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

Sponsor

University of Maryland, Baltimore (Other)

Overall Status

Terminated

CT.gov ID

NCT02541838

Collaborator

VA Maryland Health Care System (U.S. Fed)

Enrollment

Locations

Arm

Actual Duration (Months)

1.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Complications Diabetic Neuropathies	Other: Muscle power Other: balance perturbation Other: aerobic exercise	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

N/A

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 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months [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.
Change in leg muscle strength as determined with a physiological test from baseline to 3 months and baseline to 6 months [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.
Change in cardiac autonomic neuropathy as determined by heart rate variability from baseline to 3 months and baseline to 6 months [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.
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 [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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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