Diabetic Peripheral NeuropathyNCT07075367
Effect of an Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy
A study testing Proximal/distal protocol and Distal protocol in people with Diabetic Peripheral Neuropathy, run by Federal University of Piaui.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Proximal/distal protocol and Distal protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Proximal/distal protocol, Distal protocol
- Keywords
- Diabetic peripheral neuropathy, Exercise therapy, Neuropathy symptoms, Quality of life, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proximal/distal protocolOther
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.
Distal protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Proximal/distal protocol | Experimental | The experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle). Receives: 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. Receives: Other: Distal protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
Secondary outcomes (4)
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.
Measured: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
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.
Measured: 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.
Measured: 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.
Measured: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start10 Jan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Piaui
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vinicius Saura Cardoso, Federal University of Piaui
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075367
- Sponsor's protocol ID
- 6.802.243
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07075367
- Acronym / sponsor ID
- 6.802.243
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetic peripheral neuropathy, Exercise therapy, Neuropathy symptoms, Quality of life, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Federal University of PiauiUniversity, hospital or other
- Study start
- 10 Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proximal/distal protocol | Experimental | Other: Proximal/distal protocolThe experimental group will receive a proximal/distal exercise program (trunk, hip, knee and ankle). |
| Distal protocol | Active comparator | Other: Distal protocolThe control group will receive a distal exercise program (ankle and foot) available in the literature and previously tested. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proximal/distal protocolThe 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 | Proximal/distal protocol |
| Distal protocolThe 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. | Other | Distal protocol |
Primary outcome
Symptoms
Time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).
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.
4 secondary outcomes
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Proximal/distal protocol and Distal protocol in people with Diabetic Peripheral Neuropathy, run by Federal University of Piaui.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinicius Saura Cardoso (+55 86 99984-2919, vscfisio@ufdpar.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms (time frame: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.