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Diabetic NeuropathiesDPN-QoLNCT02115932

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

A study testing Strength & Balance Training in people with Diabetic Neuropathies and Peripheral Nervous System Diseases, run by National University Health System, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 75 years
What is being tested?
Strength & Balance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
143 participants
Where
1 siteSingapore
Study dates
30 Jul 2014to 16 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University of Singapore; National University Hospital

    Singapore

Other trials in Singapore

About this study

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

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.

Read the 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).

Being tested
Strength & Balance Training
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
Medical subject headings
Diabetic Neuropathies, Peripheral Nervous System Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Complications, Diabetic Foot, Endocrine System Diseases, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength & Balance TrainingOther

    Also called Exercise Training, Gait Training, Motor Learning, Balance performance

    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.

Study groups in NCT02115932
Study groupRoleWhat they receive
Strength & Balance Training InterventionExperimentalSubjects in this arm will undergo once weekly home-based strength and balance training for a period of 8 weeks.
Receives: Other: Strength & Balance Training
ControlNo interventionSubjects 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline, 2 and 6 months

  2. Change in EQ5D HUI from baseline at 2 and 6 months

    Health Utility Index measured using EQ5D (range 0-1)

    Measured: Baseline, 2 and 6 months

Secondary outcomes (4)

  1. 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)

    Measured: Baseline, 2 and 6 months

  2. 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

    Measured: Baseline, 2 and 6 months

  3. Change in static balance from baseline at 2 and 6 months

    static balance measured by a portable balance platform

    Measured: Baseline, 2 and 6 months

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

    Measured: 2 months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2014 (estimated)
  2. Study start30 Jul 2014
  3. Primary completion16 Mar 2018
  4. Study completion16 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
143 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02115932
Sponsor's protocol ID
NMRC/TA/0022/2013
Acronym
DPN-QoL
Status last verified
Jul 2018
First submitted
11 Apr 2014
Last updated
10 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22775311

  • 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.

    PubMed 23538652

  • 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.

    PubMed 29185052

  • 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.

    PubMed 31468106

Questions about this trial

What is this clinical trial studying?

A study testing Strength & Balance Training in people with Diabetic Neuropathies and Peripheral Nervous System Diseases, run by National University Health System, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Physical health component summary (PCS) of HRQoL from baseline at 2 and 6 months (time frame: Baseline, 2 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02115932, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.

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