Chronic Wounds and Blood Circulation Detection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-95
SponsorNational Health Research Institutes, Taiwan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Intervention 1: Mixed exercise program
BehavioralA 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.
Intervention 2: High-intensity rowing exercise
BehavioralA 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
Intervention 3: Vibration exercise
BehavioralA 12-week, vibration exercise program (3 sessions per week, 30 minutes per session), with individualized intensity adjustments based on each participant's baseline
Treatment groups
425 Participants
are divided into 3 treatment groupsGroup A: Young Adults (Reference Control)No intervention 0 interventions
Group B: Older adults (Exercise intervention)Experimental treatment 3 interventions
Group C: Older adults with chronic disease (Exercise intervention)Experimental treatment 3 interventions
Trial outcomes
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).
Time frame
Baseline and after 12 weeks of interventionSecondary outcomes
1
Functional performance (Six-Minute Walk Test)
Walking distance covered in six minutes on a flat surface, used to assess cardiovascular endurance and functional walking capacity.
Time frame
Baseline and after 12 weeks of intervention2
Functional performance (30-Second Sit-to-Stand Test)
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.
Time frame
Baseline and after 12 weeks of intervention3
Functional performance (10-Meter Walk Test)
Walking speed over a 10-meter distance at a comfortable pace, measured to assess gait performance and walking efficiency.
Time frame
Baseline and after 12 weeks of interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov