Investigating the Role of Skeletal Muscle Dysfunction on Dyspnea and Exercise Intolerance in Interstitial Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in standardized dyspnea score during the constant load exercise test (visit 3)
研究概览
简要总结
Dyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why. It has been suggested that muscle dysfunction may contribute to dyspnea and exercise intolerance in ILD. Our study aims to: i) examine differences in the structure and function of the leg muscles in ILD patients, ii) determine if leg muscle fatigue contributes to dyspnea and exercise limitation in patients with ILD, and iii) determine the effects of breathing extra oxygen on leg muscle fatigue, as well as ability to exercise in ILD patients.
详细描述
PURPOSE:
The primary purpose of the proposed work is to characterize skeletal muscle function in patients with interstitial lung disease (ILD), and to determine the physiological and sensory consequences of impaired skeletal muscle function in ILD during exercise.
HYPOTHESES:
The hypotheses are threefold; i) patients with ILD will have impaired skeletal muscle function when compared to healthy controls, ii) impairments in skeletal muscle function predispose ILD patients to exercise-induced quadriceps muscle fatigue, increase the perception of exertional dyspnea, as well as reduce exercise tolerance, and iii) delivery of supplemental oxygen during exercise mitigates exercise-induced quadriceps muscle fatigue, attenuates the perceived intensity of dyspnea, and improves exercise tolerance.
OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for ILD Patients:
- •Age 40-80 years (inclusive)
- •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
- •Appropriate candidate for pulmonary rehabilitation
- •6 minute walk distance 50m or more
- •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
- •Inclusion Criteria for Healthy Controls:
- •Age 40-80 (inclusive)
- •Normal pulmonary function (80-120% predicted)
- •No lung or cardiovascular disease
- •Can fluently read and write in English
排除标准
- •for the ILD patients:
- •Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
- •Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- •Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
- •Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
- •Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
- •Significant emphysema (less than 10% volume on HRCT or FEV1/FVC less than 0.70)
- •Exclusion Criteria for Healthy Controls:
- •Currently smoking or previously smoked more than 10 pack-years
- •Any medical conditions that prevents them for exercising safely
- •Cardiac pacemaker or any metal or electronic inside the body
研究组 & 干预措施
Healthy Controls
During exercise on visit 3, participants in both groups (i.e., ILD patients and controls) will breathe ambient air (i.e., 20.93% oxygen) during constant-load exercise.
干预措施: Hyperoxia (Biological)
Hyperoxia
During exercise on visit 4, participants in both groups (i.e., ILD patients and controls) will breathe supplemental oxygen (i.e., 60% oxygen) during constant-load exercise.
干预措施: Hyperoxia (Biological)
结局指标
主要结局
Change in standardized dyspnea score during the constant load exercise test (visit 3)
时间窗: Dyspnea will be measured once every minute during exercise on visit 3 (up to 7 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes)
Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 3.
Change in standardized dyspnea score during the constant load exercise test (visit 4)
时间窗: Dyspnea will be measured once every minute during exercise on visit 4 (up to 8 weeks after baseline) until participants reach volitional exhaustion (assessed for up to 30 minutes)
Dyspnea rating, measured using the Borg 0-10 category ratio scale, will be assessed every 1 minute during the constant-load exercise test on visit 4.
Change in leg muscle strength measured following the constant load exercise test (visit 3)
时间窗: Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 3 (up to 8 weeks after baseline)
Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 3 using the femoral magnetic stimulation technique.
Change in leg muscle strength measured following the constant load exercise test (visit 4)
时间窗: Leg muscle strength will be measured before and after exercise (assessed for up to 40 minutes) on visit 4 (up to 8 weeks after baseline)
Leg muscle strength will be measured before (at rest) and 3 min after the constant-load exercise test on visit 4 using the femoral magnetic stimulation technique.
次要结局
- Quadriceps muscle oxidative capacity measured using near-infrared spectroscopy(On visit 2, approximately 3 weeks post-baseline (visit 1))
- Quadriceps muscle volume measured using magnetic resonance imaging(On visit 2, approximately 3 weeks post-baseline (visit 1))
研究者
Jordan Guenette
Associate Professor
University of British Columbia