Clinical trial NCT05059899: Home-based Circuit Training for People With Intermittent Claudication
Official title: Community WALKing and Home-baSed circuiT tRaining in peOple liviNG With Intermittent Claudication (WALK-STRONG): a Randomised Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Intermittent Claudication
Keywords: home-based exercise
circuit training
walking
Lead sponsor: Coventry University
Sponsor class: OTHER
Collaborators: name: University Hospitals Coventry and Warwickshire NHS Trust
First posted: 2021-09-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Intervention feasibility assessed via recruitment rate
timeFrame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
measure: Intervention feasibility assessed via attrition rate
timeFrame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
measure: Intervention feasibility assessed via protocol adherence
timeFrame: Will be evaluated after the intervention period (i.e.. 24 weeks after inclusion)
measure: Intervention acceptability via participant interviews
timeFrame: Will be evaluated after the intervention period (either at 12 week or 24 week follow up)
Secondary outcomes:
measure: 12 and 24 week change in six-minute walk distance and pain-free walk distance
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week change in pain-free and maximal treadmill walk distance
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer)
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week change in physical activity measured by accelerometer data
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week change in SF-36 score
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week change in VascuQol questionnaire score
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week change in EQ-5D-5L questionnaire score
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week change in circulating markers of inflammation
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week change in circulating markers of vascular remodelling
timeFrame: Baseline to 12 weeks and 24 weeks
Other outcomes:
measure: 12 and 24 week change in rest times during a six-minute walk test
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week change in pain cessation following a treadmill test
timeFrame: Baseline to 12 weeks and 24 weeks
measure: 12 and 24 week changes in walking speed during a six-minute walk test
timeFrame: Baseline to 12 weeks and 24 weeks
Locations:
city: Coventry
country: United Kingdom
facility: Coventry University
state: West Midlands
Study officials:
affiliation: Coventry University
name: Alexander Waddell, MSc
role: PRINCIPAL_INVESTIGATOR
References: