Pedometer-based Behavioural Intervention for Individuals With COPD to Stay Active After Rehabilitation
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Behavioral: Pedometer-based activity promotionBehavioral: Short patient education and exerciseOther: Pulmonary rehabilitation (Standard care)
- Registration Number
- NCT02966561
- Lead Sponsor
- University of Erlangen-Nürnberg
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 418
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pedometer-based activity promotion Pulmonary rehabilitation (Standard care) In the context of pulmonary rehabilitation (standard care), the intervention group (IG) additionally receives a pedometer-based physical activity behaviour change intervention (BCI). Pedometer-based activity promotion Pedometer-based activity promotion In the context of pulmonary rehabilitation (standard care), the intervention group (IG) additionally receives a pedometer-based physical activity behaviour change intervention (BCI). Short patient education and exercise Short patient education and exercise In the context of pulmonary rehabilitation (standard care), the control group (CG) additionally receives a short patient education in combination with related exercise. Short patient education and exercise Pulmonary rehabilitation (Standard care) In the context of pulmonary rehabilitation (standard care), the control group (CG) additionally receives a short patient education in combination with related exercise.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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)
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)
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
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
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
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
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)
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
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
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
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
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
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
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
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
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
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
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
Trial Locations
- Locations (1)
Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics
🇩🇪Bad Reichenhall, Bavaria, Germany