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

NCT02115932 | Completed DMC

• 1 other identifier: NMRC/TA/0022/2013
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Change in other domains of HRQoL from baseline at 2 and 6 months

  Baseline, 2 and 6 months

• Change in Functional Status from baseline at 2 and 6 months

  Baseline, 2 and 6 months

• Change in static balance from baseline at 2 and 6 months

  Baseline, 2 and 6 months

• Cost-utility of intervention measured by cost per Quality-Adjusted Life Year (QALY) gained

  2 months of intervention

Other Outcomes (4)

• Change in muscle strength at ankle from baseline at 2 and 6 months

  Baseline, 2 and 6 months

• Change in range of motion at ankle and knee from baseline at 2 and 6 months

  Baseline, 2 and 6 months

• Number of subjects reporting falls and Injuries during the study

  6 months

Study Arms (2)

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.

Other: Strength & Balance Training

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.

Interventions

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.

Also known as: Exercise Training, Gait Training, Motor Learning, Balance performance, Physical activity, Physiotherapy, Guided-exercise

Strength & Balance Training Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Health System, Singapore: lead
• National Medical Research Council (NMRC), Singapore: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (1)

National University of Singapore; National University Hospital

Singapore, Singapore

Location

Related Publications (4)

• 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.

  PMID: 22775311 BACKGROUND

• 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.

  PMID: 23538652 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.

  PMID: 29185052 BACKGROUND

• 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.

  PMID: 31468106 DERIVED

MeSH Terms

Conditions

Diabetic Neuropathies; Peripheral Nervous System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications; Diabetic Foot; Endocrine System Diseases; Metabolic Diseases

Interventions

Exercise; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Rehabilitation

Study Officials

• Kavita Venkataraman, MBBS, PhD

  National University of Singapore (NUS), and National University Health System (NUHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Saw Swee Hock School of Public Health, National University of Singapore (NUS) and National University Health System (NUHS)

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 16, 2014
• Study Start: July 30, 2014
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2018
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

SG (1)