Chronic Wounds and Blood Circulation Detection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intervention 1: Mixed exercise program, Intervention 2: High-intensity rowing exercise, Intervention 3: Vibration exercise.
- Who it may be relevant to
- Registry conditions: Aging, Walking, Difficulty, Chronic Limb-Threatening Ischemia, Chronic Disease. Basic parameters: 20 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Constructing a Holistic Care New Model for Chronic Wounds and Blood Circulation Detection to Enhance Home Care Quality
Overview
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.
Interventions
- 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. - 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 - 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
Primary outcome measures
- Lower limb blood perfusion [Time frame: Baseline and after 12 weeks of intervention]
Secondary outcome measures (3)
- Functional performance (Six-Minute Walk Test) [Time frame: Baseline and after 12 weeks of intervention]
- Functional performance (30-Second Sit-to-Stand Test) [Time frame: Baseline and after 12 weeks of intervention]
- Functional performance (10-Meter Walk Test) [Time frame: Baseline and after 12 weeks of intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- National Center for Geriatrics and Welfare Research, National Health Research Institutes — Taipei
Identifiers
NCT: NCT07330635 · EC1130704-E