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.
A detailed description will be available in the study protocol publication which is generated at the moment (August, 2016).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
418
The central components of the 2 x 45 minutes lasting pedometer-based physical activity behaviour change intervention BCI are the following behaviour change techniques (BCTs): * Instruction on how, where and when to perform the behaviour * Prompt goal setting for physical activity * Prompt self-monitoring of behaviour * Feedback on behaviour. Participants receive a pedometer and a booklet with a physical activity diary and associated information on the importance of goal setting and keeping a physical activity diary, exercise recommendations, possibilities to stay active after rehabilitation and appropriate physical activities.
The central components of the 2 x 45 minutes lasting intervention are revisions of knowledge of the pulmonary rehabilitation (standard care) in combination with related exercises: * Revision of knowledge on exercise recommendations * Revision of knowledge on possibilities of self-regulation of endurance training exercise intensity with the rate of perceived exertion (BORG-Scale) * Revision of self-regulation of endurance exercise intensity * Revision of strengthening activities consistent with the exercise recommendations. Participants receive a booklet with information on the rate of perceived exertion, exercise recommendations, possibilities to stay active after rehabilitation and appropriate physical activities.
Standard care is an in-patient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention based on a patient assessment followed by a combination of patient-tailored therapies. PR lasts on average 25 days. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current COPD-guidelines; physical training (4-5 units/week endurance training \[45 min\] and 3 units/week of strength training \[45 min\] per week, 7 units/week whole body vibration muscle training/week); structured COPD-patient education (6 hours patient education COPD + 1 hour device training); respiratory physiotherapy in groups \[2-4 units/week with 45 min\]. PR is implemented by an interdisciplinary rehabilitation team.
Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics
Bad Reichenhall, Bavaria, Germany
Changes in objectively measured physical activity
On each measurement occasion physical activity is going to be measured on seven consecutive days with a 3-axis accelerometer (Actigraph wGT3X-BT)
Time frame: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
Body-mass index, obstruction, dyspnea, and exercise (BODE index)
Questionnaire: Including body-mass index, airflow obstruction (FEV1), dyspnea (MRC-dyspnea scale) and exercise capacity (6-Min-Walk-Test)
Time frame: 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)
Questionnaire: Baseline and transitional dyspnea
Time frame: 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)
Dyspnea, cough, sputum, pain
Questionnaire: Numeric Rating Scales (self-developed)
Time frame: 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)
Questionnaire: COPD specific anxiety
Time frame: 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)
Patient Health Questionnaire (PHQ-D9)
Questionnaire: Depression
Time frame: 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)
Questionnaire: Health-related quality of life
Time frame: 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
COPD Assessment Test (CAT)
Questionnaire: Impact of COPD on health status
Time frame: 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
Control competence for physical training, physical activity-specific mood regulation and self-control, physical activity-related self efficacy, psychological need satisfaction in exercise
Questionnaire: Facets of physical activity-related health competence (PARC-Model)
Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
Single-target Implicit Association Test (ST-IAT)
Computer-based test: Automatic affect towards physical activity
Time frame: 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
Questionnaire: Adapted based on the transtheoretical model (TTM)
Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
Sport- and Movement-related Self-Concordance (SSK)
Questionnaire: Self-concordance/ quality of motivation
Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
Affective explicit attitudes towards performing sports activities
Questionnaire: Explicit cognitive and affective attitudes toward sports activities
Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
Breathlessness Catastrophizing
Questionnaire: Breathlessness Catastrophizing Scale
Time frame: 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)
Intolerance of Uncertainty Scale (UI-18)
Questionnaire: Disposition to react negative on uncertain situations
Time frame: 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)
Questionnaire: Dispositional optimism
Time frame: 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
Functional Test
Time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
Satisfaction with the pulmonary rehabilitation
Questionnaire (self-developed): Satisfaction with interventional components of the pulmonary rehabilitation
Time frame: During the third and thus last week of pulmonary rehabilitation (T2)
Demographic characteristics
Questionnaire: sex, age, height, marital status, education, weight, self-reported work status
Time frame: During the first week of pulmonary rehabilitation (T1)
Social medical characteristics
Initial physical examination including diagnosis, medication, smoking status, lung function
Time frame: During the first week of pulmonary rehabilitation (T1)
Sick days and use of health care services
Questionnaire: Days of incapacity to work, days in hospital, COPD-related emergency treatment
Time frame: 6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4)
Fear avoidance COPD
Questionnaire: COPD disease-related fears
Time frame: 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)
Self-reported physical activity
Questionnaire: Physical Activity, Exercise, and Sport
Time frame: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
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