Chronic Wounds and Blood Circulation Detection

NCT ID: NCT07330635

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-04

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aging Walking, Difficulty Chronic Limb-Threatening Ischemia Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a three-arm parallel interventional study comparing lower limb circulation and functional performance across young adults, older adults, and older adults with poor peripheral circulation. A 12-week group-based mixed exercise intervention is applied to the older adults and circulation-deficient groups, while the young adult group serves as a reference control without intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Intervention 1: Mixed exercise program

Intervention Type 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

Intervention Type 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

Intervention Type 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

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).

Group Type EXPERIMENTAL

Intervention 1: Mixed exercise program

Intervention Type 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

Intervention Type 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

Intervention Type 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

Interventions

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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.

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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Mixed exercise program Lower limb rowing exercise program Vibration exercise program

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Health Research Institutes, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Center for Geriatrics and Welfare Research, National Health Research Institutes

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Po-Jung Chen, Ph.D.

Role: CONTACT

+886-5-632-5080 ext. 17

Chueh-Ho Lin, Ph.D.

Role: CONTACT

+886-5-632-5080 ext. 15

Facility Contacts

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Po-Jung Chen, Ph.D.

Role: primary

+886-5-632-5080 ext. 17

Other Identifiers

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EC1130704-E

Identifier Type: -

Identifier Source: org_study_id

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