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NCT Number: NCT07330635

Chronic Wounds and Blood Circulation Detection

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.

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Key information

Conditions

Aging Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Chronic Limb-Threatening Ischemia Disease Attributes Ischemia Mobility Limitation Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases Walking, Difficulty

Age range

20 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Taipei, Taiwan

Location status: Recruiting

Location contact

Po-Jung Chen, Ph.D.

CONTACT

[email protected]

+886-5-632-5080 ext. 17

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Mixed exercise program

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

Other names: Lower limb rowing exercise program

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

Other names: Vibration exercise program

Primary outcomes

  1. Lower limb blood perfusion

    Time frame: Baseline and after 12 weeks of intervention

    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).

Secondary outcomes

  1. Functional performance (Six-Minute Walk Test)

    Time frame: Baseline and after 12 weeks of intervention

    Walking distance covered in six minutes on a flat surface, used to assess cardiovascular endurance and functional walking capacity.

  2. Functional performance (30-Second Sit-to-Stand Test)

    Time frame: Baseline and after 12 weeks of intervention

    Number of full sit-to-stand repetitions completed in 30 seconds from a standard chair without using the arms, used to evaluate lower limb strength and functional mobility.

  3. Functional performance (10-Meter Walk Test)

    Time frame: Baseline and after 12 weeks of intervention

    Walking speed over a 10-meter distance at a comfortable pace, measured to assess gait performance and walking efficiency.

Study contacts

Contact information is provided by the study sponsor or research team.

Chueh-Ho Lin, Ph.D.

CONTACT

[email protected]

+886-5-632-5080 ext. 15

Po-Jung Chen, Ph.D.

CONTACT

[email protected]

+886-5-632-5080 ext. 17

Sponsors and collaborators

Lead sponsor

National Health Research Institutes, Taiwan

Other

Registry information

Official study title

Constructing a Holistic Care New Model for Chronic Wounds and Blood Circulation Detection to Enhance Home Care Quality

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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