Peripheral Arterial DiseaseNCT05260567
Telehealth Exercise Training in Peripheral Arterial Disease - TEXT-PAD
A study testing Exercise and Lifestyle Change in people with Peripheral Arterial Disease and Intermittent Claudication, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Peripheral arterial disease is a common, under-treated and under-researched issue. The vast majority of these patients often have multiple issues which can be improved with targeted behavioural change interventions. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Intermittent Claudication, Behavior, Health
- What is being tested?
- Exercise and Lifestyle Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Feb 2022to 8 Nov 2023
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PAD confirmed by ankle-brachial index <0.90 in one or both limbs
- Age >= 40 years
- Able to walk distance >50m
- Live in an area deemed in lowest 30% of super output area from Office of National Statistics
Who cannot join
- chronic limb threatening ischemia
- short claudication distance <50m
- severe heart disease (Grade III or IV, New York Heart Association)
- severe ischemic or haemorrhagic stroke or neurodegenerative diseases
- severe hypertension (systolic blood pressure of more than 180 mm Hg, and a diastolic
- blood pressure of more than 100 mm Hg)
Show all 12Show fewer
- uncontrolled cardiac arrhythmias (unstable angina during the previous month and
- myocardial infarction during the previous month)
- a resting heart rate of more than 120 beats per minute
- has already undergone angioplasty, bypass or other surgical intervention for PAD
- other severe comorbid conditions preventing the ability to engage in physical activity,
- inability or unwillingness to undertake the commitments of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Freeman Hospital - Newcastle upon Tyne NHS trust
Newcastle upon Tyne
About this study
Official title: A Multimodal Tele-health Behavioural Intervention in Patients With Peripheral Arterial Disease From Low Socio-economic Areas: a Feasibility and Pilot Randomized Controlled Trial With Embedded Process Evaluation
Peripheral arterial disease is a common, under-treated and under-researched issue. The vast majority of these patients often have multiple issues which can be improved with targeted behavioural change interventions. NICE has recommended that supervised exercise is the mainstay of treatment for intermittent claudication (ischaemic muscle pain on walking due to blocked and narrowed arteries). However, in the vast majority of UK hospitals, this isn't undertaken, and with the issues around group-based sessions and repeated visits to hospitals, this treatment option is not available with the coronavirus pandemic.
This is a single-centre randomised control trial in 60 patients with peripheral arterial disease attending the Freeman Hospital. Patients will be randomised to either an enhanced behavioural change intervention targeting multiple health behaviours vs a simple walking intervention. Also, some patients will be involved in focus groups to understand their experience of the intervention and whether it is feasible and acceptable, allowing changes to be made to the program.
The primary outcome will be to assess the feasibility and acceptability of the program. We will also be assessing multiple secondary outcomes including functional capacity, quality of life, sleep quality and smoking and alcohol reduction.
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Behavior, Health, Exercise Intervention
- Being tested
- Exercise and Lifestyle Change
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise and Lifestyle ChangeBehavioural
Patients will undergo to weekly phone call/videoconference for 12 weeks and discuss the behaviour change.
They also will undergo to home-based exercise training will be performed twice a week for 12 weeks via Zoom (up to 5 patients per session). Each session will be comprised of warm-up (10 min), the main part (15 to 20 min), and cooldown (5 to 10 min). The training aims to develop resistance, aerobic and functional capacity such as getting up, walking, pulling, pushing, throwing, transferring body weight or external loads. In addition, patients will be encouraged to increase their physical activity. Patients will be provided with a Fitbit device to monitor their step count and will be recommended to increase their previous week's average step count by 10%.
| Study group | Role | What they receive |
|---|---|---|
| Exercise and Lifestyle Change | Experimental | Exercise training and lifestyle change Receives: Behavioral: Exercise and Lifestyle Change |
| Standard Care | Other | Patients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline. Receives: Behavioral: Exercise and Lifestyle Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the program
Feasibility will be determined by calculating the rate of patient screening, eligibility, recruitment, retention at 12 weeks and adherence to the intervention (number of sessions attended and completed)
Measured: post 12 weeks
Acceptability of the program
Patient acceptability of the intervention and study experience more broadly will be determined through semi-structured qualitative 1-2-1 interviews and/or focus groups.
Measured: post 12 weeks
Secondary outcomes (12)
Six-minute walk test (6MWT)
Measured: pre and post-12 weeks
Walking Impairment Questionnaire (WIQ)
Measured: pre and post-12 weeks
Walking Estimated Limitation Calculated by History (WELCH) questionnaire
Measured: pre and post-12 weeks
Vascular quality of life questionnaire (VascuQoL-6)
Measured: pre and post-12 weeks
EuroQoL questionnaire (EQ-5D-5L).
Measured: pre and post-12 weeks
Short Form Dietary Questionnaire
Measured: pre and post-12 weeks
Physical activity levels (Fitbit Charge HR)
Measured: pre and post-12 weeks
Sleep
(Fitbit Charge HR)
Measured: pre and post-12 weeks
Alcohol and tobacco use
The 3-item Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and self-reported smoking habits
Measured: pre and post-12 weeks
Mental wellbeing
hospital anxiety-depression score (HADS)
Measured: pre and post-12 weeks
Patient activation
The Patient Activation Measure (PAM®)
Measured: pre and post-12 weeks
Resource utilisation
The case report forms (CRF)
Measured: pre and post-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start5 Feb 2022
- Primary completion30 Jul 2023
- Study completion8 Nov 2023
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.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Cucato, Northumbria University
- Investigators
- James Prentis, Principal investigator, Freeman Hospital - Newcastle upon Tyne NHS trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260567
- Sponsor's protocol ID
- 286735
- Status last verified
- Nov 2023
- First submitted
- 15 Feb 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Tele-health Behavioural Intervention in Patients With Peripheral Arterial Disease From Low Socio-economic Areas: a Feasibility and Pilot Randomized Controlled Trial With Embedded Process Evaluation
- ClinicalTrials.gov ID
- NCT05260567
- Acronym / sponsor ID
- 286735
- Conditions
- Peripheral Arterial Disease, Intermittent Claudication, Behavior, Health, Exercise Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 2 Mar 2022 (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 is a common, under-treated and under-researched issue. The vast majority of these patients often have multiple issues which can be improved with targeted behavioural change interventions. NICE has recommended that supervised exercise is the mainstay of treatment for intermittent claudication (ischaemic muscle pain on walking due to blocked and narrowed arteries). However, in the vast majority of UK hospitals, this isn't undertaken, and with the issues around group-based sessions and repeated visits to hospitals, this treatment option is not available with the coronavirus pandemic.
This is a single-centre randomised control trial in 60 patients with peripheral arterial disease attending the Freeman Hospital. Patients will be randomised to either an enhanced behavioural change intervention targeting multiple health behaviours vs a simple walking intervention. Also, some patients will be involved in focus groups to understand their experience of the intervention and whether it is feasible and acceptable, allowing changes to be made to the program.
The primary outcome will be to assess the feasibility and acceptability of the program. We will also be assessing multiple secondary outcomes including functional capacity, quality of life, sleep quality and smoking and alcohol reduction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise and Lifestyle Change | Experimental | Behavioral: Exercise and Lifestyle ChangeExercise training and lifestyle change |
| Standard Care | Other | Behavioral: Exercise and Lifestyle ChangePatients will also receive specific advice to perform an unsupervised walking exercise according to NICE guideline. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PAD confirmed by ankle-brachial index <0.90 in one or both limbs
- Age >= 40 years
- Able to walk distance >50m
- Live in an area deemed in lowest 30% of super output area from Office of National Statistics
Key exclusion criteria (12 listed)
- chronic limb threatening ischemia
- short claudication distance <50m
- severe heart disease (Grade III or IV, New York Heart Association)
- severe ischemic or haemorrhagic stroke or neurodegenerative diseases
- severe hypertension (systolic blood pressure of more than 180 mm Hg, and a diastolic
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 |
|---|---|---|
| Exercise and Lifestyle ChangePatients will undergo to weekly phone call/videoconference for 12 weeks and discuss the behaviour change. They also will undergo to home-based exercise training will be performed twice a week for 12 weeks via Zoom (up to 5 patients per session). Each session will be comprised of warm-up (10 min), the main part (15 to 20 min), and cooldown (5 to 10 min). The training aims to develop resistance, aerobic and functional capacity such as getting up, walking, pulling, pushing, throwing, transferring body weight or external loads. In addition, patients will be encouraged to increase their physical activity. Patients will be provided with a Fitbit device to monitor their step count and will be recommended to increase their previous week's average step count by 10%. | Behavioural | Exercise and Lifestyle Change, Standard Care |
Primary outcome
Feasibility of the program
Time frame: post 12 weeks
Feasibility will be determined by calculating the rate of patient screening, eligibility, recruitment, retention at 12 weeks and adherence to the intervention (number of sessions attended and completed)
Acceptability of the program
Time frame: post 12 weeks
Patient acceptability of the intervention and study experience more broadly will be determined through semi-structured qualitative 1-2-1 interviews and/or focus groups.
12 secondary outcomes
Six-minute walk test (6MWT)
Time frame: pre and post-12 weeks
Walking Impairment Questionnaire (WIQ)
Time frame: pre and post-12 weeks
Walking Estimated Limitation Calculated by History (WELCH) questionnaire
Time frame: pre and post-12 weeks
Vascular quality of life questionnaire (VascuQoL-6)
Time frame: pre and post-12 weeks
EuroQoL questionnaire (EQ-5D-5L).
Time frame: pre and post-12 weeks
Short Form Dietary Questionnaire
Time frame: pre and post-12 weeks
Physical activity levels (Fitbit Charge HR)
Time frame: pre and post-12 weeks
Sleep
Time frame: pre and post-12 weeks
Alcohol and tobacco use
Time frame: pre and post-12 weeks
Mental wellbeing
Time frame: pre and post-12 weeks
Patient activation
Time frame: pre and post-12 weeks
Resource utilisation
Time frame: pre and post-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 13 Nov 2023.
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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.
James Prentis principal investigator
Freeman Hospital - Newcastle upon Tyne 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 Exercise and Lifestyle Change in people with Peripheral Arterial Disease and Intermittent Claudication, run by Northumbria University 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 4 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: finished, as of the sponsor's last update on 13 Nov 2023. 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?
Feasibility of the program (time frame: post 12 weeks). The study lists 2 primary outcomes in all. 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 13 Nov 2023.