Vascular DiseaseSEICNCT02641418
Optimising the Efficacy, Patient Perception and Uptake of an Exercise Programme in People in Intermittent Claudication
A study testing Supervised exercise programme in people with Vascular Disease and Intermittent Claudication, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the major arteries supplying the lower limbs and is associated with an increased risk of mortality and morbidity. It results in restricted blood flow to the skeletal muscles causing intermittent claudication (IC). Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vascular Disease, Intermittent Claudication
- What is being tested?
- Supervised exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Oct 2017
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with IC not referred for surgery
- Community dwelling adults aged forty five or over
- Ankle brachial index ABPI less than 0.9 at rest or a drop of more than 20 after exercise testing
- Ability to walk unaided
- English speaking and able to understand simple protocol instructions
Who cannot join
- Participants who are unable to provide informed consent
- Severe cardiovascular, musculo-skeletal or pulmonary illness precluding participation in the supervised exercise
- Critical limb ischaemia
- Active treatment for cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hull Royal Infirmary
Hull, East Riding Of Yorkshire, HU3 2JZ
About this study
Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the major arteries supplying the lower limbs and is associated with an increased risk of mortality and morbidity. It results in restricted blood flow to the skeletal muscles causing intermittent claudication (IC). IC presents as cramp like pain affecting 5% of the population >50 years and is associated with a substantial reduction in walking capacity, quality of life and diminished physical function. Supervised exercise programmes have been demonstrated to improve maximum walking distances and NICE recommends group-based supervised exercise for treating patients with IC. However, there is significant variability in the impact of treatment across studies and little agreement on the underlying mechanism whereby exercise increases functional outcomes. Potential mechanisms include skeletal muscle metabolism, VO2 max, anaerobic threshold and endothelial function. Studies are needed to better understand how exercise improves outcome and in whom, so as to better refine and target the treatment.
The participation of patients with IC in exercise programmes is low. The investigators need to understand factors influencing participation so that we can improve the number of patients with IC benefiting from the programme
Read more
The research consists of two workstreams:
Workstream one
Objective:
Assess the extent to which patient baseline characteristics and candidate physiological mechanisms are associated with clinical improvement in IC patients participating in an exercise programme
Patients: Patients with documented IC referred from a Vascular Consultant. Eligible patients will be invited to participate in a 12 week supervised exercise programme.
Testing Schedule: Measurements will be recorded at baseline (prior to exercise), immediately after the completion of the exercise programme and then three months after. Measurements include:
Baseline characteristics that might predict outcome:
- Quality of life using the VascuQol questionnaire
- Clinical indicators of lower limb function: Ankle brachial pressure index (ABPI), intermittent claudication distance (ICD), Maximum walking distance (MWD).
Candidate physiological mechanisms
- Aerobic capacity (VO2 max \& AT)
- Muscular strength and endurance
- Muscle morphology (including muscle thickness, pennation angle, fascicle length and elastography)
- Endothelial function (sheer stress response as measured by flow mediated dilation)
Analysis: Regression analysis will be used to explain variation in patient maximum walking distance at 3 months. The regression will use 9 candidate measures of physiological response and 3 baseline measures to explore what mechanism and patient factors may be associated with clinical improvements. 100 patients recruited over 2 years will give a 90% power to detect an additional increase in variability in MWD explained by each candidate measure of around 5% at the a 0.05 significance level.
This research will be used to identify which types of exercise may be most influential in improving outcome and in which patients.
Workstream two
Objective:
Explore the reasons behind patients' participation, non-participation in, experience of and adherence to the exercise programme.
Study Design: An interview study of patients with IC routinely referred for supervised exercise. Three groups of patients will be invited to participate. Those who:
- Choose not to participate in the exercise programme (Group A)
- Agree to participate in the exercise programme (Group B).
- Agree to participate but discontinue after at least one session (Group C).
Semi-structured face-to-face interviews with 20 patients per group, interviews will be conducted using a topic guide to ensure consistency. The format will be flexible to allow participants to generate naturalistic data on what they consider as important and / or successful in terms of outcome. Data will be analysed thematically and managed using Nvivo software - the approach will be inductive and iterative.
This research will be used to redesign the current exercise programme to improve participation and so the impact of exercise in patients with IC.
- Conditions
- Vascular Disease, Intermittent Claudication
- Being tested
- Supervised exercise programme
- Keywords
- Exercise
- Medical subject headings
- Vascular Diseases, Intermittent Claudication, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised exercise programmeOther
supervised exercise programme
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | only 1 arm to trial Receives: Other: Supervised exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient maximum walking distance
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vascular DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hull University Teaching Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Hull
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641418
- Sponsor's protocol ID
- R1808
- Acronym
- SEIC
- Status last verified
- Jul 2019
- First submitted
- 25 Aug 2015
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Harwood AE, Totty JP, Pymer S, Huang C, Hitchman L, Carradice D, Wallace T, Smith GE, Chetter IC. Cardiovascular and musculoskeletal response to supervised exercise in patients with intermittent claudication. J Vasc Surg. 2019 Jun;69(6):1899-1908.e1. doi: 10.1016/j.jvs.2018.10.065. Epub 2018 Dec 21.
PubMed 30583899
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising the Efficacy, Patient Perception and Uptake of an Exercise Programme in People in Intermittent Claudication
- ClinicalTrials.gov ID
- NCT02641418
- Acronym / sponsor ID
- SEIC / R1808
- Conditions
- Vascular Disease, Intermittent Claudication
- Keywords
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Hull University Teaching Hospitals NHS TrustOther government
- Collaborators
- University of Hull
- Study start
- May 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Dec 2015 (estimated)
- 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.
Background: Peripheral arterial disease is a result of atherosclerotic occlusion in the major arteries supplying the lower limbs and is associated with an increased risk of mortality and morbidity. It results in restricted blood flow to the skeletal muscles causing intermittent claudication (IC). IC presents as cramp like pain affecting 5% of the population >50 years and is associated with a substantial reduction in walking capacity, quality of life and diminished physical function. Supervised exercise programmes have been demonstrated to improve maximum walking distances and NICE recommends group-based supervised exercise for treating patients with IC. However, there is significant variability in the impact of treatment across studies and little agreement on the underlying mechanism whereby exercise increases functional outcomes. Potential mechanisms include skeletal muscle metabolism, VO2 max, anaerobic threshold and endothelial function. Studies are needed to better understand how exercise improves outcome and in whom, so as to better refine and target the treatment.
The participation of patients with IC in exercise programmes is low. The investigators need to understand factors influencing participation so that we can improve the number of patients with IC benefiting from the programme
The research consists of two workstreams:
Workstream one
Objective:
Assess the extent to which patient baseline characteristics and candidate physiological mechanisms are associated with clinical improvement in IC patients participating in an exercise programme
Patients: Patients with documented IC referred from a Vascular Consultant. Eligible patients will be invited to participate in a 12 week supervised exercise programme.
Testing Schedule: Measurements will be recorded at baseline (prior to exercise), immediately after the completion of the exercise programme and then three months after. Measurements include:
Baseline characteristics that might predict outcome:
- Quality of life using the VascuQol questionnaire
- Clinical indicators of lower limb function: Ankle brachial pressure index (ABPI), intermittent claudication distance (ICD), Maximum walking distance (MWD).
Candidate physiological mechanisms
- Aerobic capacity (VO2 max \& AT)
- Muscular strength and endurance
- Muscle morphology (including muscle thickness, pennation angle, fascicle length and elastography)
- Endothelial function (sheer stress response as measured by flow mediated dilation)
Analysis: Regression analysis will be used to explain variation in patient maximum walking distance at 3 months. The regression will use 9 candidate measures of physiological response and 3 baseline measures to explore what mechanism and patient factors may be associated with clinical improvements. 100 patients recruited over 2 years will give a 90% power to detect an additional increase in variability in MWD explained by each candidate measure of around 5% at the a 0.05 significance level.
This research will be used to identify which types of exercise may be most influential in improving outcome and in which patients.
Workstream two
Objective:
Explore the reasons behind patients' participation, non-participation in, experience of and adherence to the exercise programme.
Study Design: An interview study of patients with IC routinely referred for supervised exercise. Three groups of patients will be invited to participate. Those who:
- Choose not to participate in the exercise programme (Group A)
- Agree to participate in the exercise programme (Group B).
- Agree to participate but discontinue after at least one session (Group C).
Semi-structured face-to-face interviews with 20 patients per group, interviews will be conducted using a topic guide to ensure consistency. The format will be flexible to allow participants to generate naturalistic data on what they consider as important and / or successful in terms of outcome. Data will be analysed thematically and managed using Nvivo software - the approach will be inductive and iterative.
This research will be used to redesign the current exercise programme to improve participation and so the impact of exercise in patients with IC.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Other: Supervised exercise programmeonly 1 arm to trial |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with IC not referred for surgery
- Community dwelling adults aged forty five or over
- Ankle brachial index ABPI less than 0.9 at rest or a drop of more than 20 after exercise testing
- Ability to walk unaided
- English speaking and able to understand simple protocol instructions
Key exclusion criteria (4 listed)
- Participants who are unable to provide informed consent
- Severe cardiovascular, musculo-skeletal or pulmonary illness precluding participation in the supervised exercise
- Critical limb ischaemia
- Active treatment for cancer
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 |
|---|---|---|
| Supervised exercise programmesupervised exercise programme | Other | Exercise |
Primary outcome
Patient maximum walking distance
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Results publication: PubMed 30583899Harwood AE, Totty JP, Pymer S, Huang C, Hitchman L, Carradice D, Wallace T, Smith GE, Chetter IC. Cardiovascular and musculoskeletal response to supervised exercise in patients with intermittent claudication. J Vasc Surg. 2019 Jun;69(6):1899-1908.e1. doi: 10.1016/j.jvs.2018.10.065. Epub 2018 Dec 21.
- Cardiovascular and musculoskeletal response to supervised exercise in patients with intermittent claudication.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised exercise programme in people with Vascular Disease and Intermittent Claudication, run by Hull University Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient maximum walking distance (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02641418, which also lists 1 linked publication.
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 31 Jul 2019.