DPN-QoL: Effect of Physical Therapy in Improving the Health of Patients With Diabetic Peripheral Neuropathy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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:
|
| 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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]
Other Outcome Measures
- Change in muscle strength at ankle from baseline at 2 and 6 months [Baseline, 2 and 6 months]
muscle strength at ankle measured using a hand-held dynamometer
- Change in range of motion at ankle and knee from baseline at 2 and 6 months [Baseline, 2 and 6 months]
range of motion at ankle and knee measured using a hand-held inclinometer
- Number of subjects reporting falls and Injuries during the study [6 months]
Subjected-reported falls and injuries
- Change in gait from baseline at 2 and 6 months [Baseline, 2 and 6 months]
gait measured by a gait analysis platform
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals aged 40 - 75
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Clinical diagnosis of Type II Diabetes Mellitus
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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:
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Foot ulceration/ infection/ amputation
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Medical contraindication for physical activity or physiotherapy
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Non-diabetic neuropathy
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Orthopaedic/ Surgical/ Medical conditions affecting functional mobility and balance not due to diabetes or neuropathy (E.g. Stroke, Prosthesis use, Osteoarthritis)
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Retinopathy
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End-Stage Renal Disease requiring dialysis
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Congestive Heart Failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National University of Singapore; National University Hospital | Singapore | Singapore |
Sponsors and Collaborators
- National University Health System, Singapore
- National Medical Research Council (NMRC), Singapore
- National University Hospital, Singapore
Investigators
- Principal Investigator: Kavita Venkataraman, MBBS, PhD, National University of Singapore (NUS), and National University Health System (NUHS)
Study Documents (Full-Text)
None provided.More Information
Publications
- Alfonso-Rosa RM, Del Pozo-Cruz B, Del Pozo-Cruz J, Del Pozo-Cruz JT, Sañudo 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.
- 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.
- NMRC/TA/0022/2013