Chronic Wounds and Blood Circulation Detection

Sponsor
National Health Research Institutes, Taiwan
Study ID
NCT07330635
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
20 Years - 95 Years
Healthy Volunteers
Accepted

Interventions

  • Intervention 1: Mixed exercise program — BEHAVIORAL
    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.
  • Intervention 2: High-intensity rowing exercise — BEHAVIORAL
    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
  • Intervention 3: Vibration exercise — BEHAVIORAL
    A 12-week, vibration exercise program (3 sessions per week, 30 minutes per session), with individualized intensity adjustments based on each participant's baseline

Study Details

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.

Key Dates

First listed
Jan 9, 2026
Start date
Sep 4, 2024
Status verified
Sep 2025
Primary completion
Sep 4, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
425 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Young Adults (Reference Control)
    Healthy young adults aged 20-35 years serving as the reference control group. Participants will not receive any intervention but will undergo the same baseline and follow-up assessments of lower limb circulation and functional performance.
  • Experimental: Older adults (Exercise intervention)
    Older adults aged 65 years. Participants will engage in a 12-week, group-based exercise program (3 sessions per week, 30 minutes per session) focusing on lower limb strengthening, balance, and aerobic training.
  • Experimental: Older adults with chronic disease (Exercise intervention)
    Older adults aged 65 years and above with chronic disease. Participants will engage in a 12-week exercise program (3 sessions per week, 30 minutes per session).

Primary Outcome Measure

Lower limb blood perfusion [ Time Frame: Baseline and after 12 weeks of intervention ]

Central Contacts

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