NCT07330635

Chronic Wounds and Blood Circulation Detection

Constructing a Holistic Care New Model for Chronic Wounds and Blood Circulation Detection to Enhance Home Care Quality

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 425 (estimated)
• Sponsor: National Health Research Institutes, Taiwan · Academic / Other
• Sex: All
• Age: 20 Years – 95 Years
• Healthy volunteers: Accepted

Summary

Lower limb circulatory insufficiency and the associated chronic wounds are common health problems among the elderly. These issues not only affect the individual's mobility and quality of life but also potentially increase medical costs and caregiving expenses. Traditional treatment methods often employ medications to enhance blood circulation, but these clinical approaches have limited effectiveness and induce the risk of side effects. Utilizing exercise as an intervention strategy can help improve lower limb blood circulation in the elderly while reducing the side effects associated with medications. However, due to physical frailty, elderly individuals often cannot participate in high-intensity exercises to improve their circulatory performance. Therefore, this study will develop a lower limb circulation enhancement exercise system to improve the circulatory performance in individuals with poor lower limb circulation. It will compare the effects of lower limb circulation enhancement exercise, vibration exercise, and mixed exercise on improving blood circulation and functional performance in the elderly or individuals with poor lower limb circulation. Participants will be randomly assigned into three groups: the lower limb circulation enhancement exercise group, the vibration exercise group, and the mixed exercise group. In addition, a separate group of young adults (control group) will serve as a reference for baseline comparisons. Initially, all participants will undergo a one-time exercise test, followed by a 12-week intervention. The lower limb circulation enhancement exercise group will perform a 30-minute leg press rowing exercise three times a week, while the vibration exercise group will engage in vibration exercise at the same frequency, and the mixed exercise group will perform group-based mixed exercise training at the same frequency. The young adult control group will not receive any intervention but will undergo the same assessments. Outcome evaluations before and after the intervention include lower limb blood perfusion monitoring, pain scales, and functional performance assessments.

Conditions

• Aging
• Walking, Difficulty
• Chronic Limb-Threatening Ischemia
• Chronic Disease

Interventions

Type	Name	Description
BEHAVIORAL	Intervention 1: Mixed exercise program	A 12-week, group-based mixed exercise program focusing on lower limb strengthening, balance, and aerobic training (3 sessions per week, 30 minutes per session). Exercise intensity will be adjusted based on individual fitness and circulation levels.
BEHAVIORAL	Intervention 2: High-intensity rowing exercise	A 12-week, high-intensity lower limb rowing exercise program (3 sessions per week, 30 minutes per session), with individualized intensity adjustments based on each participant's baseline
BEHAVIORAL	Intervention 3: Vibration exercise	A 12-week, vibration exercise program (3 sessions per week, 30 minutes per session), with individualized intensity adjustments based on each participant's baseline

Timeline

• Start date: 2024-09-04
• Primary completion: 2027-09-04
• Completion: 2027-12-31
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: Taiwan