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

Area of Science:

• Neurology
• Endocrinology
• Physical Therapy

Background:

• Diabetic peripheral neuropathy (DPN) affects half of all diabetes patients, reducing mobility and quality of life.
• Current pharmacologic treatments for DPN are limited, highlighting the need for alternative interventions.
• Physical activity shows promise in improving DPN symptoms and promoting nerve regeneration.

Purpose of the Study:

• To determine the impact of an intensive lifestyle intervention on DPN progression.
• To assess the effect of the intervention on the quality of life for individuals with DPN.

Main Methods:

• A randomized controlled trial involving 140 individuals with type 2 diabetes and mild to moderate DPN.
• The intervention group received 18 months of supervised exercise, sedentary behavior counseling, and dietary guidance.
• The control group received standard diet and activity counseling.

Main Results:

• Primary outcomes include neuropathy progression (intraepidermal nerve fiber density) and quality of life (Norfolk Quality of Life-Diabetic Neuropathy score).
• Secondary outcomes assess pain, gait, balance, and mobility.
• The study is designed to evaluate the efficacy of a comprehensive lifestyle intervention.

Conclusions:

• The Activity for Diabetic Polyneuropathy (ADAPT) protocol integrates quality-of-life and physiological measures.
• This intensive lifestyle intervention has the potential to be a sustainable and effective approach for DPN management.
• The findings may significantly impact patient care and inform future clinical trials for DPN.