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

NCT07075367 | Not Yet Recruiting DMC

• 1 other identifier: 6.802.243
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

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

Keywords

Diabetic peripheral neuropathy; Exercise therapy; Neuropathy symptoms; Quality of life; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Symptoms

  This consists of 15 "yes/no" questions; 13 items assess symptoms of diabetic peripheral neuropathy, one item assesses peripheral vascular disease (item 4), and one item assesses general asthenia (item 10). "Yes" answers to items 1-3, 5-6, 8-9, 11-12, and 14-15 are each awarded one point. A "no" answer to items 7 and 13 is awarded one point.

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

Secondary Outcomes (4)

• Quality of life assessment

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

• Fear of falling

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

• Anxiety and depression level

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

• Fall risk

  Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).

Study Arms (2)

Proximal/distal protocol

EXPERIMENTAL

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

Other: Proximal/distal protocol

Distal protocol

ACTIVE COMPARATOR

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

Other: Distal protocol

Interventions

Proximal/distal protocol 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.

Proximal/distal protocol

Distal protocol 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.

Distal protocol

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Piaui: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Vinicius Saura Cardoso

CONTACT

+55 86 99984-2919; vscfisio@ufdpar.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding will be single-blind, so the outcome evaluator will not be aware of the allocation of participants to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 20, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share