UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063163 |
|---|---|
| Receipt number | R000072293 |
| Scientific Title | Acceptability and feasibility of a cardiovascular disease prevention programme for truck drivers: a feasibility study in small and medium-sized trucking companies |
| Date of disclosure of the study information | 2026/10/03 |
| Last modified on | 2026/10/03 17:57:47 |
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Basic information
Public title
Acceptability and feasibility of a cardiovascular disease prevention programme for truck drivers: a feasibility study in small and medium-sized trucking companies
Acronym
TRUCK-FS
Scientific Title
Acceptability and feasibility of a cardiovascular disease prevention programme for truck drivers: a feasibility study in small and medium-sized trucking companies
Scientific Title:Acronym
TRUCK-FS
Region
| Japan |
Condition
Condition
Hypertension (prevention of cardiovascular disease)
Cardiometabolic risk factors in occupational truck drivers
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the acceptability and feasibility of a cardiovascular disease prevention programme consisting of steering-wheel-based isometric handgrip exercise and home blood pressure self-monitoring among active truck drivers employed by small and medium-sized trucking companies, and to determine whether a full-scale intervention trial is warranted.
This is a conditional two-stage design: Stage 2 (a 12-week single-arm pilot intervention) is conducted only if the results of Stage 1 (an acceptability survey of drivers and interviews with company managers) meet predefined progression criteria.
Basic objectives2
Others
Basic objectives -Others
Assessment of acceptability and feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[Stage 1 (1) Acceptability survey of drivers]
- Programme acceptability score (sum and distribution of 5-point ratings for each programme component)
- Willingness to participate in the pilot intervention (proportion answering "definitely want to take part" or "would take part if conditions are met")
[Stage 1 (2) Interviews with company managers]
- Willingness to pay for a health management service (acceptance/non-acceptance of presented annual amounts per employee, and maximum acceptable amount)
- Criteria for adopting a prevention programme (content analysis of verbatim transcripts of semi-structured interviews)
[Stage 2 Pilot intervention]
- Participation rate (proportion of those willing to participate who actually started the intervention)
- Retention rate (proportion completing the 12-week (84-day) intervention period)
- Acceptability score (experienced acceptability, by post-intervention questionnaire)
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Participants perform steering-wheel isometric handgrip exercise (about 30% of maximal grip strength, 2 min hold and 1 min rest, 4 sets alternating hands, about 12-15 min per session) about 3 times per week while parked or on break, and measure blood pressure with a wrist monitor once daily after waking, for 12 weeks (84 days). Volunteers may also wear a smart ring to record sleep and activity. A web questionnaire on acceptability and willingness to participate (Stage 1) precedes the intervention.
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
(1) Truck drivers employed by participating companies whose main duty is driving (driving on about 10 or more days in the past month). (2) Aged 20 years or older. (3) Written (including electronic) informed consent. (4) For Stage 2, additionally: willing to participate, passed safety screening (physician approval required for those aged 65 or older and those with a history of heart disease, severe hypertension, or cerebrovascular disease), and reachable for on-site or remote follow-up. (5) For employer interviews: company representatives or health management officers who give consent.
Key exclusion criteria
(1) Not currently driving due to long-term leave (e.g., 3 months or longer). (2) Judged unable to participate due to severe psychiatric disorder or cognitive impairment. (3) For Stage 2: exercise prohibited or restricted by a physician, or required physician approval not obtained.
Target sample size
103
Research contact person
Name of lead principal investigator
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
TEL
0476-20-7746
shinta.t@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Shinta |
| Middle name | |
| Last name | Takeuchi |
Organization
International University of Health and Welfare
Division name
Department of Physical Therapy, School of Health Sciences at Narita
Zip code
286-8686
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
TEL
0476-20-7746
Homepage URL
shinta.t@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Aioi Nissay Dowa Insurance Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of International University of Health and Welfare, Chiba Area
Address
4-3 Kozunomori, Narita, Chiba 286-8686, Japan
Tel
0476-20-7708
rinri_md@iuhw.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
| 2026 | Year | 10 | Month | 03 | 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
| 2026 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2028 | 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
| 2026 | Year | 10 | Month | 03 | Day |
Last modified on
| 2026 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072293
