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

NCT ID: NCT07075367

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-10
• Study Completion Date: 2028-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Proximal/distal protocol

The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle).

Group Type: EXPERIMENTAL

Proximal/distal protocol

Intervention Type: OTHER

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.

Distal protocol

The control group will receive a distal exercise program (ankle and foot) available in the literature and previously tested.

Group Type: ACTIVE_COMPARATOR

Distal protocol

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult individuals aged between 45 and 75 years, male or female, diagnosed with DM2;
• DPN diagnosis based on vibration sensitivity tests assessed by a 128 Hz tuning fork and tactile sensitivity measured by a 10 g monofilament
• Sedentary or irregularly active individuals (level A) according to the Physical Activity Level Classification - IPAQ
• Score of at least 5 points on the Functional Independence Measure (FIM), i.e., requires supervision, but without physical contact
• Absence of diabetic foot ulcer (DFU) for at least one month
• No amputation or at most amputation of fingers, except for the hallux

Exclusion Criteria

• Individuals involved in physical training programs simultaneously with the intervention
• History of surgical intervention in the lower limbs or spine
• Use of walking assistance devices
• Diagnosis of severe cardiovascular disorder
• Diagnosis of other neurological impairments in addition to DPN
• Presence of dementia or inability to provide consistent information
• Severe retinopathy

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Piaui

OTHER

Sponsor Role: lead

Responsible Party

Vinicius Saura Cardoso

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Vinicius Saura Cardoso

Role: CONTACT

vscfisio@ufdpar.edu.br

+55 86 99984-2919

Other Identifiers

6.802.243

Identifier Type: -

Identifier Source: org_study_id