Effect of Physical Therapy in Improving the Health of Patients With Diabetic Peripheral Neuropathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Diabetic Neuropathies, Peripheral Nervous System Diseases

Intervention / Treatment
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* Other: Strength & Balance Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Strength & Balance Training Intervention<br>Subjects in this arm will undergo once weekly home-based strength and balance training for a period of 8 weeks. | Other: Strength & Balance Training<br>* Subjects will be guided through 8 weeks (1 hour per week) of home-based strength and balance training sessions. During each session, a trainer will guide subjects to perform muscle strengthening, range of motion, static balance, dynamic balance and endurance exercises, after an initial warm up. They will also be given advice on continuing such training as well as daily walking for the rest of the week.<br>* Other names: Guided-exercise;|
| No Intervention: Control<br>Subjects in this arm will not undertake any procedures or activities related to the study. They will continue with their prescribed medication and other medical advice from their treating physician as per usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical health component summary (PCS) of HRQoL from baseline at 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) | Baseline, 2 and 6 months | 
| Change in EQ5D HUI from baseline at 2 and 6 months | Health Utility Index measured using EQ5D (range 0-1) | Baseline, 2 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in other domains of HRQoL from baseline at 2 and 6 months | Domains of HRQoL measured by SF-36 v2 questionnaire ((norm-based score with mean of 50 and SD of 10 in general population) | Baseline, 2 and 6 months | 
| Change in Functional Status from baseline at 2 and 6 months | Functional Status measured using Timed Up and Go, Sit to Stand 5, Functional Reach, and activities based balance confidence tests | Baseline, 2 and 6 months | 
| Change in static balance from baseline at 2 and 6 months | static balance measured by a portable balance platform | Baseline, 2 and 6 months | 
| Cost-utility of intervention measured by cost per Quality-Adjusted Life Year (QALY) gained |  | 2 months of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Foot, Diabetic Neuropathies, Gait, Balance, Postural, Muscle Strength, Exercise Therapy, Physical Therapy Modalities, Endocrine System Diseases, Peripheral Nervous System Diseases, Metabolic Diseases, Glucose Metabolism Diseases, Quality of Life, Training