Aging, Chronic Disease, Chronic Limb-Threatening Ischemia, Walking, Difficulty
Conditions
Keywords
Poor Lower Limb Circulation, Older Adults, Chronic Disease
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.
Interventions
BEHAVIORALIntervention 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.
BEHAVIORALIntervention 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
BEHAVIORALIntervention 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
Sponsors
National Health Research Institutes, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower limb blood perfusion | 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
| Measure | Time frame | Description |
|---|---|---|
| Functional performance (Six-Minute Walk Test) | 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. |
| Functional performance (30-Second Sit-to-Stand Test) | 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. |
| Functional performance (10-Meter Walk Test) | 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. |
Countries
Taiwan
Contacts
Primary ContactPo-Jung Chen, Ph.D.
Backup ContactChueh-Ho Lin, Ph.D.
Outcome results
None listed