Skip to main content
OpenTrials
Completed

NCT Number: NCT02115932

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Neuropathies Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Angiopathies Diabetic Foot Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nervous System Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Peripheral Nervous System Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University of Singapore; National University Hospital

Singapore

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strength & Balance Training

Other

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.

Other names: Exercise Training, Gait Training, Motor Learning, Balance performance, Physical activity, Physiotherapy, Guided-exercise

Primary outcomes

  1. Change in Physical health component summary (PCS) of HRQoL from baseline at 2 and 6 months

    Time frame: 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)

  2. Change in EQ5D HUI from baseline at 2 and 6 months

    Time frame: Baseline, 2 and 6 months

    Health Utility Index measured using EQ5D (range 0-1)

Secondary outcomes

  1. Change in other domains of HRQoL from baseline at 2 and 6 months

    Time frame: 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)

  2. Change in Functional Status from baseline at 2 and 6 months

    Time frame: 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

  3. Change in static balance from baseline at 2 and 6 months

    Time frame: Baseline, 2 and 6 months

    static balance measured by a portable balance platform

  4. Cost-utility of intervention measured by cost per Quality-Adjusted Life Year (QALY) gained

    Time frame: 2 months of intervention

Other outcomes

  1. Change in muscle strength at ankle from baseline at 2 and 6 months

    Time frame: Baseline, 2 and 6 months

    muscle strength at ankle measured using a hand-held dynamometer

  2. Change in range of motion at ankle and knee from baseline at 2 and 6 months

    Time frame: Baseline, 2 and 6 months

    range of motion at ankle and knee measured using a hand-held inclinometer

  3. Number of subjects reporting falls and Injuries during the study

    Time frame: 6 months

    Subjected-reported falls and injuries

  4. Change in gait from baseline at 2 and 6 months

    Time frame: Baseline, 2 and 6 months

    gait measured by a gait analysis platform

Sponsors and collaborators

Lead sponsor

National University Health System, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore
  • National University Hospital, Singapore

Registry information

Official study title

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

Acronym: DPN-QoL

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 16, 2014
Registry last updated
Jul 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.