A Randomized Trial of Changing Exercise and Physical Activity Behavior in Asthma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.
研究概览
简要总结
The primary objective of this randomized trial is to evaluate a novel intervention of induced positive affect and induced self-affirmation to increase physical activity in patients with asthma.
详细描述
The primary objective of this randomized trial is to evaluate a novel intervention of induced positive affect and induced self-affirmation to increase physical activity in patients with asthma. At the start of the trial all patients in conjunction with their physicians will select a program of mild to moderate physical activity or exercise to be adopted and maintained on a routine basis. All patients will record perceived exertion and pedometer measurements in a log diary. All patients will be contacted by telephone at set time intervals to encourage them to continue their selected physical activity or exercise. Patients randomized to the intervention arm will also receive induced positive affect and self-affirmation throughout the study period. Patients in the control arm will not receive the positive affect and self-affirmation components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be eligible for this study
- •if their physicians consider them medically able to participate, if they are 18 years of age or older
- •if they have a diagnosis of mild to moderate asthma based on the NHLBI Asthma Expert Panel's classification system which rates symptoms, frequency of exacerbations, nocturnal attacks, activity restriction, use of medications, and pulmonary function.
排除标准
- •Patients will be excluded from this study for the following reasons:
- •If they are unable to walk several blocks for whatever reason;
- •If they have musculoskeletal or neurological deficits that preclude increased physical activity;
- •If they have other pulmonary diseases;
- •If they have cardiac disease or other severe comorbidity;
- •If they are unable to provide informed consent because of cognitive deficits;
- •If they refuse to participate.
结局指标
主要结局
The primary outcome will be change in Paffenbarger Physical Activity and Exercise Index scores from enrollment to 12 months.
时间窗: every 2 months for 1 year
次要结局
- Pedometer readings from enrollment to 12 months.(every 2 months for 1 year)
- Change in asthma status measured by the Asthma Control Questionnaire from enrollment to 12 months.(baseline and one year after enrollment at closeout)
- Change in quality of life measured by the Asthma Quality of Life Questionnaire enrollment to 12 months.(at baseline, 4-,8-month follow-ups and one year after enrollment at closeout)
- Changes in the SF-12 from enrollment to 12 months.(baseline and one year after enrollment at closeout)
研究者
Mary E. Charlson, MD
Principal Investigator
Weill Medical College of Cornell University