Effect of Physical Therapy in Improving the Health of Patients With Diabetic Peripheral Neuropathy (DPN-QoL)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Medical Research Council (NMRC), Singapore
National University Hospital, Singapore
Information provided by (Responsible Party):
Kavita Venkataraman, National University Health System, Singapore
ClinicalTrials.gov Identifier:
NCT02115932
First received: April 11, 2014
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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 Intervention
Diabetic Neuropathies
Peripheral Nervous System Diseases
Other: Strength & Balance Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National University Health System, Singapore:

Primary Outcome Measures:
  • Change in Physical health component summary (PCS) of HRQoL measured by SF-36 v2 questionnaire from baseline at 2 months [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in other domains of HRQoL measured by SF-36 v2 questionnaire from baseline at 2 months [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
  • Change in Functional Status measured by functional testing from baseline at 2 months [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
  • Cost-utility of intervention measured by cost per Quality-Adjusted Life Year (QALY) gained [ Time Frame: 2 months of intervention ] [ Designated as safety issue: No ]
  • Change in other domains of HRQoL measured by SF-36 v2 questionnaire from baseline at 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Functional Status measured by functional testing from baseline at 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in balance measured by a portable balance platform from baseline at 2 months [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
  • Change in balance measured by a portable balance platform from baseline at 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in Physical health component summary (PCS) of HRQoL measured by SF-36 v2 questionnaire from baseline at 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of subjects reporting falls and Injuries during the study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Change in muscle strength at ankle using a hand-held dynamometer from baseline at 2 months [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
  • Change in muscle strength at ankle using a hand-held dynamometer from baseline at 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]
  • Change in gait measured by a gait analysis platform from baseline at 2 months [ Time Frame: Baseline and 2 months ] [ Designated as safety issue: No ]
  • Change in gait measured by a gait analysis platform from baseline at 6 months [ Time Frame: Baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: July 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Exercise Training
  • Gait Training
  • Motor Learning
  • Balance performance
  • Physical activity
  • Physiotherapy
  • Guided-exercise
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.

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

Ages Eligible for Study:   45 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals aged 45 - 69
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02115932

Locations
Singapore
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)
  More Information

Publications:
Responsible Party: Kavita Venkataraman, Assistant Professor, Saw Swee Hock School of Public Health, National University of Singapore (NUS) and National University Health System (NUHS), National University Health System, Singapore
ClinicalTrials.gov Identifier: NCT02115932     History of Changes
Other Study ID Numbers: NMRC/TA/0022/2013
Study First Received: April 11, 2014
Last Updated: August 12, 2014
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Health System, Singapore:
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

Additional relevant MeSH terms:
Diabetic Neuropathies
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 18, 2014