跳至主要内容
临床试验/NCT05343949
NCT05343949
终止
不适用

Promoting Activity in Chronic Obstructive Pulmonary Disease (COPD): Optimising High Intensity Interval Training and Technologies, a Pilot Study

Hull University Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 18 人2019年5月8日
适应症COPD

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
COPD
发起方
Hull University Teaching Hospitals NHS Trust
入组人数
18
试验地点
1
主要终点
Comparison of the Change from baseline in mean Borg Dyspnoea scale (the higher the score the worst the breathlessness) following HIIT protocols
状态
终止
最后更新
2年前

概览

简要总结

Trials in COPD have shown that HIIT leads to the same positive outcomes as constant load training but causes less breathlessness and leg discomfort during training. However, HIIT protocols in existing trials have all been different and use relatively long interval durations (30 s) and short rests. This is sub-optimal because long interval durations lead to greater breathlessness and patients may fear that they will not fully recover during short rests, potentially decreasing adherence. A novel HIIT protocol involving very brief intervals (e.g. 10 s) with longer rests may provide the same benefits with less distress due to breathlessness.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) is a common and disabling smoking-related lung disease that is predicted to become the 3rd leading cause of death world-wide by 2030 (WHO, 2017). The economic burden of COPD in the United Kingdom is estimated by the British Lung Foundation (BLF) to be around £48.5 billion per year - higher than all other respiratory diseases, including lung cancer. Although widespread, Hull is a COPD 'hot spot' (BLF), with prevalence and mortality rates 36% and 75% higher than the national average, respectively. COPD is characterised by symptoms of breathlessness and cough that typically progress over time. As a consequence of these symptoms, physical activity (PA) is reduced in COPD patients, with lower levels associated with higher symptom burden, hospital admissions and mortality. Breathlessness is the most commonly reported barrier to PA in COPD, resulting in a cycle of deconditioning that ultimately leads to greater breathlessness and disability. Pulmonary rehabilitation (PR) improves symptoms and increases exercise capacity in COPD but uptake and adherence are poor. Patients with greater breathlessness are less likely to complete PR programmes which is unsurprising given that exercise-induced breathlessness can be distressing in COPD. One potential solution is high-intensity interval training (HIIT). HIIT involves short bursts of high-intensity exercise interspersed with periods of rest. The short duration of high-intensity exercise can reduce distressing breathlessness during exercise in COPD, mitigating the most common barrier to exercise. As mentioned above, PR participants benefit from increased exercise capacity. However, what patients can do (exercise capacity) does not always translate into what patients do (PA) and the effect of PR on PA has been disappointing. Interventions that aim to improve PA in COPD patients have been trialed, but the quality of evidence is low and results inconsistent. Physical inactivity is the strongest predictor of mortality in COPD patients and therefore, effective interventions that increase PA are desperately needed.

注册库
clinicaltrials.gov
开始日期
2019年5月8日
结束日期
2022年11月25日
最后更新
2年前
研究类型
Interventional
研究设计
Crossover
性别
All

研究者

入排标准

入选标准

  • Mild, Moderate and severe\* COPD forced expired volume (FEV-1) ≥30 with an FEV-1/ forced vital capacity (FVC) ratio \<70%) confirmed on spirometry within 6 months of recruitment.
  • Chronic breathlessness that limits exercise capacity (mMRC ≥2).
  • Using inhaled therapy for COPD including a long-acting bronchodilator agonist (LABA and/or long acting muscarinic agonist (LAMA) with or without inhaled corticosteroids (ICS).
  • Oxygen saturations ≥90% breathing room air.
  • Willing and able to undertake study procedures.
  • Has provided informed consent. \* Mild and Moderate COPD patients will be recruited from the start of the study. A review of exercise session completion rates and adverse events will be performed after 10 patients have been recruited to assess the tolerability and acceptability of the different HIIT protocols prior to beginning recruitment of people with severe COPD

排除标准

  • Significant physical or psychological comorbidity considered by the investigator likely to affect study outcomes.
  • Active cardiovascular disease or recent significant cardiovascular event (myocardial infarction within 6 months, cardiac arrhythmias including atrial fibrillation/flutter within 6 months, unstable angina within 6 months, stable angina with current symptoms).
  • Moderate or severe COPD exacerbation within 4 weeks of screening (an exacerbation requiring treatment with steroids and/or antibiotics or leading to hospitalisation).
  • Unable or unwilling to undertake exercise as set out in the study protocol

结局指标

主要结局

Comparison of the Change from baseline in mean Borg Dyspnoea scale (the higher the score the worst the breathlessness) following HIIT protocols

时间窗: Through study completion, on average 2 wks

The Dyspnoea Borg scale was assessed at rest and then at the beginning and end of each high intensity interval. during and following each of the HIIT protocols lasting 40 min. the scale ranges from 0-10 with 0 being no breathlessness and 10 being maximum breathlesness

次要结局

  • Comparison of maximum Dyspnoea Borg score for each HIIT protocol (the higher the score the worse the breathlessness(through study completion, on average 2 wks)

研究点 (1)

Loading locations...

相似试验