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临床试验/NCT07262203
NCT07262203已完成不适用

Effectiveness of Diabetic Foot Exercises on Peripheral Vascular Status Among Patients With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

Universitas Muhammadiyah Surakarta2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
44
试验地点
2
主要终点
Change in Ankle-Brachial Index (ABI)

研究概览

简要总结

This randomized controlled trial aims to evaluate the effectiveness of diabetic foot exercises on peripheral vascular status among patients with type 2 diabetes mellitus. Peripheral artery disease is a common complication of diabetes and contributes to reduced mobility and increased risk of ulcers, ischemia, and amputation. Early identification and non-pharmacological interventions such as structured lower extremity exercises may help improve peripheral circulation.

In this study, 44 adults with type 2 diabetes mellitus who met the inclusion criteria were randomly assigned to either an intervention group receiving diabetic foot exercises or a control group performing regular physical activity of similar frequency and duration. The exercise protocol used in the intervention group was adapted from the Joslin Diabetes Center and included balance, strengthening, and ankle-foot mobility exercises. The intervention lasted for 3 months.

Peripheral vascular status was assessed using the ankle-brachial index (ABI) measured with a Doppler device at baseline and after 3 months. The study found that participants in the intervention group demonstrated a significant improvement in ABI values compared with the control group, indicating enhanced lower-limb blood flow.

This trial provides evidence that diabetic foot exercises are a simple, low-cost, and feasible intervention to improve peripheral vascular circulation in patients with type 2 diabetes mellitus, particularly in settings with limited resources.

详细描述

This randomized controlled trial was conducted to determine the effectiveness of diabetic foot exercises in improving peripheral vascular status among patients with type 2 diabetes mellitus (T2DM). Diabetes mellitus is a chronic metabolic disorder associated with multiple vascular complications, including peripheral artery disease (PAD). PAD in diabetic patients is frequently asymptomatic during the early stages, yet it substantially increases the risk of ischemia, ulceration, and lower-limb amputation. Regular physical activity and targeted exercises have been shown to improve circulation and functional capacity. However, evidence regarding the effects of specific diabetic foot exercise programs on peripheral vascular status remains limited in Indonesia.

A total of 44 participants with T2DM were recruited from PERSADIA at Dr. Moewardi Hospital, Central Java, Indonesia. Participants were randomly assigned to either the treatment group (n = 22) or control group (n = 22) using a card-shuffle randomization method. Inclusion criteria included age above 50 years and a diagnosis of T2DM for at least 5 years. Exclusion criteria included inability to walk independently, lower extremity pain, severe arthritis, neurological or cardiovascular disorders, limited physical activity, or cognitive impairment. All participants provided written informed consent before enrollment.

The intervention consisted of a structured diabetic foot exercise program adapted from the Joslin Diabetes Center, involving quadriceps strengthening, balance exercises, ankle and foot mobility movements, and kicking exercises. Participants in the intervention group were instructed to perform the exercises daily for approximately 30 minutes over a period of 3 months, with monitoring to ensure safety. The control group participated in regular physical activity of similar duration and frequency but without the targeted diabetic foot exercise components.

Peripheral vascular status was assessed through the ankle-brachial index (ABI), using a Doppler device (ES-1000SPM, Hadeco, Japan). ABI measurements were taken at baseline and after 3 months of intervention, following standard procedures, including supine positioning and an initial rest period of five minutes. ABI categories followed established clinical thresholds: normal (0.90-1.30), mild impairment (0.70-0.89), moderate impairment (0.40-0.69), and severe impairment (<0.40).

Data analysis was performed using SPSS, employing paired t-tests for within-group comparisons and independent t-tests for between-group differences. The results demonstrated a significant improvement in ABI values in the intervention group (from 0.90 ± 0.05 to 0.96 ± 0.06), compared to minimal changes in the control group (from 0.90 ± 0.04 to 0.91 ± 0.05). These findings suggest that diabetic foot exercises can effectively enhance peripheral vascular function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged > 50 years
  • Diagnosed with Type 2 Diabetes Mellitus for ≥ 5 years
  • Able to walk independently
  • Willing to participate for the full 3-month intervention period
  • Provided written informed consent

排除标准

  • patients who unable to walk independently, had lower limb pain, severe arthritis, cardiovascular or neurological disorders, limited physical activity, or cognitive dysfunction that impaired their ability to follow instructions.

结局指标

主要结局

Change in Ankle-Brachial Index (ABI)

时间窗: Baseline and 3 months after intervention

Ankle-Brachial Index (ABI) is measured using a handheld Doppler device (ES-1000SPM, Hadeco, Japan). ABI is calculated as the highest ankle systolic pressure (posterior tibial or dorsalis pedis) divided by the highest brachial systolic pressure. Measurements are taken in supine position after 5 minutes rest. ABI values reflect peripheral vascular status, categorized as normal (0.90-1.30), mild (0.70-0.89), moderate (0.40-0.69), and severe (\<0.40). Primary analysis compares the change in ABI from baseline to 3 months between intervention and control groups

次要结局

未报告次要终点

研究者

发起方
Universitas Muhammadiyah Surakarta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fahrun Nur Rosyid

Dr.Fahrun Nur Rosyid, S.Kep., Ns., M .Kes

Universitas Muhammadiyah Surakarta

研究点 (2)

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