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

July 7, 2018 updated by: Kavita Venkataraman, National University Health System, Singapore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University of Singapore; National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strength & Balance Training Intervention
Subjects in this arm will undergo once weekly home-based strength and balance training for a period of 8 weeks.
Other: Strength & Balance Training
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:
  • Physical activity
  • Physiotherapy
  • Exercise Training
  • Gait Training
  • Motor Learning
  • Balance performance
  • Guided-exercise
No Intervention: Control
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?

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
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)
Baseline, 2 and 6 months
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)
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
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)
Baseline, 2 and 6 months
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
Baseline, 2 and 6 months
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
Baseline, 2 and 6 months
Cost-utility of intervention measured by cost per Quality-Adjusted Life Year (QALY) gained
Time Frame: 2 months of intervention
2 months of intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 2 and 6 months
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
Baseline, 2 and 6 months
Number of subjects reporting falls and Injuries during the study
Time Frame: 6 months
Subjected-reported falls and injuries
6 months
Change in gait from baseline at 2 and 6 months
Time Frame: Baseline, 2 and 6 months
gait measured by a gait analysis platform
Baseline, 2 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Health System, Singapore

Collaborators

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

Investigators

  • Principal Investigator: Kavita Venkataraman, MBBS, PhD, National University of Singapore (NUS), and National University Health System (NUHS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2014

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Actual)

July 10, 2018

Last Update Submitted That Met QC Criteria

July 7, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NMRC/TA/0022/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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