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临床试验/NCT02930421
NCT02930421已完成不适用

Clinical and Physiological Effects of Exercise Training in Symptomatic Patients With Mild COPD

Pontificia Universidad Catolica de Chile1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Change in the six minute walking distance

研究概览

简要总结

The primary aim of this clinical study is to investigate if exercise training can improve exercise capacity and quality of life in dyspneic mild chronic obstructive pulmonary disease patients.

详细描述

Peripheral muscle mass and function can be impaired in patients with mild chronic obstructive pulmonary disease (COPD). Quadriceps cross-sectional area is reduced in these patients compared to controls [1], particularly in those with dyspnea as compared to non-dyspneic counterparts and smoker controls [2]. Reduced physical activity is closely related to peripheral muscle mass in mild COPD [1], suggesting that early therapeutic interventions are needed in this group of patients. In addition, reduced quadriceps mass is strongly associated to quadriceps weakness [3,4] and a substantial proportion of patients with mild COPD (28%) had quadriceps weakness [5]. Reduced muscle mass and resultant muscle weakness contribute to limiting exercise in COPD [6-8] and to reduce physical activity, particularly in mild disease [1].

Exercise training (ET) is widely used in patients with moderate-to-very-severe COPD to improve peripheral muscle function and thus exercise capacity and quality of life [9]. Unfortunately, the effects of ET in mild COPD are currently unclear. A recent systematic review identified three low-quality studies with different designs (retrospective, one group pre-posttest, and one randomized controlled trial) [10]. The authors found significant improvements in exercise capacity (effect size 0.87-1.82) and quality of life (effect size 0.24-0.86) after comparing pretest-posttest data and ET with usual care. Although these results are inconclusive and indicate that additional and more robust studies should be conducted [10], current recommendations to initiate ET include even mild disease if dyspnea or exercise limitation are present [11]. Since peripheral muscle mass and function improve with ET [9], the investigators hypothesize that this statement is correct and consequently ET will increase exercise capacity in dyspneic patients with mild COPD in comparison to usual care.

Patients will enter an 8-week ET program of 3 days per week supervised exercise training at the Rehabilitation Physiotherapy Gymnasium. Exercise training will include high-intensity endurance training at 60-80% of baseline peak work rate and strength training of upper and lower limbs with 3 sets of 6 repetitions at 50% of one repetition maximum [12,13]. Each session will be 60 min duration, 30 min dedicated to cycle exercise. The UC group will receive usual outpatient care and follow-up.

The study will require 30 patients per arm to detect an effect size of 0.88 [10] at the 5% significance level and with 80% power, allowing a dropout rate of 30%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female subjects, aged 45-80 years
  • baseline post-bronchodilator forced expiratory volume at one second (FEV1) ≥80% of predicted normal and baseline (post-bronchodilator) FEV1/forced vital capacity (FVC) ≤70%
  • current or ex-smokers with a smoking history of at least 10 pack-years
  • dyspnea during activities of daily life, defined as modified Medical Research Council (mMRC) scale [0-4 points] ≥1 point

排除标准

  • history of asthma or other chronic lung disease (e.g.: interstitial lung disease; sarcoidosis; tuberculosis; cystic fibrosis; bronchiectasis; previous lung resection)
  • comorbidities that would prevent the patient from performing an exercise test (including psychological or cognitive disorders): chronic congestive heart failure; recent myocardial infarction [6 months or less]; cardiac arrhythmia requiring drug therapy; neuromuscular and peripheral vascular diseases
  • the presence of usual co-morbidities, such as essential hypertension, diabetes, osteoporosis, hypothyroidism, under proper medical control, and obesity, excluding extreme obesity, will not be considered an exclusion criterion.

研究组 & 干预措施

Exercise training (ET)

Experimental

Patients will enter an 8-week ET program of 3 days per week supervised exercise training at the Rehabilitation Physiotherapy Gymnasium. Exercise training will include high-intensity endurance training at 60-80% of baseline peak work rate and strength training of upper and lower limbs with 3 sets of 6 repetitions at 50% of one repetition maximum. Each session will be 60 min duration, 30 min dedicated to cycle exercise.

干预措施: Exercise training (Other)

Usual care (UC)

No Intervention

The UC group will receive usual outpatient care and follow-up.

结局指标

主要结局

Change in the six minute walking distance

时间窗: Baseline and 8 weeks

次要结局

  • Change in disease specific quality of life (SGRQ)(Baseline and 8 weeks)
  • Change in exercise time during constant-load cycle exercise(Baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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