NCT07075367

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

Effect of a Trunk, Hip, Knee and Ankle Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy: a Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Federal University of Piaui · Academic / Other
• Sex: All
• Age: 45 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	Proximal/distal protocol	The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle) consisting of four stages: warm-up, strengthening, sensorimotor training and relaxation.
OTHER	Distal protocol	The control group will receive a distal exercise program available in the literature and previously tested. This will contain warm-up exercises, intrinsic foot muscle strengthening, extrinsic foot-ankle muscle strengthening, and functional exercises.

Timeline

• Start date: 2026-01-10
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2025-07-20
• Last updated: 2025-10-02