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The RESPECT-PAD Trial

Primary Purpose

Peripheral Arterial Disease, Cardiovascular Diseases

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

REmotely SuPervised Exercise Training

Supervised Exercise Training

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients willing and able to undertake supervised or home-based exercise training aged between 40 and 85
Positive Edinburgh questionnaire for intermittent claudication (APPENDIX H)
Proven peripheral arterial disease on diagnostic imaging
Ankle Brachial Pressure Index (ABPI) <0.9
Fontaine Classification (APPENDIX I) of PAD Stage II
Conservative management plan agreed for by Consultant Vascular Surgeon.

Exclusion Criteria:

Critical limb ischaemia
Asymptomatic peripheral arterial disease
Ambulation limited by co-morbid condition other than claudication:
Severe coronary artery disease, angina pectoris, chronic lung disease, neurological disorder, arthritis, amputation
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.
Psychiatric disorder precluding them from consenting for research and/or exercise training
Arterial reconstruction in the previous 12 months or planned within the next 6 months.
Recent or upcoming major surgery (within 3 months)
Unwilling or unable to attend/perform exercise training
Non-atherosclerotic cause of PAD
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

REmotely SuPervised Exercise Training

Supervised Exercise Training

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Absolute Claudication Distance

Measured using a G-protocol on treadmill testing

Secondary Outcome Measures

Absolute Claudication Distance

Measured using a G-protocol on treadmill testing

Initial Claudication Distance

Measured using a G-protocol on treadmill testing

Health-related Quality of Line

Measured using the Medical Outcomes SF36v2 Questionnaire

Cardiovascular Risk Factors

Measured by calculating change in waist circumference and BMI

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

Habitual physical activity levels

As measured by the physical activity scale for the elderly questionnaire.

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

Full Information

NCT ID

NCT03298230

First Posted

September 21, 2017

Last Updated

October 15, 2018

Sponsor

University of Manchester

1. Study Identification

Unique Protocol Identification Number

NCT03298230

Brief Title

The RESPECT-PAD Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 2018 (Anticipated)

Primary Completion Date

April 2019 (Anticipated)

Study Completion Date

October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Manchester

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease, Cardiovascular Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

REmotely SuPervised Exercise Training

Arm Type

Experimental

Arm Description

Arm Title

Supervised Exercise Training

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

REmotely SuPervised Exercise Training

Intervention Description

As described in the Arms section.

Intervention Type

Behavioral

Intervention Name(s)

Supervised Exercise Training

Intervention Description

As described in the Arms section.

Primary Outcome Measure Information:

Title

Absolute Claudication Distance

Description

Measured using a G-protocol on treadmill testing

Time Frame

At 12 weeks

Secondary Outcome Measure Information:

Title

Absolute Claudication Distance

Description

Measured using a G-protocol on treadmill testing

Time Frame

6 months and 1 year.

Title

Initial Claudication Distance

Description

Measured using a G-protocol on treadmill testing

Time Frame