The Effect of Physical Activity Promotion on Short and Long-term Outcomes in COPD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- 6-Minute Walk Test Distance
研究概览
简要总结
COPD currently afflicts 24 million US residents; the prevalence of COPD is high among Veterans. Persons with COPD have significant functional disability as a result of the disease. This project will determine whether a novel Internet-mediated walking program coupled with a pedometer can improve exercise capacity, improve health-related quality of life, and decrease the risk of acute exacerbations in persons with COPD. If successful, based on estimates that 33 to 64% of COPD patients are Internet users, the proposed exercise intervention could help over 8 million persons. The Veterans Health Administration (VHA) has a strong commitment to providing care to persons with COPD and supporting research directed at COPD-related disability. The 2012-2016 Strategic Plan of the VHA Office of Research and Development includes research in COPD rehabilitation. The proposed research addresses Rehabilitation R&D Service's current priority area of improving disabled Veterans' health-related quality of life by reducing disease burden and maximizing functional recovery.
详细描述
Chronic obstructive pulmonary disease (COPD) is a major cause of global morbidity and is projected to become the third leading cause of death in the world by 2020. In Veterans, the prevalence is high; in VISN1 in FY 2012, 9% of outpatient Veterans had the ICD-9 diagnosis of COPD. In COPD, shortness of breath leads to physical inactivity and significant disability. A growing body of knowledge has identified physical activity and exercise as a modifiable factor that may impact COPD-related morbidity and mortality. Epidemiological and cross-sectional studies have shown that persons with COPD who are more physically active have better functional status and are less likely to be hospitalized and to die. A higher daily step count, when directly measured, is associated with lower risk of acute exacerbations (AEs) and mortality in COPD, independent of lung function. Despite the potential benefits, there have been few interventions to increase walking in persons with COPD. Although supervised pulmonary rehabilitation programs improve exercise capacity, they are not accessible to all who could benefit from them and have low adherence rates.
Novel interventions that incorporate strategies for behavioral change and that are accessible, individualized, and sustained are needed to promote physical activity in persons limited by COPD. Funded by a RR&D CDA-2 Dr. Moy and her team have developed and piloted a novel exercise intervention that combines a website with a pedometer to promote walking in persons with COPD. The program, Every Step Counts (ESC) for Lung Health, accurately monitors walking, provides iterative feedback and individualized goal-setting, and delivers education and motivation.
This study proposes a 2-arm randomized, controlled trial to study the efficacy of ESC to improve exercise capacity in persons with COPD, compared to usual care (verbal and written instructions to exercise).
Primary Aim: Determine the efficacy of the ESC intervention to increase 6-minute walk test (6MWT) distance.
Secondary Aims: Estimate the effect of the ESC intervention on (a) health-related quality of life (HRQL), as measured by the St. George's Respiratory Questionnaire (SGRQ), (b) dyspnea, (c) inflammatory biomarkers C-reactive protein (CRP) and interleukin-6 (IL-6), (d) risk for AEs and COPD-related hospitalizations, and (e) engagement in physical activity as measured by daily step count.
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)
盲法说明
Research assistant who assesses outcomes is blinded to randomization group.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, greater than or equal to 40 years of age
- •Clinical diagnosis of COPD defined as either a ratio of FEV1 to forced vital capacity < 0.70 or chest CT evidence of emphysema. CT obtained as part of routine clinical care, independent of research study.
- •Medical clearance from healthcare provider to participate in an exercise program
- •Have an active email account and can check email at least weekly
- •Have access to a computer with Internet connection or willing to come to VABoston or Birmingham VA Medical Center to use study computers
- •Pedometer with >90% accuracy compared to manual counts on short clinic walk
- •Competent to provide informed consent
- •Willingness to make return visits and be available by telephone for duration of study
排除标准
- •COPD exacerbation in the previous 1 month
- •Unable to ambulate with or without assistance
- •Clinical signs of unstable cardiovascular disease or congestive heart failure
- •Hypoxemia during 6MWT, i.e. oxygen saturation <85% using supplemental oxygen
- •Unable to complete questionnaires
- •Unable to collect at least 5 of 7 days of baseline step counts
- •Participation in a pulmonary rehabilitation program at time of screening or within the previous 3 months
- •Participation in another exercise-related research study at time of screening
- •Plans to participate in an exercise-related research study in the next 6 months
- •Plans to enroll in a supervised exercise program, such as pulmonary rehabilitation, in the next 6 months
研究组 & 干预措施
Pedometer and Internet Website
Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
干预措施: Pedometer and Website (Behavioral)
Usual Care
Verbal instructions and written materials about exercise.
结局指标
主要结局
6-Minute Walk Test Distance
时间窗: 6 months
In-clinic test that measures exercise capacity. Change in 6MWT distance at 6 months compared to baseline.
次要结局
- Health-related Quality of Life(6 months)
- Dyspnea(6 months)
- Engagement in Physical Activity(6 months)
- Inflammatory Biomarker Number 1(6 months)