Peripheral Artery DiseaseWALKSTRONGNCT05059899
Home-based Circuit Training for People With Intermittent Claudication
A study testing Exercise group in people with Peripheral Artery Disease and Intermittent Claudication, run by Coventry University at 1 site in United Kingdom.
Trial summary
The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Intermittent Claudication
- What is being tested?
- Exercise group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 May 2022to 26 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ankle/brachial index (ABPI) < 0.9 at rest or a drop of 20mmHg after exercise testing
- Ability to walk independently
- English speaking
- Able to follow instructions
- ≥ 18 years of age
Who cannot join
- Unable to provide informed consent
- Walking impairment for a reason that is not PAD
- Critical limb ischaemia
- Asymptomatic PAD
- Active cancer treatment
- Severe mental or physical limitations precluding participation safely in the home environment
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Coventry University
Coventry, West Midlands, CV1 2DS
About this study
Official title: Community WALKing and Home-baSed circuiT tRaining in peOple liviNG With Intermittent Claudication (WALK-STRONG): a Randomised Controlled Feasibility Trial
The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.
Read the detailed description
30 participants with PAD will be randomised to one of two groups: either exercise or usual care. The 12 week exercise intervention will consist of a home-based circuit programme, including both resistance exercises and walking. This will be combined with promoting free-living walking throughout the rest of the week. Exercise will be regulated via the use of a wearable activity monitor. Biweekly phone calls will address compliance with the intervention. The primary outcomes are feasibility and acceptability, which will be determined after 12 weeks via recruitment and attrition rates, protocol adherence and with participant interviews. Secondary outcomes include changes in pain-free and maximal walking distances with both a graded treadmill test and six-minute walk test, hand grip strength, physical activity behaviour (measured with an accelerometer), quality of life (measured with the SF-36, VascuQol and E5-5D-5L questionnaires) after 12 and 24 weeks. Investigators will also assess changes in markers of inflammation, vascular remodeling, mitochondrial biogenesis and oxidative stress at 12 and 24 weeks. Other outcomes include changes in time spent resting during a six-minute walk test and time to pain cessation following a graded treadmill test at 12 and 24 weeks.
- Being tested
- Exercise group
- Keywords
- home-based exercise, circuit training, walking
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise groupBehavioural
The exercise group will receive a 12-week home-based exercise programme, with a wearable activity watch to regulate physical activity behaviour. This group will also receive biweekly telephone calls from the investigator.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Home-based circuit and community walking exercise Receives: Behavioral: Exercise group |
| Usual care | No intervention | Usual activity/healthcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention feasibility assessed via recruitment rate
The investigators will record the number of eligible participants, as well as the number who enroll onto the study.
Measured: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
Intervention feasibility assessed via attrition rate
The investigators will record the number of protocol discontinuations and losses to follow-up.
Measured: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
Intervention feasibility assessed via protocol adherence
The investigators will examine discrepancies between intervention prescription and what is completed.
Measured: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
Intervention acceptability via participant interviews
One-to-one interviews will be held between an investigator and participant who has either completed the intervention, withdrawn or declined participation, to ask questions regarding the intervention protocol.
Measured: Will be evaluated after the intervention period (either at 12 week or 24 week follow up)
Secondary outcomes (9)
12 and 24 week change in six-minute walk distance and pain-free walk distance
Change in six-minute and pain-free walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.
Measured: Baseline to 12 weeks and 24 weeks
12 and 24 week change in pain-free and maximal treadmill walk distance
Change in pain-free and maximal treadmill walk distance after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.
Measured: Baseline to 12 weeks and 24 weeks
12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer)
Change in left and right hand grip strength after 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group.
Measured: Baseline to 12 weeks and 24 weeks
12 and 24 week change in physical activity measured by accelerometer data
Change in physical activity behaviour at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group, using accelerometer data.
Measured: Baseline to 12 weeks and 24 weeks
12 and 24 week change in SF-36 score
Change in 36 Item Short Form survey scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 0-100, with higher scores associated with a better outcome).
Measured: Baseline to 12 weeks and 24 weeks
12 and 24 week change in VascuQol questionnaire score
Change in Vascular Quality of Life questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Score ranges from 1-7, with higher scores associated with a better outcome).
Measured: Baseline to 12 weeks and 24 weeks
12 and 24 week change in EQ-5D-5L questionnaire score
Change in European Quality of Life Five Dimension questionnaire scores at 12 and 24 weeks will be compared to participants randomised to the exercise group vs the usual care group. (Scores range from 1-5, with lower scores associated with a better outcome).
Measured: Baseline to 12 weeks and 24 weeks
12 and 24 week change in circulating markers of inflammation
Investigators will compare blood sample measures of IL-6, TNF-α, CRP between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks.
Measured: Baseline to 12 weeks and 24 weeks
12 and 24 week change in circulating markers of vascular remodelling
Investigators will compare blood sample measures of VEGF between participants randomised to the exercise group vs the usual care group at 12 and 24 weeks.
Measured: Baseline to 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2021
- Study start9 May 2022
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
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 Peripheral Artery 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coventry University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- Responsible party
- Principal investigator, Alex Waddell, Coventry University
- Investigators
- Alexander Waddell, MSc, Principal investigator, Coventry University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05059899
- Sponsor's protocol ID
- P123339
- Acronym
- WALKSTRONG
- Status last verified
- Aug 2023
- First submitted
- 17 Sep 2021
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Waddell A, Denton F, Powell R, Broom DR, Birkett ST, McGregor G, Harwood AE. "It's put a routine and regimen in my life" - Participant experiences with a programme of community walking and home-based circuit training for intermittent claudication. J Vasc Nurs. 2024 Dec;42(4):276-281. doi: 10.1016/j.jvn.2024.09.003. Epub 2024 Sep 28.
PubMed 39645388
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community WALKing and Home-baSed circuiT tRaining in peOple liviNG With Intermittent Claudication (WALK-STRONG): a Randomised Controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05059899
- Acronym / sponsor ID
- WALKSTRONG / P123339
- Keywords
- home-based exercise, circuit training, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Coventry UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Coventry and Warwickshire NHS Trust
- Study start
- 9 May 2022 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 28 Sep 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.
The purpose of the study is to assess the feasibility of undertaking a randomised controlled trial investigating the effectiveness of a 12-week home-based exercise programme for people with intermittent claudication.
Detailed description
30 participants with PAD will be randomised to one of two groups: either exercise or usual care. The 12 week exercise intervention will consist of a home-based circuit programme, including both resistance exercises and walking. This will be combined with promoting free-living walking throughout the rest of the week. Exercise will be regulated via the use of a wearable activity monitor. Biweekly phone calls will address compliance with the intervention. The primary outcomes are feasibility and acceptability, which will be determined after 12 weeks via recruitment and attrition rates, protocol adherence and with participant interviews. Secondary outcomes include changes in pain-free and maximal walking distances with both a graded treadmill test and six-minute walk test, hand grip strength, physical activity behaviour (measured with an accelerometer), quality of life (measured with the SF-36, VascuQol and E5-5D-5L questionnaires) after 12 and 24 weeks. Investigators will also assess changes in markers of inflammation, vascular remodeling, mitochondrial biogenesis and oxidative stress at 12 and 24 weeks. Other outcomes include changes in time spent resting during a six-minute walk test and time to pain cessation following a graded treadmill test at 12 and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: Exercise groupHome-based circuit and community walking exercise |
| Usual care | No intervention | –Usual activity/healthcare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ankle/brachial index (ABPI) < 0.9 at rest or a drop of 20mmHg after exercise testing
- Ability to walk independently
- English speaking
- Able to follow instructions
- ≥ 18 years of age
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Walking impairment for a reason that is not PAD
- Critical limb ischaemia
- Asymptomatic PAD
- Active cancer treatment
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 groupThe exercise group will receive a 12-week home-based exercise programme, with a wearable activity watch to regulate physical activity behaviour. This group will also receive biweekly telephone calls from the investigator. | Behavioural | Exercise group |
Primary outcome
Intervention feasibility assessed via recruitment rate
Time frame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
The investigators will record the number of eligible participants, as well as the number who enroll onto the study.
Intervention feasibility assessed via attrition rate
Time frame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
The investigators will record the number of protocol discontinuations and losses to follow-up.
Intervention feasibility assessed via protocol adherence
Time frame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
The investigators will examine discrepancies between intervention prescription and what is completed.
Intervention acceptability via participant interviews
Time frame: Will be evaluated after the intervention period (either at 12 week or 24 week follow up)
One-to-one interviews will be held between an investigator and participant who has either completed the intervention, withdrawn or declined participation, to ask questions regarding the intervention protocol.
9 secondary outcomes
12 and 24 week change in six-minute walk distance and pain-free walk distance
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 week change in pain-free and maximal treadmill walk distance
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer)
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 week change in physical activity measured by accelerometer data
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 week change in SF-36 score
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 week change in VascuQol questionnaire score
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 week change in EQ-5D-5L questionnaire score
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 week change in circulating markers of inflammation
Time frame: Baseline to 12 weeks and 24 weeks
12 and 24 week change in circulating markers of vascular remodelling
Time frame: Baseline to 12 weeks and 24 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 22 Aug 2023.
- Derived from this study: PubMed 39645388Waddell A, Denton F, Powell R, Broom DR, Birkett ST, McGregor G, Harwood AE. "It's put a routine and regimen in my life" - Participant experiences with a programme of community walking and home-based circuit training for intermittent claudication. J Vasc Nurs. 2024 Dec;42(4):276-281. doi: 10.1016/j.jvn.2024.09.003. Epub 2024 Sep 28.
- 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.
Alexander Waddell, MSc principal investigator
Coventry University
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 group in people with Peripheral Artery Disease and Intermittent Claudication, run by Coventry 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 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: finished, as of the sponsor's last update on 22 Aug 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?
Intervention feasibility assessed via recruitment rate (time frame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)). The study lists 4 primary outcomes in all. 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 NCT05059899, 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 22 Aug 2023.