Clinical trial NCT02115932: Effect of Physical Therapy in Improving the Health of Patients With Diabetic Peripheral Neuropathy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Peripheral Nervous System Diseases
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Complications
Diabetic Foot
Diabetic Neuropathies
Gait
Balance, Postural
Muscle Strength
Exercise Therapy
Physical Therapy Modalities
Endocrine System Diseases
Peripheral Nervous System Diseases
Metabolic Diseases
Glucose Metabolism Diseases
Quality of Life
Training
Lead sponsor: National University Health System, Singapore
Sponsor class: OTHER
Collaborators: name: National Medical Research Council (NMRC), Singapore
name: National University Hospital, Singapore
First posted: 2014-04-16
Enrollment: 143
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical health component summary (PCS) of HRQoL from baseline at 2 and 6 months
timeFrame: Baseline, 2 and 6 months
measure: Change in EQ5D HUI from baseline at 2 and 6 months
timeFrame: Baseline, 2 and 6 months
Secondary outcomes:
measure: Change in other domains of HRQoL from baseline at 2 and 6 months
timeFrame: Baseline, 2 and 6 months
measure: Change in Functional Status from baseline at 2 and 6 months
timeFrame: Baseline, 2 and 6 months
measure: Change in static balance from baseline at 2 and 6 months
timeFrame: Baseline, 2 and 6 months
measure: Cost-utility of intervention measured by cost per Quality-Adjusted Life Year (QALY) gained
timeFrame: 2 months of intervention
Other outcomes:
measure: Change in muscle strength at ankle from baseline at 2 and 6 months
timeFrame: Baseline, 2 and 6 months
measure: Change in range of motion at ankle and knee from baseline at 2 and 6 months
timeFrame: Baseline, 2 and 6 months
measure: Number of subjects reporting falls and Injuries during the study
timeFrame: 6 months
measure: Change in gait from baseline at 2 and 6 months
timeFrame: Baseline, 2 and 6 months
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore; National University Hospital
Study officials:
affiliation: National University of Singapore (NUS), and National University Health System (NUHS)
name: Kavita Venkataraman, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Venkataraman K, Tai BC, Khoo EYH, Tavintharan S, Chandran K, Hwang SW, Phua MSLA, Wee HL, Koh GCH, Tai ES. Short-term strength and balance training does not improve quality of life but improves functional status in individuals with diabetic peripheral neuropathy: a randomised controlled trial. Diabetologia. 2019 Dec;62(12):2200-2210. doi: 10.1007/s00125-019-04979-7. Epub 2019 Aug 29.