Enhance Balance and Mobility in People With Type 2 Diabetic Peripheral Neuropathy (DPN)
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|ClinicalTrials.gov Identifier: NCT02541838|
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : January 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Complications Diabetic Neuropathies||Other: Muscle power Other: balance perturbation Other: aerobic exercise||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 2016|
|Actual Primary Completion Date :||December 2017|
|Actual Study Completion Date :||December 2017|
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
- Change in Muscle size as determined with a CT Scan from baseline to 3 months and baseline to 6 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Change in clinical balance as measured by the Four Square Step Test [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02541838
|United States, Maryland|
|PTRS Research Lab|
|Baltimore, Maryland, United States, 21201|
|VA Maryland Health Care System|
|Baltimore, Maryland, United States, 21201|