The Effectiveness of Strength and Balance Training in Patients With Diabetic Peripheral Neuropathy on Quality of Life and Functional Status: a Randomized Controlled Trial With Cost-utility Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Change in Physical health component summary (PCS) of HRQoL from baseline at 2 and 6 months
研究概览
简要总结
People with diabetes can have nerve damage in their extremities (peripheral neuropathy), and this can lead them to being less able to maintain their balance when they are standing, walking or performing complex movement tasks in their day-to-day life. This results in them being more prone to falls, and consequent injuries. The purpose of this study is to determine whether providing strength and balance retraining (in the form of specific physical exercises or activities) can help people with diabetic peripheral neuropathy regain their ability to maintain their balance, increase their confidence in performing balance-based activities and improve their quality of life.
详细描述
Individuals with diabetic peripheral neuropathy (DPN) comprise 16-24% of patients with diabetes mellitus in Singapore, and this is set to rise with the increasing prevalence of diabetes. DPN is also associated with the greatest reduction in health related quality of life (HRQoL) among all diabetic complications, specifically PCS (Physical health Component Summary) and its sub-components, physical functioning and physical role. However, there is currently no intervention that targets individuals with DPN for improvements in HRQoL and functional status.
The investigators hypothesise that a targeted intervention providing strength and balance training will improve HRQoL and functional status in patients with DPN, which will be sufficiently large relative to increases in cost to make the intervention cost-efficient.
The specific aims of the study are to test the effectiveness of a structured strength and balance training intervention in 1) improving the physical health component summary (PCS) measure of health related quality of life, 2) functional status, and 3) assessing cost-utility of the intervention, in individuals with diabetic peripheral neuropathy (DPN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 40 - 75
- •Clinical diagnosis of Type II Diabetes Mellitus
- •Presence of peripheral neuropathy (defined as neurothesiometer reading greater than 25 V and/or positive monofilament test in 2 or more sites in either foot)
排除标准
- •Foot ulceration/ infection/ amputation
- •Medical contraindication for physical activity or physiotherapy
- •Non-diabetic neuropathy
- •Orthopaedic/ Surgical/ Medical conditions affecting functional mobility and balance not due to diabetes or neuropathy (E.g. Stroke, Prosthesis use, Osteoarthritis)
- •Retinopathy
- •End-Stage Renal Disease requiring dialysis
- •Congestive Heart Failure
结局指标
主要结局
Change in Physical health component summary (PCS) of HRQoL from baseline at 2 and 6 months
时间窗: Baseline, 2 and 6 months
Physical Component Summary measured by SF-36 v2 questionnaire (norm-based score with mean of 50 and SD of 10 in general population)
Change in EQ5D HUI from baseline at 2 and 6 months
时间窗: Baseline, 2 and 6 months
Health Utility Index measured using EQ5D (range 0-1)
次要结局
- Change in static balance from baseline at 2 and 6 months(Baseline, 2 and 6 months)
- Cost-utility of intervention measured by cost per Quality-Adjusted Life Year (QALY) gained(2 months of intervention)
- Change in other domains of HRQoL from baseline at 2 and 6 months(Baseline, 2 and 6 months)
- Change in Functional Status from baseline at 2 and 6 months(Baseline, 2 and 6 months)
研究者
Kavita Venkataraman
Assistant Professor, Saw Swee Hock School of Public Health, National University of Singapore (NUS) and National University Health System (NUHS)
National University Health System, Singapore