Effect of Physical Therapy in Improving the Health of Patients With Diabetic Peripheral Neuropathy (DPN-QoL)

National University Health System, Singapore

Status: Completed

Conditions: Peripheral Nervous System Diseases; Diabetic Neuropathies

Treatments: Other: Strength & Balance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT02115932

NMRC/TA/0022/2013

Details and patient eligibility

About

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.

Full 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).

Enrollment: 143 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

Strength & Balance Training Intervention

Experimental group

Description:

Subjects in this arm will undergo once weekly home-based strength and balance training for a period of 8 weeks.

Treatment:

Other: Strength & Balance Training

Control

No Intervention group

Description:

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.