Pedometer-based Behavioural Intervention for Individuals With COPD to Stay Active After Rehabilitation

Study Overview
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Brief Summary
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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
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A detailed description will be available in the study protocol publication which is generated at the moment (August, 2016).

Official Title
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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

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Behavioral: Pedometer-based activity promotion
* Behavioral: Short patient education and exercise
* Other: Pulmonary rehabilitation (Standard care)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pedometer-based activity promotion<br>In the context of pulmonary rehabilitation (standard care), the intervention group (IG) additionally receives a pedometer-based physical activity behaviour change intervention (BCI). | Behavioral: Pedometer-based activity promotion<br>* 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.<br>Other: Pulmonary rehabilitation (Standard care)<br>* 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.<br>|
| Active Comparator: Short patient education and exercise<br>In the context of pulmonary rehabilitation (standard care), the control group (CG) additionally receives a short patient education in combination with related exercise. | Behavioral: Short patient education and exercise<br>* 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.<br>Other: Pulmonary rehabilitation (Standard care)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 | 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) | 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 | 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 | 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 | 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 | 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) | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | During the first week of pulmonary rehabilitation (T1) | 
| Social medical characteristics | Initial physical examination including diagnosis, medication, smoking status, lung function | 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 | 6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4) | 
| Fear avoidance COPD | Questionnaire: COPD disease-related fears | 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 | 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Rehabilitation, Physical Activity, Behaviour Change, Pedometer