Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
Pulmonary Rehabilitation, Physical Activity, Behaviour Change, Pedometer
Brief summary
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.
Detailed description
A detailed description will be available in the study protocol publication which is generated at the moment (August, 2016).
Interventions
BEHAVIORALPedometer-based activity promotion
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.
BEHAVIORALShort patient education and exercise
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.
OTHERPulmonary rehabilitation (Standard care)
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.
Sponsors
Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics
German Statutory Pension Insurance
University of Erlangen-Nürnberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in objectively measured physical activity | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Questionnaire: Depression |
| 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) | Questionnaire: Including body-mass index, airflow obstruction (FEV1), dyspnea (MRC-dyspnea scale) and exercise capacity (6-Min-Walk-Test) |
| 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) | Questionnaire: Baseline and transitional dyspnea |
| 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) | Questionnaire: Numeric Rating Scales (self-developed) |
| 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 | Questionnaire: Health-related quality of life |
| 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 | Questionnaire: Impact of COPD on health status |
| 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) | Questionnaire: Facets of physical activity-related health competence (PARC-Model) |
| 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) | Computer-based test: Automatic affect towards physical activity |
| 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) | Questionnaire: Adapted based on the transtheoretical model (TTM) |
| 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) | Questionnaire: Self-concordance/ quality of motivation |
| 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) | Questionnaire: COPD specific anxiety |
| 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) | Questionnaire: Breathlessness Catastrophizing Scale |
| 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) | Questionnaire: Disposition to react negative on uncertain situations |
| 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) | Questionnaire: Dispositional optimism |
| 6 Minute Walking Test | During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2) | Functional Test |
| Satisfaction with the pulmonary rehabilitation | During the third and thus last week of pulmonary rehabilitation (T2) | Questionnaire (self-developed): Satisfaction with interventional components of the pulmonary rehabilitation |
| Demographic characteristics | During the first week of pulmonary rehabilitation (T1) | Questionnaire: sex, age, height, marital status, education, weight, self-reported work status |
| Social medical characteristics | During the first week of pulmonary rehabilitation (T1) | Initial physical examination including diagnosis, medication, smoking status, lung function |
| Sick days and use of health care services | 6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4) | Questionnaire: Days of incapacity to work, days in hospital, COPD-related emergency treatment |
| 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) | Questionnaire: COPD disease-related fears |
| Self-reported physical activity | 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4) | Questionnaire: Physical Activity, Exercise, and Sport |
| 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) | Questionnaire: Explicit cognitive and affective attitudes toward sports activities |
Countries
Germany
Outcome results
None listed