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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: March 16, 2018

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).

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National University Health System, Singapore
  • Collaborator
    • National Medical Research Council (NMRC), Singapore
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kavita Venkataraman, Assistant Professor, Saw Swee Hock School of Public Health, National University of Singapore (NUS) and National University Health System (NUHS) – National University Health System, Singapore
  • Overall Official(s)
    • Kavita Venkataraman, MBBS, PhD, Principal Investigator, National University of Singapore (NUS), and National University Health System (NUHS)

References

Venkataraman K, Wee HL, Leow MK, Tai ES, Lee J, Lim SC, Tavintharan S, Wong TY, Ma S, Heng D, Thumboo J. Associations between complications and health-related quality of life in individuals with diabetes. Clin Endocrinol (Oxf). 2013 Jun;78(6):865-73. doi: 10.1111/j.1365-2265.2012.04480.x. Epub 2013 Mar 25.

Alfonso-Rosa RM, Del Pozo-Cruz B, Del Pozo-Cruz J, Del Pozo-Cruz JT, Sanudo B. The relationship between nutritional status, functional capacity, and health-related quality of life in older adults with type 2 diabetes: a pilot explanatory study. J Nutr Health Aging. 2013 Apr;17(4):315-21. doi: 10.1007/s12603-013-0028-5.

Riandini T, Wee HL, Khoo EYH, Tai BC, Wang W, Koh GCH, Tai ES, Tavintharan S, Chandran K, Hwang SW, Venkataraman K. Functional status mediates the association between peripheral neuropathy and health-related quality of life in individuals with diabetes. Acta Diabetol. 2018 Feb;55(2):155-164. doi: 10.1007/s00592-017-1077-8. Epub 2017 Nov 28.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.