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

NCT ID: NCT02541838

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-12-31

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.

Conditions

Diabetes Complications; Diabetic Neuropathies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Muscle power

Intervention Type: OTHER

balance perturbation

Intervention Type: OTHER

aerobic exercise

Intervention Type: OTHER

Interventions

Muscle power

Intervention Type: OTHER

balance perturbation

Intervention Type: OTHER

aerobic exercise

Intervention Type: OTHER

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Maryland Health Care System

FED

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Odessa Addison, DPT, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Odessa Addison, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

University of Maryland School of Medicine

Baltimore, Maryland, United States

VA Maryland Health Care System

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

HP-00064233

Identifier Type: -

Identifier Source: org_study_id