Exercise Test and Sequential Training Strategies in PAD
Exercise Test and Sequential Training Strategies in Peripheral Arterial Disease
Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness.
In past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease.
To enhance exercise capacity in patients with PAD may involve redistribution of blood flow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood flow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood flow, and possible increased muscle capillary density and mitochondrial capacity.
Therefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Diabetic lower extremity disease, including peripheral vascular disease, peripheral neuropathy, foot ulcers, or leg amputation. Among them, peripheral arterial disease (PAD) is an important expression of systemic atherosclerosis. With the progress of the disease, impaired peripheral blood circulation will lead to many symptoms and signs, such as pain, paresthesia, and numbness.
In past studies show that regular exercise with moderate intensity may help to improve metabolism and hemodynamic characteristics of the individual. In addition, many studies have found that despite substantial organic changes in downstream tissue, exercise training can improve walking ability and aerobic capacity in patients with peripheral arterial disease.
To enhance exercise capacity in patients with PAD may involve redistribution of blood flow from vascular beds with lower O 2 exchange rates towards exercising ischemic muscles, an increase in nutritive leg muscle blood flow at the expense of regional shunting mechanisms, increased peripheral O 2 use during exercise attributable to more optimal distribution of leg blood flow, and possible increased muscle capillary density and mitochondrial capacity.
Therefore, we tried to mimic local (leg) ischemic- reperfusion by systemic exercise, or to practice remote preconditioning effect by interval occlusion of the blood vessel in the upper arm which acquired ischemic preconditioning effect, and to improve local blood flow. Furthermore, the hemagglutination performance in PAD patients may also be used as an important indicator of cardiovascular disease
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Keelung, Taiwan, 204
- Recrutamento
- Department of Physical Medicine and Rehabilitation of Keelung Chang Gung Memorial hospital
-
Contato:
- Tieh Cheng Fu, MD, PhD
- Número de telefone: 2626 886-2-24313131
- E-mail: mr5598@adm.cgmh.org.tw
-
Investigador principal:
- Tieh-Cheng Fu, MD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Ankle-brachial index <0.9
Exclusion Criteria:
1.<20 years old 2. There are other diseases or behavioral restrictions that prevent exercise training 3. Other exercise contraindications:
- unstable angina
- resting systolic blood pressure greater than 200 mmHg or diastolic blood pressure greater than 110 mmHg
- orthostatic blood pressure drop greater than 20 mmHg with symptoms
- Symptomatic severe aortic stenosis
- Acute systemic infection, accompanied by fever, body aches, or swollen lymph glands
- Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
- Uncontrolled symptomatic heart failure
- High-degree atrioventricular blocks
- Acute myocarditis or pericarditis
- Acute pulmonary embolus or pulmonary infarction
- a recent significant change in the resting electrocardiogram suggesting significant ischemia,
- recent myocardial infarction (within 2 d), or other acute cardiac events
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: usual training
exercise intensity arranged by cardiopulmonary exercise test results
|
We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
|
|
Experimental: Novel exercise training
exercise intensity monitor by near-infrared spectrometer
|
We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
physical fitness (peak oxygen consumption)
Prazo: after 36 session exercise training, up to 12 weeks
|
oxygen consumption in cc/min/kg measured by Carefusion(TM) during cardiopulmonary exercise test
|
after 36 session exercise training, up to 12 weeks
|
|
physical fitness (exercise duration)
Prazo: after 36 session exercise training, up to 12 weeks
|
exercise duration in seconds measured during cardiopulmonary exercise test
|
after 36 session exercise training, up to 12 weeks
|
|
physical fitness (walking distance)
Prazo: after 36 session exercise training, up to 12 weeks
|
walking distance in meters measured during six minutes walking test
|
after 36 session exercise training, up to 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 103-4837B
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 .
Ensaios clínicos em Doença arterial periférica
-
Mayo ClinicInscrevendo-se por conviteAnatomia da GSV para Rescue Peripheral IV AccessEstados Unidos
-
Dartmouth-Hitchcock Medical CenterDartmouth CollegeConcluídoPressão arterial | Anestesia | Linha arterialEstados Unidos
-
GE HealthcareConcluído
-
Taiwan Biophotonic CorporationConcluídoPressão arterial | Variabilidade da pressão arterialTaiwan
-
VIVUS LLCAinda não está recrutandoHipertensão arterial pulmonar | Hipertensão Arterial Pulmonar (HAP) (OMS Grupo 1 HP) | Hipertensão Arterial Pulmonar (HAP) | Hipertensão Arterial Pulmonar Grupo I da OMS | Hipertensão Arterial Pulmonar HAP
-
AHEPA University HospitalConcluídoRigidez Arterial | Monitorização Ambulatorial da Pressão ArterialGrécia
-
Shunmei MedicalAinda não está recrutandoDoença Arterial Coronária Calcificada | Doença arterial coronarianaPolônia, França, Espanha
-
BLZ Technology (Wuhan) Co.,LtdAinda não está recrutandoPressão arterial | Anestesia geral | Linha arterial | Pulsação
-
Auburn UniversityConcluídoDorme | Pressão arterial | Disfunção Endotelial | Racismo | Rigidez ArterialEstados Unidos
-
Unity Health TorontoConcluídoRigidez Arterial, Pressão ArterialCanadá