The RESPECT-PAD Trial

Cardiovascular Diseases Clinical Trial

Official title:

A Pilot Randomised Controlled Trial of REmotely SuPervised Exercise Training for Patients With Peripheral Arterial Disease: The RESPECT-PAD Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03298230
• Other study ID #: 224506
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2018
• Est. completion date: October 2019

Study information

• Verified date: October 2018
• Source: University of Manchester
• Contact: Adam Haque
• Phone: 01612915848
• Email: adam.haque[@]manchester.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Behavioral:
• REmotely SuPervised Exercise Training
As described in the Arms section.
• Supervised Exercise Training
As described in the Arms section.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Manchester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Claudication Distance	Measured using a G-protocol on treadmill testing	At 12 weeks
Secondary	Absolute Claudication Distance	Measured using a G-protocol on treadmill testing	6 months and 1 year.
Secondary	Initial Claudication Distance	Measured using a G-protocol on treadmill testing	12 weeks, 6 months and one year
Secondary	Health-related Quality of Line	Measured using the Medical Outcomes SF36v2 Questionnaire	12 weeks, 6 months and one year
Secondary	Cardiovascular Risk Factors	Measured by calculating change in waist circumference and BMI	12 weeks, 6 months and one year
Secondary	Cost	Measured by the cost of the interventions in each group, including resource and staffing costs. Also includes any unplanned admissions and procedures carried out due to a complication of the disease of interest	12 weeks, 6 months and one year
Secondary	Habitual physical activity levels	As measured by the physical activity scale for the elderly questionnaire.	12 weeks, 6 months and one year
Secondary	Adherence	As measured by using the amount of exercise in minutes performed over the 12 weeks, divided by the number of minutes of exercise prescribed x100	12 weeks, 6 months and one year