Claudication, IntermittentRESET2NCT04925219
REmotely Supervised Exercise Therapy Trial 2
A study testing Remotely supervised exercise programme and Self-directed exercise in people with Claudication, Intermittent and Peripheral Arterial Disease, run by Mid and South Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the National Institute for Health and Clinical Excellence and the European Society for Vascular Surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Claudication, Intermittent, Peripheral Arterial Disease
- What is being tested?
- Remotely supervised exercise programme and Self-directed exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2021to Dec 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arterial claudication with ABPI <0.9 or post-treadmill pressure drop of >20mmHg
- Able to walk 50 metres unaided
- Willing to try and give up smoking
- Willing to take antiplatelet, rivaroxaban and statin
- Has a smartphone or pedometer or watch
- Has an email account
- Adult > 18 years old
- Able to give informed consent
Who cannot join
- Nocturnal foot pain or tissue loss
- Use of walking stick, frame or wheelchair
- Severe COPD or heart failure or arthritis
- Home oxygen
- Major amputation and non-limb wearer
- Severe hearing or visual impairment
Show all 10Show fewer
- Prior failed exercise regime
- Prior falls
- Cognitive impairment
- Unable to work due to severity of claudication
Trial locations and contacts
1 site in 1 country.
Ashley Solieri contact
United Kingdom1 site, 1 recruiting
- Recruiting
Mid and South Essex Hospitals NHS Foundation Trust
Basildon, Essex, SS16 5NL
Ashley Solieri, Ashley.solieri@btuh.nhs.uk
Carol Alves, carol.alves@btuh.nhs.uk
About this study
Official title: Remotely Supervised Exercise Versus Self-Directed Exercise: Phase II Safety and Efficacy Study
Supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the National Institute for Health and Clinical Excellence and the European Society for Vascular Surgery. However 2/3 of British trusts cannot implement this due to gym availability, costs, travel time and the requirement for social distancing.
During the COVID-19 lockdown the investigators successfully performed a feasibility study for remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist.
RESET2 aims to compare the benefits of and adherence to remotely supervised exercise with self-directed exercise to absolute walking distance.
Read the detailed description
Design A single centre, pilot, randomised controlled trial at Mid and South Essex Hospitals Foundation Trust. The study is unfunded and sponsored by Mid and South Essex Hospitals National Health Service Trust.
Sample size This is a pilot randomised controlled trial to generate a sample size calculation for a larger trial.
Based on the feasibility data from RESET1 and the published results of supervised exercise, the expected benefit of remotely supervised exercise is about 180 metres extra walking distance, with a standard deviation of 150m in both groups.
With alpha=0.05 (5% false positive rate) and beta=0.1 (90% power), 16 patients in each arm are required to demonstrate a mean difference in the primary endpoint of 180 metres, using a 2 sided t-test (MedCalc statistical software, Belgium).
The sample size will be 20+20 patients from Mid and South Essex Trust vascular outpatient clinics.
Follow up There will be 3 assessment visits: baseline, 3 months and 6 months performed with a study clinician.
The primary endpoint will be measured blind to treatment allocation by asking the patient to walk along a flat, hospital corridor until they need to stop due to leg pain. This will be measured at 0, 3 and 6 months.
The secondary endpoint will be through patient questionnaires and scored by an independent observer at baseline, 3 and 6 months.
Ankle-brachial pressure index will be measured by an independent vascular scientist at the start and end of the study.
Patient satisfaction will be measured at 3 months using a self-reported questionnaire.
Adherence to exercise will be measured through submission of walking logs at 1, 2 and 3 months.
- Being tested
- Remotely supervised exercise programme, Self-directed exercise
- Medical subject headings
- Intermittent Claudication, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remotely supervised exercise programmeBehavioural
Electronic walking log Fortnightly video/telephone calls with physiotherapist
Self-directed exerciseBehavioural
Electronic walking log and instructions to exercise 4 times per week.
| Study group | Role | What they receive |
|---|---|---|
| Remotely supervised exercise | Experimental | Best medical therapy including aspirin 75mg od + rivaroxaban 2.5mg bd (if not tolerated clopidogrel 75mg od), atorvastatin 80mg and smoking cessation referral as per NICE guideline for PAD.
Intervention = electronic walking log and fortnightly video/telephone call with physiotherapist for 3 months. Receives: Behavioral: Remotely supervised exercise programme |
| Self-directed exercise | Active comparator | Best medical therapy including aspirin 75mg od + rivaroxaban 2.5mg bd (if not tolerated clopidogrel 75mg od), atorvastatin 80mg and smoking cessation referral as per NICE guideline for PAD.
Control = electronic walking log and instructions to exercise 4 times per week for 3 months Receives: Behavioral: Self-directed exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in absolute walking distance
Indoor flat surface walking distance until leg pain stops patient walking.
Measured: 3 and 6 months post randomisation
Secondary outcomes (4)
Change in disease specific quality of life
Intermittent Claudication Questionnaire (0 best - 100 worst)
Measured: 3 and 6 months post randomisation
Unplanned revascularisation
Any endovascular, open or hybrid revascularisation during follow up
Measured: 6 months
Patient satisfaction
Patient satisfaction questionnaire (1 would never recommend - 5 would strongly recommend)
Measured: 3 months
Adherence
Adherence with 2 hours exercise per week (judged via submitted walking logs)
Measured: 1, 2 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start1 Jun 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Claudication, IntermittentStudies 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
- Parallel groups
- Model description
- Pilot 2 arm RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mid and South Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ankur Thapar, PhD, Principal investigator, Mid and South Essex Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925219
- Sponsor's protocol ID
- 2987694
- Acronym
- RESET2
- Status last verified
- Jan 2024
- First submitted
- 24 Mar 2021
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The full data set will be made available to other researchers upon publication.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Supervised Exercise Versus Self-Directed Exercise: Phase II Safety and Efficacy Study
- ClinicalTrials.gov ID
- NCT04925219
- Acronym / sponsor ID
- RESET2 / 2987694
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mid and South Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Jun 2021 (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.
Supervised exercise for intermittent claudication is a first line therapy for peripheral arterial disease, as recommended by the National Institute for Health and Clinical Excellence and the European Society for Vascular Surgery. However 2/3 of British trusts cannot implement this due to gym availability, costs, travel time and the requirement for social distancing.
During the COVID-19 lockdown the investigators successfully performed a feasibility study for remotely supervised exercise using an electronic walking log and fortnightly video calls with a physiotherapist.
RESET2 aims to compare the benefits of and adherence to remotely supervised exercise with self-directed exercise to absolute walking distance.
Detailed description
Design A single centre, pilot, randomised controlled trial at Mid and South Essex Hospitals Foundation Trust. The study is unfunded and sponsored by Mid and South Essex Hospitals National Health Service Trust.
Sample size This is a pilot randomised controlled trial to generate a sample size calculation for a larger trial.
Based on the feasibility data from RESET1 and the published results of supervised exercise, the expected benefit of remotely supervised exercise is about 180 metres extra walking distance, with a standard deviation of 150m in both groups.
With alpha=0.05 (5% false positive rate) and beta=0.1 (90% power), 16 patients in each arm are required to demonstrate a mean difference in the primary endpoint of 180 metres, using a 2 sided t-test (MedCalc statistical software, Belgium).
The sample size will be 20+20 patients from Mid and South Essex Trust vascular outpatient clinics.
Follow up There will be 3 assessment visits: baseline, 3 months and 6 months performed with a study clinician.
The primary endpoint will be measured blind to treatment allocation by asking the patient to walk along a flat, hospital corridor until they need to stop due to leg pain. This will be measured at 0, 3 and 6 months.
The secondary endpoint will be through patient questionnaires and scored by an independent observer at baseline, 3 and 6 months.
Ankle-brachial pressure index will be measured by an independent vascular scientist at the start and end of the study.
Patient satisfaction will be measured at 3 months using a self-reported questionnaire.
Adherence to exercise will be measured through submission of walking logs at 1, 2 and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot 2 arm RCT
| Arm | Type | Receives |
|---|---|---|
| Remotely supervised exercise | Experimental | Behavioral: Remotely supervised exercise programmeBest medical therapy including aspirin 75mg od + rivaroxaban 2.5mg bd (if not tolerated clopidogrel 75mg od), atorvastatin 80mg and smoking cessation referral as per NICE guideline for PAD. Intervention = electronic walking log and fortnightly video/telephone call with physiotherapist for 3 months. |
| Self-directed exercise | Active comparator | Behavioral: Self-directed exerciseBest medical therapy including aspirin 75mg od + rivaroxaban 2.5mg bd (if not tolerated clopidogrel 75mg od), atorvastatin 80mg and smoking cessation referral as per NICE guideline for PAD. Control = electronic walking log and instructions to exercise 4 times per week for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Arterial claudication with ABPI <0.9 or post-treadmill pressure drop of >20mmHg
- Able to walk 50 metres unaided
- Willing to try and give up smoking
- Willing to take antiplatelet, rivaroxaban and statin
- Has a smartphone or pedometer or watch
Key exclusion criteria (10 listed)
- Nocturnal foot pain or tissue loss
- Use of walking stick, frame or wheelchair
- Severe COPD or heart failure or arthritis
- Home oxygen
- Major amputation and non-limb wearer
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 programmeElectronic walking log Fortnightly video/telephone calls with physiotherapist | Behavioural | Remotely supervised exercise |
| Self-directed exerciseElectronic walking log and instructions to exercise 4 times per week. | Behavioural | Self-directed exercise |
Primary outcome
Change in absolute walking distance
Time frame: 3 and 6 months post randomisation
Indoor flat surface walking distance until leg pain stops patient walking.
4 secondary outcomes
Change in disease specific quality of life
Time frame: 3 and 6 months post randomisation
Unplanned revascularisation
Time frame: 6 months
Patient satisfaction
Time frame: 3 months
Adherence
Time frame: 1, 2 and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Yes. The full data set will be made available to other researchers upon publication.
Related trials for Claudication, Intermittent
Active, not recruitingPhase 4
Ramipril Treatment of Claudication: Oxidative Damage and Muscle Fibrosis
Peripheral Arterial Disease
Recruiting
EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
RecruitingPhase 3
Improving Mobility After Revascularization in Peripheral Artery Disease
Peripheral Artery Disease, Intermittent Claudication
Recruiting
Passive Calf Stretching Therapy in Peripheral Artery Disease
Peripheral Artery Disease, Claudication, Intermittent
Recruiting
Community-based Exercise Following Revascularization for PAD
Peripheral Artery Disease
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.
Ashley Solieri contact
Ankur Thapar, PhD principal investigator
Mid and South Essex Hospitals NHS Foundation 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 Remotely supervised exercise programme and Self-directed exercise in people with Claudication, Intermittent and Peripheral Arterial Disease, run by Mid and South Essex NHS Foundation 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 8 inclusion and 10 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 12 Jan 2024. 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 Ankur Thapar, PhD (012685249000, a.thapar@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in absolute walking distance (time frame: 3 and 6 months post randomisation). 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 12 Jan 2024.