Community WALKing and Home-baSed circuiT tRaining in peOple liviNG With Intermittent Claudication (WALK-STRONG): a Randomised Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Intervention feasibility assessed via recruitment rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Exercise group
Home-based circuit and community walking exercise
干预措施: Exercise group (Behavioral)
Usual care
Usual activity/healthcare
结局指标
主要结局
Intervention feasibility assessed via recruitment rate
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Alex Waddell
Principle Investigator
Coventry University