Peripheral Arterial DiseaseNCT03298230
The RESPECT-PAD Trial
A study testing REmotely SuPervised Exercise Training and Supervised Exercise Training in people with Peripheral Arterial Disease and Cardiovascular Diseases, run by University of Manchester.
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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Peripheral Arterial Disease, Cardiovascular Diseases
- What is being tested?
- REmotely SuPervised Exercise Training and Supervised Exercise Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Pilot Randomised Controlled Trial of REmotely SuPervised Exercise Training for Patients With Peripheral Arterial Disease: The RESPECT-PAD Trial
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.
- Being tested
- REmotely SuPervised Exercise Training, Supervised Exercise Training
- Medical subject headings
- Peripheral Arterial Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REmotely SuPervised Exercise TrainingBehavioural
As described in the Arms section.
Supervised Exercise TrainingBehavioural
As described in the Arms section.
| Study group | Role | What they receive |
|---|---|---|
| REmotely SuPervised Exercise Training | Experimental | 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. Receives: Behavioral: REmotely SuPervised Exercise Training |
| Supervised Exercise Training | Active comparator | As per NICE guidance. 12 week, bi-weekly, one hour sessions of supervised exercise training. Receives: Behavioral: Supervised Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Claudication Distance
Measured using a G-protocol on treadmill testing
Measured: At 12 weeks
Secondary outcomes (7)
Absolute Claudication Distance
Measured using a G-protocol on treadmill testing
Measured: 6 months and 1 year.
Initial Claudication Distance
Measured using a G-protocol on treadmill testing
Measured: 12 weeks, 6 months and one year
Health-related Quality of Line
Measured using the Medical Outcomes SF36v2 Questionnaire
Measured: 12 weeks, 6 months and one year
Cardiovascular Risk Factors
Measured by calculating change in waist circumference and BMI
Measured: 12 weeks, 6 months and one year
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
Measured: 12 weeks, 6 months and one year
Habitual physical activity levels
As measured by the physical activity scale for the elderly questionnaire.
Measured: 12 weeks, 6 months and one year
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
Measured: 12 weeks, 6 months and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study startNov 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles McCollum, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03298230
- Sponsor's protocol ID
- 224506
- Status last verified
- Oct 2018
- First submitted
- 21 Sep 2017
- Last updated
- 16 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Trial of REmotely SuPervised Exercise Training for Patients With Peripheral Arterial Disease: The RESPECT-PAD Trial
- ClinicalTrials.gov ID
- NCT03298230
- Acronym / sponsor ID
- 224506
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REmotely SuPervised Exercise Training | Experimental | Behavioral: REmotely SuPervised Exercise Training12- 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. |
| Supervised Exercise Training | Active comparator | Behavioral: Supervised Exercise TrainingAs per NICE guidance. 12 week, bi-weekly, one hour sessions of supervised exercise training. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REmotely SuPervised Exercise TrainingAs described in the Arms section. | Behavioural | REmotely SuPervised Exercise Training |
| Supervised Exercise TrainingAs described in the Arms section. | Behavioural | Supervised Exercise Training |
Primary outcome
Absolute Claudication Distance
Time frame: At 12 weeks
Measured using a G-protocol on treadmill testing
7 secondary outcomes
Absolute Claudication Distance
Time frame: 6 months and 1 year.
Initial Claudication Distance
Time frame: 12 weeks, 6 months and one year
Health-related Quality of Line
Time frame: 12 weeks, 6 months and one year
Cardiovascular Risk Factors
Time frame: 12 weeks, 6 months and one year
Cost
Time frame: 12 weeks, 6 months and one year
Habitual physical activity levels
Time frame: 12 weeks, 6 months and one year
Adherence
Time frame: 12 weeks, 6 months and one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing REmotely SuPervised Exercise Training and Supervised Exercise Training in people with Peripheral Arterial Disease and Cardiovascular Diseases, run by University of Manchester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adam Haque (01612915848, adam.haque@manchester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Claudication Distance (time frame: At 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2018.