Chronic Obstructive Pulmonary Disease (COPD)STARNCT02966561
Pedometer-based Behavioural Intervention for Individuals With COPD to Stay Active After Rehabilitation
A study testing Pedometer-based activity promotion and Short patient education and exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Erlangen-Nürnberg at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Pedometer-based activity promotion and Short patient education and exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics
Bad Reichenhall, Bavaria, 83435
About this study
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
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.
Read the detailed description
A detailed description will be available in the study protocol publication which is generated at the moment (August, 2016).
- Being tested
- Pedometer-based activity promotion, Short patient education and exercise, Pulmonary rehabilitation (Standard care)
- Keywords
- Pulmonary Rehabilitation, Physical Activity, Behaviour Change, Pedometer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedometer-based activity promotionBehavioural
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.
Short patient education and exerciseBehavioural
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.
Pulmonary rehabilitation (Standard care)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Pedometer-based activity promotion | Experimental | In the context of pulmonary rehabilitation (standard care), the intervention group (IG) additionally receives a pedometer-based physical activity behaviour change intervention (BCI). Receives: Behavioral: Pedometer-based activity promotion; Other: Pulmonary rehabilitation (Standard care) |
| Short patient education and exercise | Active comparator | In the context of pulmonary rehabilitation (standard care), the control group (CG) additionally receives a short patient education in combination with related exercise. Receives: Behavioral: Short patient education and exercise; Other: Pulmonary rehabilitation (Standard care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
Secondary outcomes (22)
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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: During the first week of pulmonary rehabilitation (T1)
Social medical characteristics
Initial physical examination including diagnosis, medication, smoking status, lung function
Measured: 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
Measured: 6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4)
Fear avoidance COPD
Questionnaire: COPD disease-related fears
Measured: 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
Measured: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, German Statutory Pension Insurance
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
- Investigators
- Klaus Pfeifer, Prof. Dr., Principal investigator, Friedrich-Alexander University Erlangen-Nürnberg (FAU), GermanyWolfgang Geidl, Dr., Principal investigator, Friedrich-Alexander University Erlangen-Nürnberg (FAU), GermanyKonrad Schultz, Dr., Principal investigator, Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, Bad Reichenhall, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966561
- Sponsor's protocol ID
- 5.011-6.031.115
- Acronym
- STAR
- Status last verified
- Nov 2020
- First submitted
- 7 Oct 2016
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 28851462Geidl 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.
PubMed 31470678Janssens 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.
PubMed 31540306Carl J, Schultz K, Janssens T, von Leupoldt A, Pfeifer K, Geidl W. The "can do, do do" concept in individuals with chronic obstructive pulmonary disease: an exploration of psychological mechanisms. Respir Res. 2021 Oct 6;22(1):260. doi: 10.1186/s12931-021-01854-1.
PubMed 34615520
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02966561
- Acronym / sponsor ID
- STAR / 5.011-6.031.115
- Keywords
- Pulmonary Rehabilitation, Physical Activity, Behaviour Change, Pedometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, German Statutory Pension Insurance
- Study start
- Jun 2016
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pedometer-based activity promotion | Experimental | Behavioral: Pedometer-based activity promotion, Other: 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). |
| Short patient education and exercise | Active comparator | Behavioral: Short patient education and exercise, Other: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pedometer-based activity promotionThe 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. | Behavioural | Pedometer-based activity promotion |
| Short patient education and exerciseThe 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. | Behavioural | Short patient education and exercise |
| Pulmonary 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. | Other | Pedometer-based activity promotion, Short patient education and exercise |
Primary outcome
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)
On each measurement occasion physical activity is going to be measured on seven consecutive days with a 3-axis accelerometer (Actigraph wGT3X-BT)
22 secondary outcomes
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)
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)
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)
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)
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)
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
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
Satisfaction with the pulmonary rehabilitation
Time frame: During the third and thus last week of pulmonary rehabilitation (T2)
Demographic characteristics
Time frame: During the first week of pulmonary rehabilitation (T1)
Social medical characteristics
Time frame: During the first week of pulmonary rehabilitation (T1)
Sick days and use of health care services
Time frame: 6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- Background: PubMed 28851462Geidl 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.
- Results publication: PubMed 31470678Geidl 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.
- Results publication: PubMed 31540306Janssens 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.
- Derived from this study: PubMed 34615520Carl J, Schultz K, Janssens T, von Leupoldt A, Pfeifer K, Geidl W. The "can do, do do" concept in individuals with chronic obstructive pulmonary disease: an exploration of psychological mechanisms. Respir Res. 2021 Oct 6;22(1):260. doi: 10.1186/s12931-021-01854-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus Pfeifer, Prof. Dr. principal investigator
Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany
Wolfgang Geidl, Dr. principal investigator
Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany
Konrad Schultz, Dr. principal investigator
Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, Bad Reichenhall, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedometer-based activity promotion and Short patient education and exercise in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Erlangen-Nürnberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966561, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2020.