Intermittent ClaudicationNCT01980602
Effect of Exercise on Patients With Claudication Undergoing Surgery
A study testing Supervised Exercise program in people with Intermittent Claudication and Peripheral Arterial Disease, run by University of Hull at 1 site in United Kingdom.
Trial summary
Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg? Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as easily as a healthy leg would. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intermittent Claudication, Peripheral Arterial Disease
- What is being tested?
- Supervised Exercise program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Jul 2016
- 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
- Community dwelling older adults aged 45 and over
- Diagnosis of intermittent claudication - ABPI < 0.9 with symptoms in keeping with intermittent claudication
- Undergoing surgery for claudication
- Ability to walk without assistance
- Healthy control patients who are undergoing varicose vein surgery
Who cannot join
- Participants who are unable to provide informed consent
- Severe of acute cardiovascular, musculoskeletal or pulmonary illness
- Critical limb ischaemia
- Active treatment for cancer
- Rheumatoid arthritis or any patient receiving steroids or disease modifying Antirheumatic drugs (DMARDS)
- Failure to complete a CPET
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hull Royal Infirmary
Hull, HU3 2JZ
Romesh Sarvanandan, MBBS MRCS, 01482674643, romesh1985@doctors.org.uk
Romesh Sarvanandan, MBBS MRCS
About this study
Official title: A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants
Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg?
Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as easily as a healthy leg would. This causes pain when walking (intermittent claudication), which often occurs after a reproducible distance e.g. every 50 yards. These patients have a reduction in their quality of life as they feel embarrassed in social situations e.g. walking around town requires multiple breaks, so they tend to avoid this and isolate themselves more.
Read more
One treatment for claudication is exercising until the pain comes on; which most are reluctant to do. Walking up to three times a week for an hour, can double most people's walking distances, but doesn't always. The reason why some improve with exercise and others do not remains unknown.
This project will be the first randomised controlled trial of exercise in claudicants that focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare muscle cells from a group that have exercised and group that have not. We will focus on the change in muscle cell size and function at present, and later progress to why and how this happens.
Methods: We will take measurements at the start of the study (baseline), after 6 weeks and then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking distances and blood samples. At the time of surgery, muscle from the calf will be taken from the affected leg. This will be processed at the University's biomedical science department to look at the different types of muscle fibre and how efficiently they are working.
- Being tested
- Supervised Exercise program
- Keywords
- Intermittent claudication, endothelial function, cardiopulmonary testing, inflammation, muscle architecture
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise programProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Program | Experimental | Not described Receives: Procedure: Supervised Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care
Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness
Measured: 6 weeks
Secondary outcomes (3)
Measure the changes in muscle fibre type with exercise training or standard care
Histological analysis to measure the percentage of different types of muscle fibres, and how these are affected by 6 weeks of exercise compared to standard treatment.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Measurement of endothelial function after a period or exercise therapy or standard care
To identify if 6 weeks of exercise improves the endothelial function.
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Measurement of inflammatory markers with exercise treatment or standard care
To identify whether 6 weeks of exercise therapy improves inflammatory markers
Measured: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startMar 2011
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermittent ClaudicationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Carradice, University of Hull
- Investigators
- Romesh Sarvanandan, MBBS MRCS, Principal investigator, Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980602
- Sponsor's protocol ID
- 11/YH/0210
- Status last verified
- Nov 2013
- First submitted
- 24 Sep 2013
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Analyse the Histological, Physiological and Haemorrheological Adaptations to Supervised Exercise Training in Claudicants
- ClinicalTrials.gov ID
- NCT01980602
- Acronym / sponsor ID
- 11/YH/0210
- Keywords
- Intermittent claudication, endothelial function, cardiopulmonary testing, inflammation, muscle architecture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jul 2016 (estimated)
- First posted
- 11 Nov 2013 (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.
Title: How does exercise improve the calf muscle in patients with poor blood supply to their leg?
Purpose of the project: Patients with peripheral arterial disease have a poor blood supply to their lower leg. The reduced inflow prevents the leg from utilising nutrients and oxygen as easily as a healthy leg would. This causes pain when walking (intermittent claudication), which often occurs after a reproducible distance e.g. every 50 yards. These patients have a reduction in their quality of life as they feel embarrassed in social situations e.g. walking around town requires multiple breaks, so they tend to avoid this and isolate themselves more.
One treatment for claudication is exercising until the pain comes on; which most are reluctant to do. Walking up to three times a week for an hour, can double most people's walking distances, but doesn't always. The reason why some improve with exercise and others do not remains unknown.
This project will be the first randomised controlled trial of exercise in claudicants that focuses on the adaptations that occur in the muscle at a cellular level. We wish to compare muscle cells from a group that have exercised and group that have not. We will focus on the change in muscle cell size and function at present, and later progress to why and how this happens.
Methods: We will take measurements at the start of the study (baseline), after 6 weeks and then 3, 6 and 12 months. These measurements will be of a patient's fitness, actual walking distances and blood samples. At the time of surgery, muscle from the calf will be taken from the affected leg. This will be processed at the University's biomedical science department to look at the different types of muscle fibre and how efficiently they are working.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Program | Experimental | Procedure: Supervised Exercise program |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Community dwelling older adults aged 45 and over
- Diagnosis of intermittent claudication - ABPI < 0.9 with symptoms in keeping with intermittent claudication
- Undergoing surgery for claudication
- Ability to walk without assistance
- Healthy control patients who are undergoing varicose vein surgery
Key exclusion criteria (6 listed)
- Participants who are unable to provide informed consent
- Severe of acute cardiovascular, musculoskeletal or pulmonary illness
- Critical limb ischaemia
- Active treatment for cancer
- Rheumatoid arthritis or any patient receiving steroids or disease modifying Antirheumatic drugs (DMARDS)
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 program | Procedure or surgery | Supervised Exercise Program |
Primary outcome
Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care
Time frame: 6 weeks
Patients will undergo cardiopulmonary exercise testing to assess whether a 6 week exercise programme improves the cardiovascular fitness
3 secondary outcomes
Measure the changes in muscle fibre type with exercise training or standard care
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Measurement of endothelial function after a period or exercise therapy or standard care
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Measurement of inflammatory markers with exercise treatment or standard care
Time frame: Baseline, 6 weeks, 3 months, 6 months, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2013.
Related trials for Intermittent Claudication
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EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
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Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
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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.
Romesh Sarvanandan, MBBS MRCS principal investigator
Hull York Medical School/ University of Hull/ Hull and East Yorkshire NHS Trust
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 program in people with Intermittent Claudication and Peripheral Arterial Disease, run by University of Hull 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 6 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 11 Nov 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Romesh Sarvanandan, MBBS MRCS (01482674643, romesh1985@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of cardiovascular ability as recorded by their anaerobic threshold and peak VO2 after 6 weeks of exercise training or standard care (time frame: 6 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 11 Nov 2013.