Improving Autonomic Function and Balance in Diabetic Neuropathy
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 80
Summary
- Conditions
- Diabetes
- Impaired Glucose Tolerance
- Neuropathy
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 80 years
- Gender
- Both males and females
Description
Study on hold due to COVID-19 In this proposed study, investigators will determine if an intense, individually tailored, carefully monitored, Diet, Physical Activity and Balance Enhancement Program (DPAEP) can improve autonomic function and balance and other measures of autonomic and balance control...
Study on hold due to COVID-19 In this proposed study, investigators will determine if an intense, individually tailored, carefully monitored, Diet, Physical Activity and Balance Enhancement Program (DPAEP) can improve autonomic function and balance and other measures of autonomic and balance control. In contrast, the primary and secondary and other efficacy measures will be compared in standard care controls (SC) who will receive general diet and physical activity information. The "Improving Autonomic Function and Balance in Diabetic Neuropathy" study is a single blinded, randomized study to determine if an intensive diet and exercise program improves autonomic function and balance. Following baseline testing, participants are randomized to either DPAEP or SC groups. DPAEP participants will receive an intensive physical activity enhancement program with a focus on aerobic activity and a balance program.
Tracking Information
- NCT #
- NCT01864460
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: James W Russell, MD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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