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

NCT02541838 | Terminated DMC

• 1 other identifier: HP-00064233
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Complications; Diabetic Neuropathies

Keywords

Autonomic Neuropathy; diabetes; balance control

Outcome Measures

Primary Outcomes (4)

• 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.

  baseline, 3 months, and 6 months

• 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.

  baseline, 3 months, and 6 months

• 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.

  baseline, 3 months, and 6 months

• 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.

  baseline, 3 months, and 6 months

Secondary Outcomes (2)

• Change in clinical balance as measured by the Four Square Step Test

  baseline, 3 months, and 6 months

• Change in mobility as measured by the modified physical performance test

  baseline, 3 months, and 6 months

Study Arms (1)

Muscle, Balance, and aerobic exercise

EXPERIMENTAL

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

Interventions

Muscle power OTHER

Muscle, Balance, and aerobic exercise

balance perturbation OTHER

Muscle, Balance, and aerobic exercise

aerobic exercise OTHER

Muscle, Balance, and aerobic exercise

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• VA Maryland Health Care System: collaborator

Study Sites (2)

University of Maryland School of Medicine

Baltimore, Maryland, 21201-1082, United States

Location

VA Maryland Health Care System

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Diabetes Complications; Diabetic Neuropathies; Diabetes Mellitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Odessa Addison, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 4, 2015
• Study Start: May 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)