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

Primary Purpose

Diabetes Complications, Diabetic Neuropathies

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Muscle power
balance perturbation
aerobic exercise
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Complications focused on measuring Autonomic Neuropathy, diabetes, balance control

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Maryland School of Medicine
  • VA Maryland Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Muscle, Balance, and aerobic exercise

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 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.
Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 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.
Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 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.
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
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

Change in clinical balance as measured by the Four Square Step Test
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.
Change in mobility as measured by the modified physical performance test
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.

Full Information

First Posted
September 1, 2015
Last Updated
January 14, 2022
Sponsor
University of Maryland, Baltimore
Collaborators
VA Maryland Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT02541838
Brief Title
Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
Acronym
DPN
Official Title
High Intensity Muscle Power and Balance Perturbation Training to Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Poor recruitment
Study Start Date
May 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
VA Maryland Health Care System

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Complications, Diabetic Neuropathies
Keywords
Autonomic Neuropathy, diabetes, balance control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Muscle, Balance, and aerobic exercise
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Muscle power
Intervention Type
Other
Intervention Name(s)
balance perturbation
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Primary Outcome Measure Information:
Title
Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months
Description
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.
Time Frame
baseline, 3 months, and 6 months
Title
Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months
Description
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.
Time Frame
baseline, 3 months, and 6 months
Title
Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months
Description
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.
Time Frame
baseline, 3 months, and 6 months
Title
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
Description
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.
Time Frame
baseline, 3 months, and 6 months
Secondary Outcome Measure Information:
Title
Change in clinical balance as measured by the Four Square Step Test
Description
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.
Time Frame
baseline, 3 months, and 6 months
Title
Change in mobility as measured by the modified physical performance test
Description
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.
Time Frame
baseline, 3 months, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odessa Addison, PhD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1082
Country
United States
Facility Name
VA Maryland Health Care System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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