Effects of a Brief Pedometer-based Behavioural Intervention for Individuals With COPD During In-patient Pulmonary Rehabilitation on 6-weeks and 6-months Objectively Measured Physical Activity - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- Changes in objectively measured physical activity
研究概览
简要总结
The STAR-study (STay Active after Rehabilitation) investigates in a randomized controlled trial (RCT) the additional effect of a pedometer-based behavior change intervention (BCI) during in-patient pulmonary rehabilitation (PR) on objectively measured physical activity (PA) 6-weeks and 6-months post PR. The BCI uses the behaviour change techniques a) instruction on how, where and when to perform the behavior, b) prompt goal setting for physical activity, c) prompt self-monitoring of behavior and d) feedback on behavior. The primary outcome of PA will be measured using an accelerometer (Actigraph wGT3X) for a time period of seven days, firstly two weeks before rehabilitation begins (T0 = study phase I) as well as six weeks and six months (T3 and T4) after PR. Additionally to predict PA progression after PR, a complex personal diagnostic, including questionnaires as well as functional assessments, is to be carried out at the start (T1 = start of study phase II) and end of PR (T2). This diagnostic is based on the main ideas of the PA-related health competence model (PARC-model) and especially incorporates physical and psychological personal determinants of PA.
详细描述
A detailed description will be available in the study protocol publication which is generated at the moment (August, 2016).
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main diagnosis for the Pulmonary Rehabilitation is an International Classification of Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) Classifications A-D and stages 1-4.
排除标准
- •Considerably reduced health status (severe concomitant disease, which will affect the results of the outcome parameters, for example, cancer or severe cardiac, neurological or orthopaedic comorbidities)
- •Considerable reduction of sight and hearing
- •Severe psychiatric condition as secondary diagnosis
- •Lack of ability to speak German
结局指标
主要结局
Changes in objectively measured physical activity
时间窗: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
On each measurement occasion physical activity is going to be measured on seven consecutive days with a 3-axis accelerometer (Actigraph wGT3X-BT)
次要结局
- Sport- and Movement-related Self-Concordance (SSK)(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2))
- Control competence for physical training, physical activity-specific mood regulation and self-control, physical activity-related self efficacy, psychological need satisfaction in exercise(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2))
- Stage of change algorithm for physical activity(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2))
- Patient Health Questionnaire (PHQ-D9)(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4))
- COPD Assessment Test (CAT)(2 weeks before pulmonary rehabilitation (T0); During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 weeks (T3) and 6 months (T4) after pulmonary rehabilitation)
- Intolerance of Uncertainty Scale (UI-18)(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4))
- 6 Minute Walking Test(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2))
- Dyspnea, cough, sputum, pain(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4))
- COPD-Anxiety Questionnaire (CAF)(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4))
- St. Georges Respiratory Questionnaire (SGRQ)(2 weeks before pulmonary rehabilitation (T0); During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 weeks (T3) and 6 months (T4) after pulmonary rehabilitation)
- Body-mass index, obstruction, dyspnea, and exercise (BODE index)(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2))
- Baseline dyspnea index (BDI) and transitional dyspnea Index (TDI)(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4))
- Single-target Implicit Association Test (ST-IAT)(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2))
- Breathlessness Catastrophizing(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4))
- Life Orientation Test-Revised (LOT-R)(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4))
- Demographic characteristics(During the first week of pulmonary rehabilitation (T1))
- Social medical characteristics(During the first week of pulmonary rehabilitation (T1))
- Fear avoidance COPD(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2); 6 months after pulmonary rehabilitation (T4))
- Sick days and use of health care services(6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4))
- Self-reported physical activity(2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4))
- Affective explicit attitudes towards performing sports activities(During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2))
- Satisfaction with the pulmonary rehabilitation(During the third and thus last week of pulmonary rehabilitation (T2))
研究者
Prof. Dr. Klaus Pfeifer
Prof. Dr.
University of Erlangen-Nürnberg