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Chronic Wounds and Blood Circulation Detection

N

National Health Research Institutes, Taiwan

Status

Enrolling

Conditions

Aging
Chronic Disease
Walking, Difficulty
Chronic Limb-Threatening Ischemia

Treatments

Behavioral: Intervention 2: High-intensity rowing exercise
Behavioral: Intervention 1: Mixed exercise program
Behavioral: Intervention 3: Vibration exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT07330635
EC1130704-E

Details and patient eligibility

About

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.

Enrollment

425 estimated patients

Sex

All

Ages

20 to 95 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

425 participants in 3 patient groups

Young Adults (Reference Control)
No Intervention group
Description:
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.
Older adults (Exercise intervention)
Experimental group
Description:
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.
Treatment:
Behavioral: Intervention 3: Vibration exercise
Behavioral: Intervention 1: Mixed exercise program
Behavioral: Intervention 2: High-intensity rowing exercise
Older adults with chronic disease (Exercise intervention)
Experimental group
Description:
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).
Treatment:
Behavioral: Intervention 3: Vibration exercise
Behavioral: Intervention 1: Mixed exercise program
Behavioral: Intervention 2: High-intensity rowing exercise

Trial contacts and locations

1

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Central trial contact

Po-Jung Chen, Ph.D.; Chueh-Ho Lin, Ph.D.

Data sourced from clinicaltrials.gov

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