Activity for Diabetic Polyneuropathy
ADAPT
2 other identifiers
interventional
140
1 country
2
Brief Summary
The proposed study will randomize participants with diabetic peripheral neuropathy into two groups. One group of participants will receive standard-of-care counseling while the other group will undergo supervised exercise and counseling to increase physical activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 19, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMay 18, 2020
May 1, 2020
6.4 years
January 9, 2015
May 14, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Intraepidermal Nerve Fiber Density (IENFD)
Baseline, 9 months, and 18 months
Change in Quality of Life (NQOL-DN) Questionnaire Results
Baseline, 9 months, and 18 months
Study Arms (2)
Standard Care Counseling
EXPERIMENTALParticipants 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.
Supervised Exercise and Counseling
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- T2D defined by ADA criteria.
- Peripheral neuropathy based on the Toronto Diabetic Neuropathy Expert Group consensus criteria for "Confirmed diabetic sensorimotor peripheral neuropathy".
- Moderate DPN severity with a UENS of 2-18.
- Age between 30 and 75.
- Under the care of an identified Primary Care Physician (PCP).
You may not qualify if:
- Any alternative cause for peripheral neuropathy. The following tests must have been found normal within the last 12 months or will be performed pre-randomization: vitamin B12, serum protein electrophoresis and immunofixation. ANA and TSH may be obtained if clinically indicated and not available from clinical records.
- Family history of a non-diabetic neuropathy in a first-degree relative.
- Severe or longstanding neuropathy: UENS \> 18 or history of foot ulceration or amputation.
- Participants taking Coumadin or oral factor X or thrombin inhibitor therapy will be considered on an individual basis by the site investigator.
- Severe edema, dermatologic or lower extremity condition that would increase risk of skin biopsy.
- A serious medical condition that might shorten life span or prevent exercise.
- Subjects with obesity or hypertension considered in a dangerous range (BMI\> 45, systolic BP \>170, or diastolic BP \>110) and those who fail a medically supervised graded maximal stress test will be excluded from the study for safety reasons.
- An inability to understand or cooperate with the procedures of the study
- Females who are pregnant at screening or actively plan to become pregnant during the study period, because of the marked changes in metabolism anticipated during pregnancy.
- If ,in the investigators assessment, that participation in the study would be limited by a person's weight, size, or other physical condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Virginia Commonwealth Universitylead
- University of Kansascollaborator
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)collaborator
- University of Utahcollaborator
Study Sites (2)
University of Kansas
Kansas City, Kansas, 66160, United States
University of Utah School of Medicine
Salt Lake City, Utah, 84121, United States
Related Publications (1)
Kluding PM, Singleton JR, Pasnoor M, Dimachkie MM, Barohn RJ, Smith AG, Marcus RL. Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial. Phys Ther. 2017 Jan 1;97(1):20-31. doi: 10.2522/ptj.20160200.
PMID: 27417167DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
A. Gordon Smith, MD
Virginia Commonwealth University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 19, 2015
Study Start
November 1, 2015
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
May 18, 2020
Record last verified: 2020-05