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.
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
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
Parallel
Proximal/distal protocol
Other interventionThe 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
Other interventionThe 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.
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.
Quality of life assessment
The EQ-5D tool will be used, consisting of five questions that assess the following aspects: mobility, personal care, usual activities, pain or discomfort, and anxiety/depression.
Fear of falling
The Falls Efficacy Scale (FES) assesses fear of falling when performing ten easy tasks related to activities of daily living. These 16 activities are scored from one to four. The FES score is the sum of the scores obtained for each item. The total score can range from 16 (no concern) to 64 (extreme concern). Therefore, the lower the score, the greater the confidence, translating into high self-efficacy.
Anxiety and depression level
Hospital Anxiety and Depression Scale. The scale consists of 14 questions that assess how patients felt during the previous week. The questions correspond to a 4-point Likert-type scale, from 0 to 3. Seven of the 14 questions assess the level of depression, and the remaining seven questions assess the level of anxiety, resulting in two subscales with scores ranging from 0 to 21. Higher scores indicate higher levels of anxiety and depression. Additionally, the following categorization can be adopted: 0 to 7 indicating no stress or depression, 8 to 10 indicating moderate levels of anxiety or depression, and \>11 indicating high levels of anxiety or depression.
Fall risk
Mini-BESTest. The test includes the domains of anticipatory postural adjustments (up to 6 points), postural responses (up to 6 points), sensory orientation (up to 6 points), and gait stability (up to 10 points). It consists of 14 items scored from 0 to 2, reaching a maximum score of 28, with higher scores corresponding to better postural balance. A private room equipped with the necessary equipment will be used for the test.
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