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Effects of a heart training protocol associated with LED light therapy on signs and symptoms, performance and functionality of people with diabetes and nerve involvement

Effects of a Cardiovascular Rehabilitation Protocol associated with Photobiomodulation on signs and symptoms, performance and functionality of individuals with Diabetic Neuropathy – a Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9tmdkh4
Enrollment
Unknown
Registered
2024-11-11
Start date
2024-08-05
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Neuropathies

Interventions

This is a randomized controlled clinical trial double-blind conducted based on the evaluation and training of a cardiovascular rehabilitation (CVR) with placebo or associated with photobiomodulation b
2) simulation of LED therapy (LED OFF mode) associated with cardiovascular rehabilitation. A block randomization will be performed by an independent collaborator using the Clinical Trial Randomization
E02.594.540
E02.760.169.063.500.387

Sponsors

Departamento de Fisioterapia - Universidade Federal do Ceará
Lead Sponsor
Hospital Universitário Walter Cantídio
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals aged 18 years or older; both sexes; who have a diagnosis of Diabetes Mellitus (type 1 or type 2) confirmed by a doctor (fasting plasma glucose higher or equal 126mg/dl and/or glycated hemoglobin higher or equal 6.5%); presence of diabetic peripheral neuropathy confirmed in the evaluation

Exclusion criteria

Exclusion criteria: Individuals with neuropathy of other etiologies; severe chronic kidney disease; severe diabetic retinopathy; presence of unhealed ulcers in the lower limbs; pregnant women or those intending to become pregnant; and individuals with contraindications for performing physical exercises or with performance limitations that make it impossible to conduct the assessment and training

Design outcomes

Primary

MeasureTime frame
It is expected that there will be an improvement in the signs and symptoms of neuropathy, as assessed by the Visual Analogue Pain Scale (VAS) and the Symptom Scale and Neuropathic Impairment Scale ;It is expected to find an improvement in functional performance to be evaluated using the 6-minute Walk Test; Short Physical Performance Battery and 1 Repetition Maximum Test;It is expected to find improvement in functioning assessed through the World Health Disability Assessment Schedule questionnaire

Secondary

MeasureTime frame
To assess whether there is a change in the vascular function of the lower limbs, assessed using the Ankle-Brachial Index ;To assess whether there are changes in blood glucose, cholesterol and reactive oxygen species levels, as verified by blood collection;It is expected to find an improvement in the attitude towards coping with DM, assessed through the Diabetes Attitude Questionnaire;t is expected to find an improvement in quality of life assessed through the 12-Item Short-Form Health Survey questionnaire

Countries

Brazil

Contacts

Public ContactEmanuel Santos

Departamento de Fisioterapia - Universidade Federal do Ceará

emanueldss1@gmail.com+55(85)992692366

Outcome results

None listed

Source: REBEC (via WHO ICTRP)