跳至主要内容
临床试验/NCT04326855
NCT04326855Unknown不适用

Methodological Validation of an Intermittent Shuttle Walking Protocol in the Context of Pulmonary Rehabilitation in Patients With Advanced COPD

Northumbria University0 个研究点目标入组 20 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
主要终点
Change in Walking distance

研究概览

简要总结

In the UK, field-based walking is prescribed in the pulmonary rehabilitation (PR) setting as a convenient, less resource-intensive, and highly responsive exercise modality in COPD patients. However, endurance time during the implementation of field-based walking protocols, such as the endurance shuttle walking (ESW) protocol, is limited to only a few minutes secondary to intense exertional symptoms. It therefore seems sensible to develop an intermittent field-based walking protocol that would prolong endurance time and walking distance compared to the commonly implemented in the PR setting continuous ESW protocol. The aim of this study is three-fold: 1) to identify whether an intermittent shuttle walking protocol significantly prolongs walking distance compared to the widely implemented continuous ESW protocol in the PR setting in patients with advanced COPD; 2) to investigate the test re-test reliability of the distance walked during the intermittent shuttle walking protocol; and 3) to explore patients' and health care professionals' experiences of implementing the intermittent walking protocol and the perceived factors affecting the implementation of these protocols in the PR setting.

The study hypothesis is that the intermittent shuttle walking protocol would be associated with lower dynamic hyperinflation and breathlessness, thereby facilitating an increase in walking distance compared to the continuous ESW protocol.

The same group of patients with advanced COPD will initially perform an incremental shuttle walk test (ISWT) (visit 1) to establish peak walking speed and subsequently patients will perform the continuous ESW protocol (visit 2) at a walking speed corresponding to 85% of peak walking speed to the limit of tolerance. On two additional visits (visits 3 and 4) patients will perform two intermittent shuttle walking protocols to the limit of tolerance by alternating 1-min walking bouts at a walking speed corresponding to 85% peak walking speed (equivalent to the ESW protocol) with 1-min rest periods in between walking bouts to establish the reproducibility of this protocol. Focus group interviews with patients and healthcare professionals will be conducted to explore perceptions of undertaking and implementing, respectively the intermittent walking protocol.

详细描述

Although previous research in the area of pulmonary rehabilitation in COPD has documented that high intensity exercise induces greater benefits than moderate intensity exercise, patients with advanced COPD patients cannot sustain sufficiently high intensities for long periods of time due to exertional breathlessness. While patients are limited by breathlessness during continuous modes of exercise, intermittent exercise is considered to be a good alternative strategy for patients with advanced COPD as it is associated with reduced exertional symptoms. Intermittent exercise consists of repeated brief bouts of physical activity at a high intensity alternated with short periods of recovery. The rationale for the implementation of intermittent exercise in healthy people and athletes has been the capacity to impose high loads to peripheral muscles without overloading the cardiorespiratory system. Working at high intensities with limited exertional symptoms enables severe COPD patients to achieve greater exercise volumes and in extend greater peripheral muscle adaptations, thereby improving exercise tolerance. International (ATS/ERS) and national (BTS) position statements for pulmonary rehabilitation recommend intermittent exercise for patients with advanced COPD. Despite the well-documented benefits of intermittent exercise, very few pulmonary rehabilitation centres in the UK employ this modality. The reason is that most of the community-based pulmonary rehabilitation programmes lack of infrastructure (stationary cycle ergometers, treadmills, rowing machines, etc.) and healthcare professionals to implement interval exercise. Hence, it is necessary to develop alternative, easily implemented and affordable, in terms of symptoms, exercise particularly for patients with advanced COPD across the community- and hospital- based pulmonary rehabilitation setting in the UK.

In the UK, field-based walking training is prescribed in the PR setting as a convenient, less resource-intensive, and highly responsive exercise modality in patients with COPD. However, in 2018, the National COPD Audit Report, reported that only 62% of enrolled patients completed a PR programme, highlighting significant drop-out rates (38%) between initial assessment and programme completion. Intense exertional symptoms during the prescribed exercise regimes was the main identified factor responsible for non-completion rates. In 1999, Revill et al, introduced a standardized, externally-paced (continuous) endurance shuttle walk (ESW) protocol as a highly responsive and repeatable assessment tool to measure endurance capacity. The ESW protocol sustained at a relatively high intensity (85% peak walking speed derived by the Incremental Shuttle Walk Test - ISWT) is commonly employed today as a walking training modality in the PR setting across the UK. However, endurance time during implementation of ESW protocol is limited to only a few minutes (5-8 minutes) secondary to intense exertional symptoms. In particular, both breathlessness and leg discomfort are considered to limit endurance time during the ESW protocol, thus suggesting that it is a highly physically demanding task for advanced COPD patients.

It therefore seems sensible to develop an intermittent shuttle walking protocol imposing sufficiently intense loads to the cardiorespiratory system and the locomotor muscles without inducing intense exertional symptoms. In turn, this would prolong endurance time and walking distance compared to the commonly implemented continuous ESW protocol. It is envisaged that an intermittent walking protocol for patients with advanced COPD will facilitate participation and successful completion of a PR programme.

Research Aims

  1. To identify whether an intermittent shuttle walking protocol is associated with tolerable exertional symptoms, thereby prolonging walking distance compared to the widely implemented continuous ESW protocol in the PR settings for patients with advanced COPD.
  2. To investigate the reproducibility of the distance walked during the intermittent shuttle walking protocol.
  3. To explore both patients' and health care professionals' experiences of undertaking and implementing, respectively the intermittent shuttle walking and the perceived factors affecting the implementation of this protocol in the PR setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged 40 years or older.
  • Current or previous smoking history: 10 or more pack years.

排除标准

  • Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
  • Moderate or severe COPD exacerbation within 6 weeks.
  • Unstable cardiac arrhythmia.
  • Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
  • Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.

结局指标

主要结局

Change in Walking distance

时间窗: The intervention will be performed within 30 days from the date of patient recruitment. Outcome 1 will be assessed at the 20th minute for the intermittent walking protocol.

Distance walked during the intermittent shuttle walking protocol compared to the distance walked during the continuous endurance shuttle walking protocol assessed in meters. Change in walking distance covered during the intermittent walking protocol.

次要结局

  • Change in Inspiratory Capacity(The intervention will be performed within 30 days from the date of patient recruitment. Outcome 6 will be assessed at the 20th minute for the intermittent walking protocol.)
  • Change in Minute Ventilation(The intervention will be performed within 30 days from the date of patient recruitment.Outcome 5 will be assessed at the 20th minute for the intermittent walking protocol.)
  • Change in Exertional Symptoms (breathlessness and leg discomfort)(The intervention will be performed within 30 days from the date of patient recruitment.Outcome 4 will be assessed at the 20th minute for the intermittent walking protocol.)
  • Change in Peak oxygen consumption (VO2 peak)(The intervention will be performed within 30 days from the date of patient recruitment.Outcome 2 will be assessed at the 20th minute for the intermittent walking protocol.)
  • Change in Cardiac output(The intervention will be performed within 30 days from the date of patient recruitment.Outcome 3 will be assessed at the 20th minute for the intermittent walking protocol.)

研究者

申办方类型
Other
责任方
Sponsor

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