Effect of Structured Training Program on Functional Abilities in Patients With Diabetic Neuropathy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Michigan neuropathy screening instrument (MNSI)
研究概览
简要总结
Diabetic neuropathy, a challenging condition resulting from poorly managed type-1 or type-2 diabetes mellitus, often proves resistant to conventional medications when it comes to alleviating the associated symptoms. In such cases, implementing a well-organized exercise regimen has proven beneficial in mitigating diverse symptoms associated with the condition and enhancing the overall quality of life for affected individuals.
详细描述
The goal of this type of interventional study is to assess the effect a well-defined exercise program for individuals with DPN, despite the existence of various individualized exercise programs designed for DPN patients. The main questions this study aims to answer is:
What is the effect of a 4-weeks structured training program as an adjunct to general lower limb exercise in patients with DPN on pain, sensory symptoms, balance, vibration sense and Quality of life?
Group 1:
Patients in group 1 will receive a structured exercise program.
Group 2:
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 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diabetes mellitus with moderate to severe DPN
- •Subjects of both gender
- •Age from 40 to 70 years
- •Independent walking
- •MNSI score more than 2 out of 13
排除标准
- •Presence of an active planter ulcer
- •History of surgery during intervention period
- •Neurological diseases other than DPN
研究组 & 干预措施
Group-1 (Structured Exercise Program)
Patients undergo structured exercise sessions lasting 30 minutes, encompassing activities such as range of motion, flexibility exercises, strength training, balance exercises, and aerobic exercises, with designated intervals between each session.
干预措施: Structured Exercise Program (Other)
Group-2 (Non-Structured Exercise Program)
Patients are provided with a simple exercise routine that lacks a structured format.
干预措施: Non structured exercise program (Other)
结局指标
主要结局
Michigan neuropathy screening instrument (MNSI)
时间窗: The measurement will be taken during the baseline assessment and again after the completion of treatment.
The scale consists of two parts: the first part involves a patient history assessment, while the second part focuses on physical examination. This scale is considered both reliable and practical for evaluating the severity of neuropathy. If the patient's score increases, it indicates a higher severity of the disease, whereas if the score decreases, it suggests a lower severity.
Biothesiometer
时间窗: The measurement will be taken during the baseline assessment and again after the completion of treatment.
This objective measure is utilized to assess the vibratory pressure threshold in affected areas. It possesses the capability to detect various frequencies for vibratory pressure threshold assessment. It is regarded as a practical tool for evaluating both superficial and vibratory sensations. If there is an increased perception of frequency, it indicates that the vibratory pressure threshold is more severely affected.
NeuroQoL
时间窗: The measurement will be taken during the baseline assessment and again after the completion of treatment.
The Neuropathy-and Foot-Ulcer Specific Quality of Life Instrument is designed as a Likert scale and serves as a reliable method for assessing quality of life related to neuropathy. If the scoring indicates a higher value, it suggests that the disease is more severe.
次要结局
- NPRS(The measurement will be taken during the baseline assessment and again after the completion of treatment.)
研究者
Subhasish Chatterjee
Clinical Professor
Maharishi Markendeswar University (Deemed to be University)