The Effects of Dietary Nitrate Supplementation on Exercise Tolerance in Patients With Fibrotic Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Difference in submaximal cycle exercise endurance time following dietary nitrate supplementation compared to placebo supplementation.
研究概览
简要总结
Exercise training as part of a structured pulmonary rehabilitation program is a key factor in improving quality of life and symptoms in people with interstitial lung disease (ILD). Optimal methods of exercise training are yet to be explored in ILD. Drinking beetroot juice, which is rich in nitrate, has been shown to improve exercise performance in a variety of groups, but its effects in ILD have not been tested. The purpose of this study is to determine if drinking nitrate-rich beetroot juice can improve exercise performance compared to drinking nitrate-free beetroot juice in people with ILD.
详细描述
PURPOSE:
The primary purpose of this study is to determine the effects of dietary nitrate supplementation on submaximal cycle exercise performance in patients with fibrotic ILD.
HYPOTHESIS:
Our primary hypothesis is that dietary nitrate supplementation will result in greater improvement in submaximal cycle exercise endurance time compared with placebo.
JUSTIFICATION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Eligible participants will be randomly assigned using a computer-generated algorithm in a 1:1 ratio to dietary nitrate supplementation (concentrated beetroot juice) or placebo (the same amount of beetroot juice but with naturally occurring nitrate removed).
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential diagnosis that consists of the above diagnoses
- •Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
- •Oxygen saturation ≥92% by pulse oximetry at rest while breathing room air
- •Clinically stable for the preceding 6 weeks
- •Can fluently read and write in English
排除标准
- •Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease) (see Table 4 from ERS/ATS consensus statement)
- •Other significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- •FVC <50% or DLCO <25%
- •Use of prednisone >10 mg/day for >2 weeks within 3 months of the first study visit
- •Cardiac pacemaker or any metal or electronics inside of the body
研究组 & 干预措施
Dietary nitrate supplementation
The dietary nitrate supplement will be a concentrated, nitrate-rich beetroot juice (70 ml providing ∼400mg nitrate per serving)
干预措施: concentrated beetroot juice (400mg of nitrate per serving) (Dietary Supplement)
Placebo
The placebo will be a concentrated, nitrate-depleted beetroot juice (70 ml with trace amounts of nitrate)
干预措施: concentrated beetroot juice (trace amounts of nitrate per serving) (Dietary Supplement)
结局指标
主要结局
Difference in submaximal cycle exercise endurance time following dietary nitrate supplementation compared to placebo supplementation.
时间窗: 1 Week
Exercise endurance time will be measured during submaximal constant load cycle exercise testing.
次要结局
- Difference in concentration of plasma nitrate ([NO3-]) and nitrite ([NO2-]) following dietary nitrate supplementation compared to placebo supplementation.(1 Week)
- Difference in resting, exercise, and post-exercise blood pressure following dietary nitrate supplementation compared to placebo supplementation.(1 Week)
- Difference in exertional dyspnoea during submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.(1 Week)
- Difference in exertional dyspnoea during activities of daily living following dietary nitrate supplementation compared to placebo supplementation.(1 Week)
- Difference in oxygen cost of submaximal cycle exercise following dietary nitrate supplementation compared to placebo supplementation.(1 Week)
- Difference in peripheral locomotor muscle oxygenation following dietary nitrate supplementation compared to placebo supplementation.(1 Week)
- Difference in post-exercise quadriceps fatigue following dietary nitrate supplementation compared to placebo supplementation.(1 Week)
研究者
Jordan Guenette
Director of Cardiopulmonary Exercise Physiology Laboratory
University of British Columbia