Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Medical Research Council (NMRC), Singapore | OTHER_GOV |
| National University Hospital, Singapore | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strength & Balance Training Intervention | Experimental | Subjects in this arm will undergo once weekly home-based strength and balance training for a period of 8 weeks. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical health component summary (PCS) of HRQoL from baseline at 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 | Health Utility Index measured using EQ5D (range 0-1) | Baseline, 2 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in other domains of HRQoL from baseline at 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in muscle strength at ankle from baseline at 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kavita Venkataraman, MBBS, PhD | National University of Singapore (NUS), and National University Health System (NUHS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Singapore; National University Hospital | Singapore | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22775311 | Background | 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. | |
| 23538652 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| D048909 | Diabetes Complications |
| D017719 | Diabetic Foot |
| D004700 | Endocrine System Diseases |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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 | 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 | 2 months of intervention |
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 | Subjected-reported falls and injuries | 6 months |
| Change in gait from baseline at 2 and 6 months | gait measured by a gait analysis platform | Baseline, 2 and 6 months |
| 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. |
| 29185052 | Background | 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. |
| 31468106 | Derived | 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. |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |