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Набор скоро начнётся NCT07075367

Effect of an Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy

Без фазы С лечением Diabetic Peripheral Neuropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Proximal/distal protocol, Distal protocol.
Кому может быть актуально
Состояния в реестре: Diabetic Peripheral Neuropathy. Базовые параметры: 45 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of a Trunk, Hip, Knee and Ankle Exercise Program on Clinical Aspects of People With Diabetic Peripheral Neuropathy: a Randomized Clinical Trial

Обзор

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.

Вмешательства

  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Symptoms [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
Вторичные конечные точки (4)
  • Quality of life assessment [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
  • Fear of falling [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
  • Anxiety and depression level [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]
  • Fall risk [Срок оценки: Baseline (initial assessment, AV1), 12th week (final assessment, AV2) and 16th week (follow up, AV3).]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07075367 · 6.802.243

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗