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

Diabetic Neuropathies Clinical Trial

— DPN  

Official title:

High Intensity Muscle Power and Balance Perturbation Training to Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02541838
• Other study ID #: HP-00064233
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Other:
• Muscle power

• balance perturbation

• aerobic exercise

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	VA Maryland Health Care System	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	VA Maryland Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.	baseline, 3 months, and 6 months
Secondary	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.	baseline, 3 months, and 6 months