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

Diabetic Neuropathies Clinical Trial

— DPN-QoL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02115932
• Other study ID #: NMRC/TA/0022/2013
• Status: Completed
• Phase: N/A
• Start date: July 30, 2014
• Est. completion date: March 16, 2018

Study information

• Verified date: July 2018
• Source: National University Health System, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Nervous System Diseases
• Peripheral Nervous System Diseases

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University of Singapore; National University Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University Health System, Singapore	National Medical Research Council (NMRC), Singapore, National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in range of motion at ankle and knee from baseline at 2 and 6 months	range of motion at ankle and knee measured using a hand-held inclinometer	Baseline, 2 and 6 months
Other	Number of subjects reporting falls and Injuries during the study	Subjected-reported falls and injuries	6 months
Other	Change in gait from baseline at 2 and 6 months	gait measured by a gait analysis platform	Baseline, 2 and 6 months
Primary	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
Primary	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
Secondary	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
Secondary	Change in Functional Status from baseline at 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
Secondary	Change in static balance from baseline at 2 and 6 months	static balance measured by a portable balance platform	Baseline, 2 and 6 months
Secondary	Cost-utility of intervention measured by cost per Quality-Adjusted Life Year (QALY) gained		2 months of intervention