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

Not Applicable

Completed

• Conditions: Diabetic Neuropathies; Peripheral Nervous System Diseases
• Interventions: Other: Strength & Balance Training

• Registration Number: NCT02115932
• Lead Sponsor: National University Health System, Singapore

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2014-04-11
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-16
• Study Start: 2014-07-30
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-07
• Last Update Posted: 2018-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Strength & Balance Training Intervention	Strength & Balance Training	Subjects in this arm will undergo once weekly home-based strength and balance training for a period of 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Physical health component summary (PCS) of HRQoL from baseline at 2 and 6 months	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	Baseline, 2 and 6 months	Health Utility Index measured using EQ5D (range 0-1)

Secondary Outcome Measures

Name	Time	Method
Change in static balance from baseline at 2 and 6 months	Baseline, 2 and 6 months	static balance measured by a portable balance platform
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	Domains of HRQoL measured by SF-36 v2 questionnaire ((norm-based score with mean of 50 and SD of 10 in general population)
Change in Functional Status from baseline at 2 and 6 months	Baseline, 2 and 6 months	Functional Status measured using Timed Up and Go, Sit to Stand 5, Functional Reach, and activities based balance confidence tests

Trial Locations

Locations (1)

National University of Singapore; National University Hospital; 🇸🇬 Singapore, Singapore