Community WALKing and Home-baSed circuiT tRaining in peOple liviNG With Intermittent Claudication (WALK-STRONG): a Randomised Controlled Feasibility Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Peripheral Artery Disease
- Sponsor
- Coventry University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Intervention feasibility assessed via recruitment rate
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Alex Waddell
Principle Investigator
Coventry University
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 12 and 24 week change in pain-free and maximal treadmill walk distance(Baseline to 12 weeks and 24 weeks)
- 12 and 24 week change in EQ-5D-5L questionnaire score(Baseline to 12 weeks and 24 weeks)
- 12 and 24 week change in VascuQol questionnaire score(Baseline to 12 weeks and 24 weeks)
- 12 and 24 week change in circulating markers of inflammation(Baseline to 12 weeks and 24 weeks)
- 12 and 24 week change in circulating markers of vascular remodelling(Baseline to 12 weeks and 24 weeks)
- 12 and 24 week change in six-minute walk distance and pain-free walk distance(Baseline to 12 weeks and 24 weeks)
- 12 and 24 weeks change in left and right hand grip strength (via hand held dynamometer)(Baseline to 12 weeks and 24 weeks)
- 12 and 24 week change in physical activity measured by accelerometer data(Baseline to 12 weeks and 24 weeks)
- 12 and 24 week change in SF-36 score(Baseline to 12 weeks and 24 weeks)