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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proximal/distal protocol | Experimental | The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle). |
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| Distal protocol | Active Comparator | The control group will receive a distal exercise program (ankle and foot) available in the literature and previously tested. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vinicius Saura Cardoso | Contact | +55 86 99984-2919 | vscfisio@ufdpar.edu.br |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Blinding will be single-blind, so the outcome evaluator will not be aware of the allocation of participants to the groups.
| 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. |
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| 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. |
| Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3). |
| 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. | Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3). |
| 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. | Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3). |