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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— STAR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02966561
• Other study ID #: 5.011-6.031.115
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: December 2019

Study information

• Verified date: November 2020
• Source: University of Erlangen-Nürnberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Behavioral:
• Pedometer-based activity promotion
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 exercise
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.

Other:
• 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.

Locations

Country	Name	City	State
Germany	Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics	Bad Reichenhall	Bavaria

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg	Bad Reichenhall Clinic, Center for Rehabilitation, Pulmonology and Orthopedics, German Statutory Pension Insurance

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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 — View 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. — View 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). pii: E1460. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Demographic characteristics	Questionnaire: sex, age, height, marital status, education, weight, self-reported work status	During the first week of pulmonary rehabilitation (T1)
Secondary	Social medical characteristics	Initial physical examination including diagnosis, medication, smoking status, lung function	During the first week of pulmonary rehabilitation (T1)
Secondary	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)
Secondary	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)
Secondary	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)