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Wearable device-enhanced Outpatient cardiac Rehabilitation for improving Quality of life and productivity in Heart Disease

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 - WORQ-HD trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057539
Enrollment
40
Registered
2025-04-07
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Disease

Interventions

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 dur
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
s condition. Routine medical care, including consultations and therapeutic guidance such as nutritional counseling, will continue. In both the intervention and control groups, outpatient cardiac re
s condition based on cardiopulmonary exercise testing, t

Sponsors

Shijonawate Gakuen University
Lead Sponsor
Ide Heart Clinic, Kino Clinic
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactKazufumi Kitagaki

Shijonawate Gakuen University Faculty of Rehabilitation

k-kitagaki@un.shijonawate-gakuen.ac.jp072-863-5043

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026