Remote Supervision for Home-Based Exercise in Peripheral Arterial Disease
REmotely SuPervised Exercise Training
+ Supervised Exercise Training
Arterial Occlusive Diseases+4
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: November 1, 2018
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives