RecruitingNot Applicable

Chronic Wounds and Blood Circulation Detection

Taiwan425 participantsStarted 2024-09-04

Plain-language 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.

Who can participate

Age range

20 Years – 95 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: General criteria (applied to all participants): Willingness to participate in this study and comply with all study procedures. Able to perform basic physical activity and complete lower limb circulatory and functional assessments. Normal cognitive function sufficient to understand instructions and provide informed consent. Group-specific criteria: Young Adults (Control Group):Aged 20-40 years.No known chronic diseases or peripheral circulatory disorders.Considered healthy volunteers. Older Adults (Healthy Elderly Group):Aged 65-95 years.No major chronic diseases affecting lower limb circulation. Older Adults with Chronic Disease (Impaired Circulation Group):Aged 65-95 years.Diagnosed with one or more conditions known to impair peripheral circulation, including but not limited to peripheral arterial disease (e.g., atherosclerosis, thromboangiitis obliterans), chronic venous insufficiency (e.g., varicose veins), diabetes mellitus, hypertension, or hyperlipidemia. Exclusion Criteria: Recent acute lower limb injury resulting in tissue exudation, swelling, or other conditions that prevent safe participation in the assessment or intervention procedures.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lower limb blood perfusion

Timeframe: Baseline and after 12 weeks of intervention

Trial details

NCT IDNCT07330635

SponsorNational Health Research Institutes, Taiwan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-04

Contact for this trial

Po-Jung Chen, Ph.D.

+886-5-632-5080 pojungchen@nhri.edu.tw

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