Chronic Wounds and Blood Circulation Detection

December 29, 2025 updated by: National Health Research Institutes, Taiwan

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

425

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Center for Geriatrics and Welfare Research, National Health Research Institutes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Behavioral: 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.
Other Names:
  • Mixed exercise program
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
Other Names:
  • Lower limb rowing exercise program
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
Other Names:
  • Vibration exercise program
Experimental: 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).
Behavioral: 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.
Other Names:
  • Mixed exercise program
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
Other Names:
  • Lower limb rowing exercise program
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
Other Names:
  • Vibration exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and after 12 weeks of intervention
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.
Baseline and after 12 weeks of intervention
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.
Baseline and after 12 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2024

Primary Completion (Estimated)

September 4, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC1130704-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data (IPD) due to participant privacy protection and institutional policy restrictions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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