Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking on Pain, Foot and Ankle Disability and Quality of Life in Patients With Diabetic Polyneuropathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale
研究概览
简要总结
The aim of this study is to investigate the combined effects of foot ankle therapeutic exercises and mindful walking on pain, foot and ankle disability, and quality of life in patients with diabetic polyneuropathy. This study seeks to evaluate the efficacy of these interventions in improving clinical outcomes and enhancing the overall well-being of individuals with diabetic polyneuropathy.
详细描述
A 12-week foot-ankle therapeutic exercise program has been found to show positive effects compared to usual care on fast-gait speed, foot-ankle range of motion, vibration sensitivity, and quality of life in people with diabetic neuropathy.
Mindful walking's efficacy for chronic low back pain management has been investigated, with a randomized controlled trial of 55 patients yielding no significant improvements in pain intensity, back function, or stress after 8 weeks.
Exercise therapy has been found to significantly improve gait function in patients with diabetic peripheral neuropathy. A systematic review of 9 randomized controlled trials (370 participants) showed that exercise therapy enhances 6-minute walk test, 10-meter walk test, and Tinetti scale outcomes, improving mobility and reducing fall risk.
Exercise shows therapeutic potential for sensory nerve disorders, improving symptoms in most cases. Benefits are seen in diabetic pain and nerve damage, with varying mechanisms underlying these effects. Exercise therapy enhances outcomes for various nerve-related disorders, improving symptoms by at least two times compared to no exercise.
A 12-week study found significant improvements in glycemic control and vascular function in patients with type 2 diabetes who practiced Buddhist walking meditation, whereas traditional walking only improved blood glucose levels and cardiovascular fitness.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Months 至 75 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with diabetic polyneuropathy (DPN) confirmed by medical history and clinical examination.
- •Experience pain and disability in foot/ankle, with a Numeric Pain Rating Scale (NPRS) score ≥
- •Independent walking ability for at least 10 m.
- •Age (40-75) years.
- •Ability to understand and follow exercise instructions.
- •A maximum of one amputated toe, not being the hallux.
- •Willingness to participate in the study and provide informed consent.
排除标准
- •Presence of an active plantar ulcer or gangrene.
- •History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period.
- •Arthroplasty and/or orthosis of lower limbs or indication of lower limb arthroplasty throughout the intervention period.
- •Participating in other exercise programs or studies.
- •Dementia or inability to give consistent information.
- •Diagnosis of neurological diseases.
- •Neuropathic pain due to other causes (e.g., HIV, chemotherapy).
- •Major vascular complications and/or severe retinopathy.
结局指标
主要结局
Numeric Pain Rating Scale
时间窗: At baseline and 12 weeks
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次要结局
未报告次要终点