<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02966561</url>
  </required_header>
  <id_info>
    <org_study_id>5.011-6.031.115</org_study_id>
    <nct_id>NCT02966561</nct_id>
  </id_info>
  <brief_title>Pedometer-based Behavioural Intervention for Individuals With COPD to Stay Active After Rehabilitation</brief_title>
  <acronym>STAR</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>German Statutory Pension Insurance</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Erlangen-Nürnberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The STAR-study (STay Active after Rehabilitation) investigates in a randomized controlled&#xD;
      trial (RCT) the additional effect of a pedometer-based behavior change intervention (BCI)&#xD;
      during in-patient pulmonary rehabilitation (PR) on objectively measured physical activity&#xD;
      (PA) 6-weeks and 6-months post PR. The BCI uses the behaviour change techniques a)&#xD;
      instruction on how, where and when to perform the behavior, b) prompt goal setting for&#xD;
      physical activity, c) prompt self-monitoring of behavior and d) feedback on behavior. The&#xD;
      primary outcome of PA will be measured using an accelerometer (Actigraph wGT3X) for a time&#xD;
      period of seven days, firstly two weeks before rehabilitation begins (T0 = study phase I) as&#xD;
      well as six weeks and six months (T3 and T4) after PR. Additionally to predict PA progression&#xD;
      after PR, a complex personal diagnostic, including questionnaires as well as functional&#xD;
      assessments, is to be carried out at the start (T1 = start of study phase II) and end of PR&#xD;
      (T2). This diagnostic is based on the main ideas of the PA-related health competence model&#xD;
      (PARC-model) and especially incorporates physical and psychological personal determinants of&#xD;
      PA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A detailed description will be available in the study protocol publication which is generated&#xD;
      at the moment (August, 2016).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2016</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in objectively measured physical activity</measure>
    <time_frame>2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)</time_frame>
    <description>On each measurement occasion physical activity is going to be measured on seven consecutive days with a 3-axis accelerometer (Actigraph wGT3X-BT)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body-mass index, obstruction, dyspnea, and exercise (BODE index)</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)</time_frame>
    <description>Questionnaire: Including body-mass index, airflow obstruction (FEV1), dyspnea (MRC-dyspnea scale) and exercise capacity (6-Min-Walk-Test)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline dyspnea index (BDI) and transitional dyspnea Index (TDI)</measure>
    <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)</time_frame>
    <description>Questionnaire: Baseline and transitional dyspnea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea, cough, sputum, pain</measure>
    <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)</time_frame>
    <description>Questionnaire: Numeric Rating Scales (self-developed)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COPD-Anxiety Questionnaire (CAF)</measure>
    <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)</time_frame>
    <description>Questionnaire: COPD specific anxiety</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire (PHQ-D9)</measure>
    <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)</time_frame>
    <description>Questionnaire: Depression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St. Georges Respiratory Questionnaire (SGRQ)</measure>
    <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</time_frame>
    <description>Questionnaire: Health-related quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COPD Assessment Test (CAT)</measure>
    <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</time_frame>
    <description>Questionnaire: Impact of COPD on health status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Control competence for physical training, physical activity-specific mood regulation and self-control, physical activity-related self efficacy, psychological need satisfaction in exercise</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)</time_frame>
    <description>Questionnaire: Facets of physical activity-related health competence (PARC-Model)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single-target Implicit Association Test (ST-IAT)</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)</time_frame>
    <description>Computer-based test: Automatic affect towards physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage of change algorithm for physical activity</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)</time_frame>
    <description>Questionnaire: Adapted based on the transtheoretical model (TTM)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sport- and Movement-related Self-Concordance (SSK)</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)</time_frame>
    <description>Questionnaire: Self-concordance/ quality of motivation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Affective explicit attitudes towards performing sports activities</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)</time_frame>
    <description>Questionnaire: Explicit cognitive and affective attitudes toward sports activities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Breathlessness Catastrophizing</measure>
    <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)</time_frame>
    <description>Questionnaire: Breathlessness Catastrophizing Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intolerance of Uncertainty Scale (UI-18)</measure>
    <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)</time_frame>
    <description>Questionnaire: Disposition to react negative on uncertain situations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Orientation Test-Revised (LOT-R)</measure>
    <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)</time_frame>
    <description>Questionnaire: Dispositional optimism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minute Walking Test</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)</time_frame>
    <description>Functional Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the pulmonary rehabilitation</measure>
    <time_frame>During the third and thus last week of pulmonary rehabilitation (T2)</time_frame>
    <description>Questionnaire (self-developed): Satisfaction with interventional components of the pulmonary rehabilitation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic characteristics</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1)</time_frame>
    <description>Questionnaire: sex, age, height, marital status, education, weight, self-reported work status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social medical characteristics</measure>
    <time_frame>During the first week of pulmonary rehabilitation (T1)</time_frame>
    <description>Initial physical examination including diagnosis, medication, smoking status, lung function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sick days and use of health care services</measure>
    <time_frame>6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4)</time_frame>
    <description>Questionnaire: Days of incapacity to work, days in hospital, COPD-related emergency treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear avoidance COPD</measure>
    <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)</time_frame>
    <description>Questionnaire: COPD disease-related fears</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported physical activity</measure>
    <time_frame>2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)</time_frame>
    <description>Questionnaire: Physical Activity, Exercise, and Sport</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">418</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease (COPD)</condition>
  <arm_group>
    <arm_group_label>Pedometer-based activity promotion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the context of pulmonary rehabilitation (standard care), the intervention group (IG) additionally receives a pedometer-based physical activity behaviour change intervention (BCI).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Short patient education and exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the context of pulmonary rehabilitation (standard care), the control group (CG) additionally receives a short patient education in combination with related exercise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Pedometer-based activity promotion</intervention_name>
    <description>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):&#xD;
Instruction on how, where and when to perform the behaviour&#xD;
Prompt goal setting for physical activity&#xD;
Prompt self-monitoring of behaviour&#xD;
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.</description>
    <arm_group_label>Pedometer-based activity promotion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Short patient education and exercise</intervention_name>
    <description>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:&#xD;
Revision of knowledge on exercise recommendations&#xD;
Revision of knowledge on possibilities of self-regulation of endurance training exercise intensity with the rate of perceived exertion (BORG-Scale)&#xD;
Revision of self-regulation of endurance exercise intensity&#xD;
Revision of strengthening activities consistent with the exercise recommendations.&#xD;
Participants receive a booklet with information on the rate of perceived exertion, exercise recommendations, possibilities to stay active after rehabilitation and appropriate physical activities.</description>
    <arm_group_label>Short patient education and exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pulmonary rehabilitation (Standard care)</intervention_name>
    <description>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.</description>
    <arm_group_label>Pedometer-based activity promotion</arm_group_label>
    <arm_group_label>Short patient education and exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Main diagnosis for the Pulmonary Rehabilitation is an International Classification of&#xD;
             Diseases-Code J44.- (Other chronic obstructive pulmonary disease) at all 2011 Global&#xD;
             Initiative for Chronic Obstructive Lung Disease (GOLD) Classifications A-D and stages&#xD;
             1-4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Considerably reduced health status (severe concomitant disease, which will affect the&#xD;
             results of the outcome parameters, for example, cancer or severe cardiac, neurological&#xD;
             or orthopaedic comorbidities)&#xD;
&#xD;
          -  Considerable reduction of sight and hearing&#xD;
&#xD;
          -  Severe psychiatric condition as secondary diagnosis&#xD;
&#xD;
          -  Lack of ability to speak German&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Pfeifer, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wolfgang Geidl, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Konrad Schultz, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, Bad Reichenhall, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics</name>
      <address>
        <city>Bad Reichenhall</city>
        <state>Bavaria</state>
        <zip>83435</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Geidl W, Semrau J, Streber R, Lehbert N, Wingart S, Tallner A, Wittmann M, Wagner R, Schultz K, Pfeifer K. Effects of a brief, pedometer-based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6-week and 6-month objectively measured physical activity: study protocol for a randomized controlled trial. Trials. 2017 Aug 29;18(1):396. doi: 10.1186/s13063-017-2124-z.</citation>
    <PMID>28851462</PMID>
  </reference>
  <results_reference>
    <citation>Geidl W, Carl J, Cassar S, Lehbert N, Mino E, Wittmann M, Wagner R, Schultz K, Pfeifer K. Physical Activity and Sedentary Behaviour Patterns in 326 Persons with COPD before Starting a Pulmonary Rehabilitation: A Cluster Analysis. J Clin Med. 2019 Aug 29;8(9):1346. doi: 10.3390/jcm8091346.</citation>
    <PMID>31470678</PMID>
  </results_reference>
  <results_reference>
    <citation>Janssens T, Van de Moortel Z, Geidl W, Carl J, Pfeifer K, Lehbert N, Wittmann M, Schultz K, von Leupoldt A. Impact of Disease-Specific Fears on Pulmonary Rehabilitation Trajectories in Patients with COPD. J Clin Med. 2019 Sep 13;8(9):1460. doi: 10.3390/jcm8091460.</citation>
    <PMID>31540306</PMID>
  </results_reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>October 7, 2016</study_first_submitted>
  <study_first_submitted_qc>November 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 17, 2016</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Klaus Pfeifer</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>Pulmonary Rehabilitation</keyword>
  <keyword>Physical Activity</keyword>
  <keyword>Behaviour Change</keyword>
  <keyword>Pedometer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02966561
org study id: 5.011-6.031.115
nct id: NCT02966561
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in objectively measured physical activity
time frame: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
description: On each measurement occasion physical activity is going to be measured on seven consecutive days with a 3-axis accelerometer (Actigraph wGT3X-BT)
measure: Body-mass index, obstruction, dyspnea, and exercise (BODE index)
time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
description: Questionnaire: Including body-mass index, airflow obstruction (FEV1), dyspnea (MRC-dyspnea scale) and exercise capacity (6-Min-Walk-Test)
measure: Baseline dyspnea index (BDI) and transitional dyspnea Index (TDI)
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)
description: Questionnaire: Baseline and transitional dyspnea
measure: Dyspnea, cough, sputum, pain
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)
description: Questionnaire: Numeric Rating Scales (self-developed)
measure: COPD-Anxiety Questionnaire (CAF)
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)
description: Questionnaire: COPD specific anxiety
measure: Patient Health Questionnaire (PHQ-D9)
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)
description: Questionnaire: Depression
measure: St. Georges Respiratory Questionnaire (SGRQ)
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
description: Questionnaire: Health-related quality of life
measure: COPD Assessment Test (CAT)
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
description: Questionnaire: Impact of COPD on health status
measure: Control competence for physical training, physical activity-specific mood regulation and self-control, physical activity-related self efficacy, psychological need satisfaction in exercise
time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
description: Questionnaire: Facets of physical activity-related health competence (PARC-Model)
measure: Single-target Implicit Association Test (ST-IAT)
time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
description: Computer-based test: Automatic affect towards physical activity
measure: Stage of change algorithm for physical activity
time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
description: Questionnaire: Adapted based on the transtheoretical model (TTM)
measure: Sport- and Movement-related Self-Concordance (SSK)
time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
description: Questionnaire: Self-concordance/ quality of motivation
measure: Affective explicit attitudes towards performing sports activities
time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
description: Questionnaire: Explicit cognitive and affective attitudes toward sports activities
measure: Breathlessness Catastrophizing
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)
description: Questionnaire: Breathlessness Catastrophizing Scale
measure: Intolerance of Uncertainty Scale (UI-18)
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)
description: Questionnaire: Disposition to react negative on uncertain situations
measure: Life Orientation Test-Revised (LOT-R)
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)
description: Questionnaire: Dispositional optimism
measure: 6 Minute Walking Test
time frame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
description: Functional Test
measure: Satisfaction with the pulmonary rehabilitation
time frame: During the third and thus last week of pulmonary rehabilitation (T2)
description: Questionnaire (self-developed): Satisfaction with interventional components of the pulmonary rehabilitation
measure: Demographic characteristics
time frame: During the first week of pulmonary rehabilitation (T1)
description: Questionnaire: sex, age, height, marital status, education, weight, self-reported work status
measure: Social medical characteristics
time frame: During the first week of pulmonary rehabilitation (T1)
description: Initial physical examination including diagnosis, medication, smoking status, lung function
measure: Sick days and use of health care services
time frame: 6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4)
description: Questionnaire: Days of incapacity to work, days in hospital, COPD-related emergency treatment
measure: Fear avoidance COPD
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)
description: Questionnaire: COPD disease-related fears
measure: Self-reported physical activity
time frame: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
description: Questionnaire: Physical Activity, Exercise, and Sport
arm group label: Pedometer-based activity promotion
arm group type: Experimental
description: In the context of pulmonary rehabilitation (standard care), the intervention group (IG) additionally receives a pedometer-based physical activity behaviour change intervention (BCI).
arm group label: Short patient education and exercise
arm group type: Active Comparator
description: In the context of pulmonary rehabilitation (standard care), the control group (CG) additionally receives a short patient education in combination with related exercise.
intervention type: Behavioral
intervention name: Pedometer-based activity promotion
description: 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.
arm group label: Pedometer-based activity promotion
intervention type: Behavioral
intervention name: Short patient education and exercise
description: 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.
arm group label: Short patient education and exercise
intervention type: Other
intervention name: Pulmonary rehabilitation (Standard care)
description: 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.
arm group label: Pedometer-based activity promotion
arm group label: Short patient education and exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Klaus Pfeifer, Prof. Dr.
role: Principal Investigator
affiliation: Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany
last name: Wolfgang Geidl, Dr.
role: Principal Investigator
affiliation: Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany
last name: Konrad Schultz, Dr.
role: Principal Investigator
affiliation: Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, Bad Reichenhall, Germany
facility: 
country: Germany
citation: Geidl W, Semrau J, Streber R, Lehbert N, Wingart S, Tallner A, Wittmann M, Wagner R, Schultz K, Pfeifer K. Effects of a brief, pedometer-based behavioral intervention for individuals with COPD during inpatient pulmonary rehabilitation on 6-week and 6-month objectively measured physical activity: study protocol for a randomized controlled trial. Trials. 2017 Aug 29;18(1):396. doi: 10.1186/s13063-017-2124-z.
PMID: 28851462
citation: Geidl W, Carl J, Cassar S, Lehbert N, Mino E, Wittmann M, Wagner R, Schultz K, Pfeifer K. Physical Activity and Sedentary Behaviour Patterns in 326 Persons with COPD before Starting a Pulmonary Rehabilitation: A Cluster Analysis. J Clin Med. 2019 Aug 29;8(9):1346. doi: 10.3390/jcm8091346.
PMID: 31470678
citation: Janssens T, Van de Moortel Z, Geidl W, Carl J, Pfeifer K, Lehbert N, Wittmann M, Schultz K, von Leupoldt A. Impact of Disease-Specific Fears on Pulmonary Rehabilitation Trajectories in Patients with COPD. J Clin Med. 2019 Sep 13;8(9):1460. doi: 10.3390/jcm8091460.
PMID: 31540306
responsible party type: Principal Investigator
investigator affiliation: University of Erlangen-Nürnberg
investigator full name: Prof. Dr. Klaus Pfeifer
investigator title: Prof. Dr.
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No