- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07756073
Buerger's Exercises and Proprioceptive Drills on Postural Stability and Foot Perfusion in Elderly Patients With Chemotherapy
Combined Effect of Buerger's Exercises and Proprioceptive Drills on Postural Stability and Foot Perfusion in Elderly Patients With Chemotherapy-Induced Peripheral Neuropathy Randomized Controlled Trial
Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting side effect of neurotoxic chemotherapy agents, characterized by sensory loss, impaired proprioception, and muscle weakness, predominantly affecting the lower limbs. These impairments significantly contribute to postural instability and increase fall risk in elderly patients. Additionally, CIPN-associated microvascular changes can compromise peripheral circulation, further exacerbating neuromotor dysfunction and balance deficits.
While pharmacological options for CIPN are limited and often inadequate, exercise-based interventions have shown promise in mitigating functional impairments. Buerger's exercises, a vascular stimulation technique, are known to enhance peripheral blood flow, whereas proprioceptive drills can improve neuromuscular coordination and postural control. However, their combined effect on both postural stability and foot perfusion in elderly patients with CIPN has not been systematically studied.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Aim of the Study To investigate the combined effect of Buerger's exercises and proprioceptive drills on postural stability and foot perfusion in elderly patients with chemotherapy-induced peripheral neuropathy.
Objectives
Primary Objectives:
- To evaluate the effect of combined Buerger's exercises and proprioceptive drills on postural stability.
- To assess their effect on foot perfusion.
Secondary Objectives:
• To assess changes in balance confidence, functional mobility, and fall incidence.
________________________________________
Hypotheses
- H1: The combined intervention will significantly improve postural stability compared to standard care.
- H2: The combined intervention will significantly enhance foot perfusion compared to standard care.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: ibrahim abuzaid, Assistant professor
- Número de telefone: 01006512160
- E-mail: ibrahim_ismail_2011@svu.edu.eg
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Aged 65 years or older
- Diagnosed with CIPN for at least 3 months
- Demonstrating impaired postural stability (BBS ≤ 48 or ≥2 falls in the past year)
- Medically cleared for exercise
- Cognitively intact (MMSE ≥ 24)
- Willing and able to give consent
Exclusion Criteria:
- Severe peripheral arterial disease (ABI < 0.5)
- Severe postural hypotension or positional syncope
- Recent orthopedic procedures or fractures (past 6 months)
- Vestibular or cerebellar disorders
- Uncontrolled systemic diseases
- Cognitive impairment (MMSE < 24)
- Concurrent participation in another structured balance or vascular program
- Lower limb ulcers or active infection
- Severe visual impairment
- Intolerance to positional exercises
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention Group
Intervention Group (35 participants) will receive Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:
|
Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:
|
|
Comparador Ativo: Control Group
Control Group (35 participants) will receive Standard care with educational leaflets and physical activity advice.
|
Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Postural Stability Foot Perfusion
Prazo: Week 8
|
.Postural Stability: Overall Stability Index (OSI) via Biodex Balance System SD Foot Perfusion: Laser Doppler Flowmetry (LDF)
|
Week 8
|
|
Pain scale (VAS) Quality of Life Index (QLI) - SCI Version
Prazo: 8 weeks
|
Pain scale (VAS) The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Quality of Life Index (QLI) - SCI Version Comprised of 4 domains:
|
8 weeks
|
|
Weight Height Body mass index
Prazo: 8 weeks
|
Weight in kg, height in meter and body mass index in kg/m2
|
8 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Secondary Outcomes
Prazo: 8 weeks
|
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Chang CF, Chang CC, Hwang SL, Chen MY. Effects of Buerger Exercise Combined Health-Promoting Program on Peripheral Neurovasculopathy Among Community Residents at High Risk for Diabetic Foot Ulceration. Worldviews Evid Based Nurs. 2015 Jun;12(3):145-53. doi: 10.1111/wvn.12091. Epub 2015 May 11.
- Thakur A, Sharma R, Sharma SK, Thakur K, Jelly P. Effect of buerger allen exercise on foot perfusion among patient with diabetes mellitus: A systematic review & meta-analysis. Diabetes Metab Syndr. 2022 Feb;16(2):102393. doi: 10.1016/j.dsx.2022.102393. Epub 2022 Jan 13.
Links úteis
- Background: Peripheral neuropathy and vasculopathy are important risk factors for diabetic foot ulceration (DFU). Buerger exercises for patients with arterial occlusive disease have previously been noted; however, current evidence to support this interve
- Aim: Buerger-Allen exercise includes set of activities like elevation, movement and rest of the lower extremities. This systematic review and meta-analysis aimed to assess the effectiveness of BAE on foot perfusion among patient with diabetes mellitus.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- Qena university
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .