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Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial

Patricia M. Kluding, J. Robinson Singleton, Mamatha Pasnoor, Mazen M. Dimachkie, Richard J. Barohn, A. Gordon Smith, Robin L. Marcus
DOI: 10.2522/ptj.20160200 Published 31 August 2016
Patricia M. Kluding
P.M. Kluding, PT, PhD, Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, 3901 Rainbow, MS 3051, Kansas City, KS 66160 (USA).
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  • For correspondence: pkluding@kumc.edu
J. Robinson Singleton
J.R. Singleton, MD, Department of Neurology, University of Utah, Salt Lake City, Utah.
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Mamatha Pasnoor
M. Pasnoor, MD, Department of Neurology, University of Kansas Medical Center.
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Mazen M. Dimachkie
M.M. Dimachkie, MD, Department of Neurology, University of Kansas Medical Center.
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Richard J. Barohn
R.J. Barohn, MD, Department of Neurology, University of Kansas Medical Center.
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A. Gordon Smith
A.G. Smith, MD, Department of Neurology, University of Utah.
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Robin L. Marcus
R.L. Marcus, PT, PhD, Department of Physical Therapy and Athletic Training, University of Utah.
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Abstract

Background Half of all patients with diabetes develop diabetic peripheral neuropathy (DPN), a complication leading to reduced mobility and quality of life. Although there are no proven pharmacologic approaches to reduce DPN risk or slow its progression, evidence suggests that physical activity may improve symptoms and enhance peripheral nerve regeneration.

Objective The aim of the study will be to determine the impact of an intense lifestyle intervention on neuropathy progression and quality of life in individuals with DPN.

Design The study will be a randomized controlled trial.

Setting The study will be conducted at 2 academic medical centers.

Participants The participants will be 140 individuals with type 2 diabetes and mild to moderate DPN.

Intervention The intervention group will receive 18 months of supervised exercise training, actigraphy-based counseling to reduce sedentary behavior, and individualized dietary counseling. Control group participants will receive diet and activity counseling at baseline and at 9 months.

Measurements The primary outcomes are neuropathy progression as measured by intraepidermal nerve fiber density in a distal thigh skin biopsy and the Norfolk Quality of Life–Diabetic Neuropathy score. Secondary outcomes include pain, gait, balance, and mobility measures.

Limitations Due to the combined intervention approach, this protocol will not be able to determine which intervention components influence outcomes. There also may be difficulty with participant attrition during the 18-month study intervention.

Conclusions The Activity for Diabetic Polyneuropathy (ADAPT) protocol resulted from a collaboration between physical therapists and neurologist researchers that includes as primary outcomes both a quality-of-life measure (NQOL-DN) and a physiologic biomarker (IENFD). It has the potential to demonstrate that an intensive lifestyle intervention may be a sustainable, clinically effective approach for people with DPN that improves patient outcomes and can have an immediate impact on patient care and future clinical trials.

  • Received April 27, 2016.
  • Accepted July 6, 2016.
  • © 2016 American Physical Therapy Association
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Vol 96 Issue 12 Table of Contents
Physical Therapy: 96 (12)

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  • myMoves Program: Feasibility and Acceptability Study of a Remotely Delivered Self-Management Program for Increasing Physical Activity Among Adults With Acquired Brain Injury Living in the Community
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Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial
Patricia M. Kluding, J. Robinson Singleton, Mamatha Pasnoor, Mazen M. Dimachkie, Richard J. Barohn, A. Gordon Smith, Robin L. Marcus
Physical Therapy Aug 2016, DOI: 10.2522/ptj.20160200

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Activity for Diabetic Polyneuropathy (ADAPT): Study Design and Protocol for a 2-Site Randomized Controlled Trial
Patricia M. Kluding, J. Robinson Singleton, Mamatha Pasnoor, Mazen M. Dimachkie, Richard J. Barohn, A. Gordon Smith, Robin L. Marcus
Physical Therapy Aug 2016, DOI: 10.2522/ptj.20160200
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Subjects

  • Protocols
  • Intervention
    • Therapeutic Exercise
  • Neurology/Neuromuscular System
    • Neurology/Neuromuscular System: Other
  • Diabetes

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