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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 baseline, 9 months, and 18 months
Awards & highlights

ADAPT Trial Summary

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

Eligible Conditions
  • Diabetic Neuropathy

ADAPT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 9 months, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 9 months, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Intraepidermal Nerve Fiber Density (IENFD)
Change in Quality of Life (NQOL-DN) Questionnaire Results

ADAPT 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
693 Previous Clinical Trials
22,884,779 Total Patients Enrolled
University of KansasOTHER
147 Previous Clinical Trials
325,721 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,352 Previous Clinical Trials
4,315,002 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Activity for Diabetic Polyneuropathy
2015. "Activity for Diabetic Polyneuropathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02341261.
All > Neuropathy
~15 spots leftby Apr 2025
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