High Intensity Interval Training In pATiEnts With Intermittent Claudication (INITIATE): a Proof-of-concept Prospective Cohort Study to Assess Acceptability, Feasibility and Potential Clinical Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Tolerability Test - Related Withdrawals
研究概览
简要总结
This INITIATE study evaluates the use of high-intensity interval training as a treatment modality for patients with intermittent claudication - an ambulatory leg pain caused by narrowed arteries that supply the lower limbs.
It is an observational cohort study considering high-intensity interval training (HIIT) as a treatment for intermittent claudication, consisting of two workstreams. Workstream 1: an initial observational cohort study to consider the feasibility of the intervention and exclusion criteria. Workstream 2: a proof of concept study utilising the altered intervention and exclusion criteria following recommendations highlighted during workstream 1.
详细描述
Patients with peripheral vascular disease (PVD) may develop a reproducible pain in their legs when they walk, which usually subsides with rest. This is known as intermittent claudication (IC) and is caused by a reduced blood supply to the legs as a result of narrowed or hardened arteries that supply the lower limbs. This ambulatory pain impedes on activities of daily living, functional capacity and quality of life.
National Institute for Health and Care Excellence (NICE) clinical guidance recommends a 12-week supervised exercise programme as first-line treatment for IC, whereby patients are encouraged to walk to the point of maximal pain. Robust clinical trials have demonstrated that supervised exercise programmes are efficacious for improving both pain-free and maximal walking distances, whilst also potentially improving quality of life.
Despite this, supervised exercise programmes are vastly under-utilised and not always available to consultant vascular surgeons. This means that further programmes need to be developed in order to provide a range of options to patients to improve uptake and adherence rates. One such programme is a 6-week high-intensity interval training programme.
An initial observational cohort study of the 6 week HIIT programme will be conducted to determine to determine the feasibility of the intervention and inclusion criteria. The results from this will be used to make any necessary changes to the HIIT intervention before moving into a proof of concept study, considering the utility, safety, acceptability and potential clinical efficacy of this programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Tolerability Test - Related Withdrawals
时间窗: From the first to last exercise session, i.e. from week 0 to week 6.
Defined by examining the number of withdrawals related to the intervention or study procedures (i.e. patients unable to tolerate).
Feasibility Test
时间窗: From study opening to completion/withdrawal of the last patient
Feasibility measures included the number of patients screened vs. the number eligible, the number of patients eligible vs. the number recruited and the number recruited vs. the number completed.
Tolerability Test - Achieving the Required Intensity
时间窗: From the first to last exercise session, i.e. from week 0 to week 6.
Considers the patients ability to achieve and maintain exercise at the appropriate intensity for the duration of each session
Tolerability Test - Number of Sessions Completed
时间窗: From the first to last exercise session, i.e. from week 0 to week 6.
Considers the number of sessions completed compared to the theoretical number.
Tolerability Test - Number of HIIT Intervals Completed
时间窗: From the first to last exercise session, i.e. from week 0 to week 6.
Considers the number of HIIT intervals completed compared to the theoretical number.
次要结局
- Safety Events Recorded(From enrolment to completion of 12-week follow-up)
- Acceptability Testing(post-intervention follow-up, i.e. week 6.)
- Maximum Walking Distance(Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.)
- Peak Oxygen Uptake(Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.)
- Quality of Life Questionnaire Short-form-36 (SF-36)(4 weeks (week 10) and 12 weeks (week 18) post-intervention)
- Vascular Quality of Life Questionnaire - (VascuQol)(4 weeks (week 10) and 12 weeks (week 18) post-intervention.)
- Ankle-Brachial Pressure Index(Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.)
- Peak Power Output(Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.)
- Pain-free Walking Distance(Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.)
- Ventilatory Anaerobic Threshold (VAT)(Baseline, post-intervention (week 6), then 4 weeks (week 10) and 12 weeks (week 18) post-intervention.)