Effect of an Exercise Program on Motor Dysfunctions Caused by Diabetic Peripheral Neuropathy

NCT ID: NCT07100301

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2028-08-31

Brief Summary

Diabetic Peripheral Neuropathy (DPN) affects approximately half of people with Diabetes Mellitus (DM). Its repercussions on the musculoskeletal system and biomechanics mainly impact balance and locomotor function. Therefore, this study is justified by the need to design effective treatment alternatives for the motor alterations observed in people with DPN. The objective of this study will be to evaluate the effectiveness of an exercise program for the trunk, hip, knee and ankle, consisting of muscle strengthening and sensorimotor training, in the treatment of motor deficits caused by DPN. This will be a single-blind randomized clinical trial in which 64 individuals with type 2 DM and DPN will be randomly distributed between the experimental and control groups. The primary outcome will be the kinematic analysis of gait. The secondary outcomes will be: muscle strength assessed by dynamometry and the 30-second sit-to-stand test (30STS), and functional mobility through the Timed Up and Go (TUG) test. Assessments will be performed before the start of the intervention, at the end of the intervention, and at the one-month follow-up. The experimental group will perform a 12-week proximal/distal exercise program (trunk, hip, knee, and ankle). The control group will perform a distal exercise program (ankle and foot). The proposed exercise program is expected to show consistently positive results compared to the control group.

Conditions

Diabetic Peripheral Neuropathy

Study Design

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

Study Groups

Proximal-distal group

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

Group Type: EXPERIMENTAL

Proximal/distal protocol

Intervention Type: OTHER

Proximal/distal exercise program (trunk, hip, knee and ankle) consisting of four stages: warm-up, strengthening, sensorimotor training and relaxation. The intervention will last 12 weeks and will take place twice a week, with an average duration of 50-60 minutes.

Distal group

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

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. The intervention will last 12 weeks and will take place twice a week, with an average duration of 50-60 minutes.

Interventions

Proximal/distal protocol

Proximal/distal exercise program (trunk, hip, knee and ankle) consisting of four stages: warm-up, strengthening, sensorimotor training and relaxation. The intervention will last 12 weeks and will take place twice a week, with an average duration of 50-60 minutes.

Intervention Type: OTHER

Distal protocol

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. The intervention will last 12 weeks and will take place twice a week, with an average duration of 50-60 minutes.

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

79226724.9.0000.0192

Identifier Type: -

Identifier Source: org_study_id