Tokyo, Oct. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063163) titled 'Acceptability and feasibility of a cardiovascular disease prevention programme for truck drivers: a feasibility study in small and medium-sized trucking companies' on Oct. 3.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - International University of Health and Welfare

Condition: Condition - Hypertension (prevention of cardiovascular disease) Cardiometabolic risk factors in occupational truck drivers Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 103

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072293

Disclaimer: Curated by HT Syndication.