Effect of an Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proximal/distal protocol, Distal protocol.
- Who it may be relevant to
- Registry conditions: Diabetic Peripheral Neuropathy. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of a Trunk, Hip, Knee and Ankle Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy: a Randomized Clinical Trial
Overview
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.
Interventions
- Other 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. - 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.
Primary outcome measures
- Symptoms [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
Secondary outcome measures (4)
- Quality of life assessment [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
- Fear of falling [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
- Anxiety and depression level [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
- Fall risk [Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07075367 · 6.802.243