Remote Supervision for Home-Based Exercise in Peripheral Arterial Disease
REmotely SuPervised Exercise Training
+ Supervised Exercise Training
Enfermedades Oclusivas Arteriales+1
+ Arteriosclerosis
+ Enfermedades Cardiovasculares
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 2018
Fecha en la que se inscribió al primer participante.Peripheral arterial disease, a condition affecting around 25% of the UK population aged over 55, can lead to severe pain, gangrene, amputation, and even death if left untreated. It primarily affects the lower limbs, causing a symptom known as intermittent claudication, which is pain in the legs that prevents patients from walking beyond a certain distance. Current guidelines recommend Supervised Exercise as the first line of treatment for this condition. However, many institutions lack the resources and patient compliance to offer such programs. The RESPECT-PAD trial introduces a more cost-effective and resource-friendly solution: REmotely SuPervised ExerCise Training (RESPECT). This approach allows patients to exercise at home, under supervision via fitness tracker technology and an online fitness platform, with the potential to revolutionize the management of peripheral arterial disease. During the trial, participants will exercise at home using fitness tracker technology and an online fitness platform, enabling remote supervision. The study's primary goal is to measure the effectiveness of this approach in increasing the distance patients can walk without pain (claudication distance), enhancing functional ability, decreasing cardiovascular risk, and improving quality of life. The study will compare these results with those of the current first line treatment, aiming to prove that remotely supervised exercise training is not only effective but also more cost-effective.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 60 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 30 a 80 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: 1. Patients willing and able to undertake supervised or home-based exercise training aged between 40 and 85 2. Positive Edinburgh questionnaire for intermittent claudication (APPENDIX H) 3. Proven peripheral arterial disease on diagnostic imaging 4. Ankle Brachial Pressure Index (ABPI) \<0.9 5. Fontaine Classification (APPENDIX I) of PAD Stage II 6. Conservative management plan agreed for by Consultant Vascular Surgeon. Exclusion Criteria: 1. Critical limb ischaemia 2. Asymptomatic peripheral arterial disease 3. Ambulation limited by co-morbid condition other than claudication: Severe coronary artery disease, angina pectoris, chronic lung disease, neurological disorder, arthritis, amputation 4. Contraindication to exercise training (AHA guidelines):71 acute MI (within 1 week), unstable angina, uncontrolled cardiac arrhythmias causing symptoms or haemodynamic compromise, active endocarditis, symptomatic severe aortic stenosis, acute pulmonary embolus, acute noncardiac disorder than may be aggravated by exercise such as infection, thyrotoxicosis, acute myocarditis, known physical disability that would preclude safe and adequate testing, known thrombosis of the lower limb, known left main stem coronary stenosis, moderate stenotic valvular heart disease, pulmonary hypertension, hypertrophic cardiomyopathy, atrio-ventricular block. 5. Psychiatric disorder precluding them from consenting for research and/or exercise training 6. Arterial reconstruction in the previous 12 months or planned within the next 6 months. 7. Recent or upcoming major surgery (within 3 months) 8. Unwilling or unable to attend/perform exercise training 9. Non-atherosclerotic cause of PAD 10. Other significant medical problems which impact on the patient's ability to complete a 12-week exercise programme, which could include: malignancy, chronic renal disease, chronic liver disease or anaemia, active substance abuse, dementia
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
Comparador ActivoObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios