Chronic Wounds and Blood Circulation Detection

NCT07330635 | Recruiting

• 1 other identifier: EC1130704-E
• Study Type: interventional
• Target: 425
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Poor Lower Limb Circulation; Older Adults; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• Lower limb blood perfusion

  Lower limb blood perfusion will be assessed using Laser Doppler Flowmetry (LDF) and Laser Speckle Contrast Imaging (LSCI). For LSCI, measurements will be performed at the plantar surface beneath the hallux. The protocol includes a baseline recording period, transient arterial occlusion using an ankle cuff, and post-occlusion monitoring to capture recovery and reactive changes. Skin perfusion pressure (SPP) will be derived from the LSCI signal inflection point following cuff release, expressed in millimeters of mercury (mmHg).

  Baseline and after 12 weeks of intervention

Secondary Outcomes (3)

• Functional performance (Six-Minute Walk Test)

  Baseline and after 12 weeks of intervention

• Functional performance (30-Second Sit-to-Stand Test)

  Baseline and after 12 weeks of intervention

• Functional performance (10-Meter Walk Test)

  Baseline and after 12 weeks of intervention

Study Arms (3)

Young Adults (Reference Control)

NO INTERVENTION

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

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.

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

Older adults with chronic disease (Exercise intervention)

EXPERIMENTAL

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).

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

Interventions

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

Also known as: Lower limb rowing exercise program

Older adults (Exercise intervention); Older adults with chronic disease (Exercise intervention)

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

Also known as: Vibration exercise program

Older adults (Exercise intervention); Older adults with chronic disease (Exercise intervention)

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.

Also known as: Mixed exercise program

Older adults (Exercise intervention); Older adults with chronic disease (Exercise intervention)

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Recent acute lower limb injury resulting in tissue exudation, swelling, or other conditions that prevent safe participation in the assessment or intervention procedures.

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

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

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Mobility Limitation; Chronic Limb-Threatening Ischemia; Chronic Disease

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Disease Attributes; Pathologic Processes; Ischemia

Central Study Contacts

Po-Jung Chen, Ph.D.

CONTACT

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

Chueh-Ho Lin, Ph.D.

CONTACT

+886-5-632-5080; chueh.ho@nhri.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 9, 2026
• Study Start: September 4, 2024
• Primary Completion (Estimated): September 4, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 9, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)