Clinical trial NCT02966561: Pedometer-based Behavioural Intervention for Individuals With COPD to Stay Active After Rehabilitation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Pulmonary Rehabilitation
Physical Activity
Behaviour Change
Pedometer
Lead sponsor: University of Erlangen-Nürnberg
Sponsor class: OTHER
Collaborators: name: Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics
name: German Statutory Pension Insurance
First posted: 2016-11-17
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Changes in objectively measured physical activity
timeFrame: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
Secondary outcomes:
measure: Body-mass index, obstruction, dyspnea, and exercise (BODE index)
timeFrame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
measure: Baseline dyspnea index (BDI) and transitional dyspnea Index (TDI)
timeFrame: 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)
measure: Dyspnea, cough, sputum, pain
timeFrame: 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)
measure: COPD-Anxiety Questionnaire (CAF)
timeFrame: 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)
measure: Patient Health Questionnaire (PHQ-D9)
timeFrame: 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)
measure: St. Georges Respiratory Questionnaire (SGRQ)
timeFrame: 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
measure: COPD Assessment Test (CAT)
timeFrame: 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
measure: Control competence for physical training, physical activity-specific mood regulation and self-control, physical activity-related self efficacy, psychological need satisfaction in exercise
timeFrame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
measure: Single-target Implicit Association Test (ST-IAT)
timeFrame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
measure: Stage of change algorithm for physical activity
timeFrame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
measure: Sport- and Movement-related Self-Concordance (SSK)
timeFrame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
measure: Affective explicit attitudes towards performing sports activities
timeFrame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
measure: Breathlessness Catastrophizing
timeFrame: 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)
measure: Intolerance of Uncertainty Scale (UI-18)
timeFrame: 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)
measure: Life Orientation Test-Revised (LOT-R)
timeFrame: 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)
measure: 6 Minute Walking Test
timeFrame: During the first week of pulmonary rehabilitation (T1); During the third and thus last week of pulmonary rehabilitation (T2)
measure: Satisfaction with the pulmonary rehabilitation
timeFrame: During the third and thus last week of pulmonary rehabilitation (T2)
measure: Demographic characteristics
timeFrame: During the first week of pulmonary rehabilitation (T1)
measure: Social medical characteristics
timeFrame: During the first week of pulmonary rehabilitation (T1)
measure: Sick days and use of health care services
timeFrame: 6 weeks after pulmonary rehabilitation (T3); 6 months after pulmonary rehabilitation (T4)
measure: Fear avoidance COPD
timeFrame: 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)
measure: Self-reported physical activity
timeFrame: 2 weeks before pulmonary rehabilitation (T0), 6 weeks after pulmonary rehabilitation (T3) and 6 months after pulmonary rehabilitation (T4)
Other outcomes:
Locations:
city: Bad Reichenhall
country: Germany
facility: Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics
state: Bavaria
Study officials:
affiliation: Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany
name: Klaus Pfeifer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Friedrich-Alexander University Erlangen-Nürnberg (FAU), Germany
name: Wolfgang Geidl, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, Bad Reichenhall, Germany
name: Konrad Schultz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: Carl 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.