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Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy (DPN)

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ClinicalTrials.gov Identifier: NCT02541838
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
VA Maryland Health Care System
Information provided by (Responsible Party):
Mark W. Rogers, University of Maryland, College Park

Brief Summary:
Type 2 diabetes results in a host of neuromuscular, muscular, and autonomic system impairments that accelerate age-associated limitations in functional independence and the risk of falls. Diabetic peripheral neuropathy (DPN) contributes to functional declines in balance and mobility because of limitations metabolic abnormalities. The constellation of impairments accompanying type 2 diabetes diminishes muscle function and performance including strength and power. Loss of strength at higher speeds of movement (deficit in power) occurs in neural activation of muscles, changes in muscle properties, and through in older individuals with DPN compared to older controls. Consequently, this deficit in speed dependent muscle power production leads to limitations in rapidly responding to sudden loss of balance stability to prevent falling. The goal of this pilot research program is to determine the feasibility and effectiveness of a mechanism-based therapeutic intervention fro improving balance and mobility functions and preventing falls in older adults with DPN. The investigators pan to use the results from this pilot study to design and implement a larger randomized control trial.

Condition or disease Intervention/treatment Phase
Diabetes Complications Diabetic Neuropathies Other: Muscle power Other: balance perturbation Other: aerobic exercise Not Applicable

Detailed Description:

The long-term goal of this research is to establish the effectiveness of a mechanism-based therapeutic intervention for improving balance and mobility functions and preventing falls in older adults with type 2 diabetic peripheral neuropathy (DPN).

Specific Aim 1 will determine if combined high intensity isolated leg muscle power exercise with balance perturbation training (ActiveStep) and aerobic exercise achieves greater improvements in balance stabilization (protective stepping behavior and kinematics) and mobility function (gait parameters and timed functional measures) than a lifestyle based intervention that primarily focuses on aerobic exercise through underlying mechanisms of improved neuromuscular activation (rate and magnitude) and sensorimotor control, improved muscle quality, and increased blood flow to enhance neuromuscular and sensorimotor performance in people with DPN.

Specific Aim #2: To determine if a neuromotor balance training program combined with muscle power exercise training and aerobic exercise, leading to improved neuromuscular and sensorimotor mechanisms, is more effective in improving clinical tests of balance and mobility functions in those with DPN compared with a traditional exercise intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Muscle Power and Balance Perturbation Training to Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
Actual Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Muscle, Balance, and aerobic exercise
This trial will have a single experimental arm that will include the following interventions: Leg muscle strengthening, balance training using balance perturbations, and aerobic exercise. All individuals in this trial will receive all interventions listed.
Other: Muscle power
Other: balance perturbation
Other: aerobic exercise



Primary Outcome Measures :
  1. Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months [ Time Frame: baseline, 3 months, and 6 months ]
    A Computed Tomography Scan will be used to measure the cross sectional area of the leg muscles in cm. Changes from baseline to 3 and 6 months will be examined.

  2. Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months [ Time Frame: baseline, 3 months, and 6 months ]
    A strength testing machine will be used to test the strength of the legs in newton meters. Changes from baseline to 3 and 6 months will be examined.

  3. Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months [ Time Frame: baseline, 3 months, and 6 months ]
    heart rate variability will be measured by placing electrodes near the heart similar to an EKG. Changes in heart rate variability from baseline to 3 and 6 months will be examined.

  4. Change in protective stepping as determined by the number of steps it take to recover from a balance perturbation from baseline to 3 months and baseline to 6 months [ Time Frame: baseline, 3 months, and 6 months ]
    A machine that pulls individuals side to side will be used to measure the number of steps required to recover balance after a pull. Changes from baseline to 3 and 6 months will be examined.


Secondary Outcome Measures :
  1. Change in clinical balance as measured by the Four Square Step Test [ Time Frame: baseline, 3 months, and 6 months ]
    The Four Square Step Test (FSST) will be used to evaluate changes in clinical balance. The FSST is a single item, evaluator-administered tool that assesses the ability to change directions while stepping. It requires the individuals to move in the anterior-posterior and medial-lateral directions while stepping. Changes from baseline to 3 and 6 months will be examined.

  2. Change in mobility as measured by the modified physical performance test [ Time Frame: baseline, 3 months, and 6 months ]
    The modified physical performance test will be used to evaluate changes in mobility. This test requires individuals to perform a variety of every day tests such as going up and down the stairs, standing from a chair, and putting on a coat. Changes from baseline to 3 and 6 months will be examined.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HbA1C of 5.7% to 9.0% or a fasting blood glucose of greater than or equal to 100
  • Participants that are diabetic should be stable on medications for at least 3 months prior to entering the study
  • Neuropathy is most likely caused by impaired glucose regulation determined by medical or family history
  • Autonomic neuropathy as defined by Toronto Neuropathy Expert Group 2010/2011 consensus criteria
  • Medically stable at time of enrollment as determined by screening process

Exclusion Criteria:

  • Neuropathy due to factors other than impaired glucose regulation determined by screening process
  • Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team
  • Severe Autonomic Neuropathy that would limit study participation
  • Musculoskeletal limitations that would preclude participation in balance assessment of protective stepping

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541838


Locations
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United States, Maryland
PTRS Research Lab
Baltimore, Maryland, United States, 21201
VA Maryland Health Care System
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, College Park
VA Maryland Health Care System

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Responsible Party: Mark W. Rogers, Professor and Department Chair, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT02541838    
Other Study ID Numbers: HP-00064233
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Mark W. Rogers, University of Maryland, College Park:
Autonomic Neuropathy
diabetes
balance control
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Diabetes Complications
Neuromuscular Diseases
Nervous System Diseases
Diabetes Mellitus
Endocrine System Diseases