Effect of an Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathy (DPN) is one of the most prevalent and debilitating complications of type 2 diabetes mellitus (DM2), especially affecting the distal region of the lower limbs. Such changes affect clinical aspects, such as quality of life. Several pieces of evidence point to therapeutic exercises as an effective way to minimize these deficits. This is a single-blind randomized clinical trial in which participants will be randomly assigned to two groups. The stipulated sample size was 64 participants. The experimental group will receive a distal/proximal exercise program and the control group will receive a distal exercise program available in the literature and previously tested. The intervention will last 12 weeks and will take place twice a week, with an average time of 50 minutes. Neuropathic symptoms will be considered primary outcomes. The secondary outcomes evaluated will be: capillary blood glucose, Mini-BESTest, Falls Efficacy Scale (FES), EQ-5D and HADS (depression and anxiety). This study was approved by the local research ethics committee (Opinion 6.802.243), conducted in accordance with the Declaration of Helsinki and in accordance with the CONSORT guidelines.

NCT Number	NCT07075367
Lead Sponsor	Federal University of Piaui
Conditions	Diabetic Peripheral Neuropathy
Enrollment	64 participants
Start Date	2026-01-10
Primary Completion	2027-01 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2025-10-02