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Supervised Exercise and Counseling for Diabetic Neuropathy (ADAPT Trial)

N/A
Waitlist Available
Led By A. Gordon Smith, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial will compare the effects of two different treatments for people with diabetic peripheral neuropathy.

Eligible Conditions
  • Diabetic Neuropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Group I: Supervised Exercise and CounselingExperimental Treatment1 Intervention
Participants randomized to the intervention will perform supervised aerobic, resistance and balance training twice weekly for 12 weeks, and weekly thereafter. Actigraphy-based counseling to reduce sedentary behavior will follow a similar taper. Daily text messages, "tweets", emails, and social media posts at random times during waking hours will be used to provide reminders and motivational messages. Participants will have 11 separate 7-day continuous ActivePAL training session incorporating vibrostimulatory feedback spread across the treatment period.
Group II: Standard Care CounselingExperimental Treatment1 Intervention
Participants randomized to the control group will receive diet and exercise counseling at baseline and 9 months. Participants will wear an ActivePAL for 7 days at baseline, 9 months, and 18 months without stimulation.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
710 Previous Clinical Trials
22,886,797 Total Patients Enrolled
University of KansasOTHER
150 Previous Clinical Trials
326,579 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,409 Previous Clinical Trials
4,324,769 Total Patients Enrolled
~14 spots leftby Sep 2025
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