The RESPECT-PAD Trial

NCT ID: NCT03298230

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2019-10-31

Brief Summary

Peripheral arterial disease affects around 25% of the UK population aged over 55. Left untreated it can lead to debilitating pain, gangrene, amputation and death. It most commonly affects the lower limbs and in the earlier stages of the disease patients can present with a symptom known as intermittent claudication; pain felt in the legs which stops the patient from walking past a certain distance. Current National Institute for Healthcare and Excellence (NICE) guidelines recommend Supervised Exercise as first line treatment for patients with peripheral arterial disease presenting with intermittent claudication. Supervised exercise employs behaviour changing techniques which enable the patient to modify their lifestyles, improving their claudication symptoms, quality of life and reducing their cardiovascular risk. Despite this treatment being significantly more cost-effective than often employed complex endovascular management, most institutions don't offer such programmes citing lack of resources and compliance from clinicians and patients alike.

The investigators propose a more cost-effective, resource-savvy solution in the form of REmotely SuPervised ExerCise Training (RESPECT). This allows the patient to exercise in the convenience of their own home, at a time of their choosing but still be supervised via fitness tracker technology and an online fitness platform. This randomised controlled trial will attempt to prove its' effectiveness in increasing claudication distance, improving functional ability, decreasing cardiovascular risk and improving quality of life whilst being more cost-effective than the currently recognised national first line treatment. This trial has the potential to revolutionise the management of patients with peripheral arterial disease.

Conditions

Peripheral Arterial Disease; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

REmotely SuPervised Exercise Training

12- week home based exercise programme consisting of bi-weekly, hourly sessions at the time and place of the participant's choosing. They will wear a fitness tracker which will automatically upload their exercise data to an online platform which can be monitored by the research team and used to provide additional motivation.

Group Type: EXPERIMENTAL

REmotely SuPervised Exercise Training

Intervention Type: BEHAVIORAL

As described in the Arms section.

Supervised Exercise Training

As per NICE guidance. 12 week, bi-weekly, one hour sessions of supervised exercise training.

Group Type: ACTIVE_COMPARATOR

Supervised Exercise Training

Intervention Type: BEHAVIORAL

As described in the Arms section.

Interventions

REmotely SuPervised Exercise Training

As described in the Arms section.

Intervention Type: BEHAVIORAL

Supervised Exercise Training

As described in the Arms section.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Charles McCollum

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Adam Haque

Role: CONTACT

adam.haque@manchester.ac.uk

01612915848

Other Identifiers

224506

Identifier Type: -

Identifier Source: org_study_id