tel
072-863-5043
a-matsugi@un.shijonawate-gakuen.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
いでハートクリニック（大阪府）、きのうクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 07 | 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
| 2025 | Year | 04 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | 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
| 2025 | Year | 04 | Month | 07 | Day |
Last modified on
| 2025 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065736
